Back to resultsChronotherapy for Depressive Episodes
Primary Purpose
Depressive Episode
Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Chronotherapy
Treatment as usual
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Episode
Eligibility Criteria
Inclusion criteria. Patients eligible for the trial must comply with all the following at randomization: Being 18 years or older Willing and able to provide a written informed consent Newly diagnosed with an ongoing moderate or severe depressive episode according to the International Classification of Disorders 10th edition (ICD-10) and accepted for outpatient treatment for the depressive episode. The diagnosis is set in consensus of a licensed therapist and a specialist in psychiatry/psychology. The patient must score ≥ 9 on the Hamilton Depression Rating Scale-6. Must be able to communicate in a Scandinavian language Exclusion criteria. Patients are considered ineligible for participation if any of the following are present: Illnesses where chronotherapy may be contraindicated (for example epilepsy, ongoing attack of multiple sclerosis, blindness, narcolepsy and psychotic depression). Known pregnancy. Individuals with a known diagnosis of emotionally unstable personality disorder (F60.3). Individuals with a known psychotic disorder Shiftwork or other related social or work circumstances that inhibit participation Participation in an ongoing trial at the outpatient clinic that encompasses digital cognitive behavior therapy for insomnia (recruitment to this trial will end in 2023).
Sites / Locations
- St. Olavs Hospital, Nidaros DPSRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Chronotherapy + treatment as usual
Treatment as usual
Arm Description
medication, cognitive behavioral therapy, and other psychotherapies.
Outcomes
Primary Outcome Measures
Between-group difference in self-reported levels of depressive symptoms at week 1 after randomization
Assessed with the Inventory of Depressive Symptomatology Self-Report (IDS-SR), a 30-item questionnaire assessing depressive symptomatology. Items are rated on a Likert scale from 0 to 3, with higher scores indicating more depressive symptoms. The range is 0-84.
Secondary Outcome Measures
Between-group difference in observer-rated levels of depressive symptoms at week 1 after randomization.
Assessed with the Hamilton Depression Rating Scale (HDRS-6), a 6-item questionnaire for depressive symptoms the last 24 hours. Each item is rated on a 0 to 4 rating scale with higher scores indicating more depressive symptoms. The range is 0-22.
Between-group difference in observer-rated levels of depressive symptoms at week 2 after randomization
Assessed with the Hamilton Depression Rating Scale (HDRS-6), a 6-item questionnaire for depressive symptoms the last 24 hours. Each item is rated on a 0 to 4 rating scale with higher scores indicating more depressive symptoms. The range is 0-22.
Between-group difference in observer-rated levels of depressive symptoms at week 4 after randomization.
Assessed with the Hamilton Depression Rating Scale (HDRS-6), a 6-item questionnaire for depressive symptoms the last 24 hours. Each item is rated on a 0 to 4 rating scale with higher scores indicating more depressive symptoms. The range is 0-22.
Between-group difference in observer-rated levels of depressive symptoms at week 8 after randomization
Assessed with the Hamilton Depression Rating Scale (HDRS-6), a 6-item questionnaire for depressive symptoms the last 24 hours. Each item is rated on a 0 to 4 rating scale with higher scores indicating more depressive symptoms. The range is 0-22.
Between-group difference in observer-rated levels of depressive symptoms at week 24 after randomization
Assessed with the Hamilton Depression Rating Scale (HDRS-6), a 6-item questionnaire for depressive symptoms the last 24 hours. Each item is rated on a 0 to 4 rating scale with higher scores indicating more depressive symptoms. The range is 0-22.
Between-group difference in observer-rated levels of depressive symptoms at week 52 after randomization
Assessed with the Hamilton Depression Rating Scale (HDRS-6), a 6-item questionnaire for depressive symptoms the last 24 hours. Each item is rated on a 0 to 4 rating scale with higher scores indicating more depressive symptoms. The range is 0-22.
Between-group difference in self-reported anxiety symptoms at week 1 after randomization
Here assessed with the General Anxiety Disorder (GAD-7), a 7 items self-report scale for central symptoms of anxiety over the last 14 days. The range is 0 to 21, with higher scores indicating more severe anxiety.
Between-group difference in self-reported anxiety symptoms at week 2 after randomization.
Here assessed with the General Anxiety Disorder (GAD-7), a 7 items self-report scale for central symptoms of anxiety over the last 14 days. The range is 0 to 21, with higher scores indicating more severe anxiety.
Between-group difference in self-reported anxiety symptoms at week 4 after randomization
Here assessed with the General Anxiety Disorder (GAD-7), a 7 items self-report scale for central symptoms of anxiety over the last 14 days. The range is 0 to 21, with higher scores indicating more severe anxiety.
Between-group difference in self-reported anxiety symptoms at week 8 after randomization
Here assessed with the General Anxiety Disorder (GAD-7), a 7 items self-report scale for central symptoms of anxiety over the last 14 days. The range is 0 to 21, with higher scores indicating more severe anxiety.
Between-group difference in self-reported anxiety symptoms at week 24 after randomization
Here assessed with the General Anxiety Disorder (GAD-7), a 7 items self-report scale for central symptoms of anxiety over the last 14 days. The range is 0 to 21, with higher scores indicating more severe anxiety.
Between-group difference in self-reported anxiety symptoms at week 52 after randomization
Here assessed with the General Anxiety Disorder (GAD-7), a 7 items self-report scale for central symptoms of anxiety over the last 14 days. The range is 0 to 21, with higher scores indicating more severe anxiety.
Between-group difference in self-reported insomnia symptoms at week 1 after randomization
Here assessed with the Insomnia Severity Index (ISI), a 7-item questionnaire for the severity of insomnia symptoms the last 14 days. Each item is rated on a 0 to 4 rating scale with higher scores indicating more severe symptoms. The ISI has good psychometric properties and is validated for online use. Range is 0-28 with higher values represent higher levels of insomnia symptom severity.
Between-group difference in self-reported insomnia symptoms at week 2 after randomization.
Here assessed with the Insomnia Severity Index (ISI), a 7-item questionnaire for the severity of insomnia symptoms the last 14 days. Each item is rated on a 0 to 4 rating scale with higher scores indicating more severe symptoms. The ISI has good psychometric properties and is validated for online use. Range is 0-28 with higher values represent higher levels of insomnia symptom severity.
Between-group difference in self-reported insomnia symptoms at week 4 after randomization
Here assessed with the Insomnia Severity Index (ISI), a 7-item questionnaire for the severity of insomnia symptoms the last 14 days. Each item is rated on a 0 to 4 rating scale with higher scores indicating more severe symptoms. The ISI has good psychometric properties and is validated for online use. Range is 0-28 with higher values represent higher levels of insomnia symptom severity.
Between-group difference in self-reported insomnia symptoms at week 8 after randomization
Here assessed with the Insomnia Severity Index (ISI), a 7-item questionnaire for the severity of insomnia symptoms the last 14 days. Each item is rated on a 0 to 4 rating scale with higher scores indicating more severe symptoms. The ISI has good psychometric properties and is validated for online use. Range is 0-28 with higher values represent higher levels of insomnia symptom severity.
Between-group difference in self-reported insomnia symptoms at week 24 after randomization
Here assessed with the Insomnia Severity Index (ISI), a 7-item questionnaire for the severity of insomnia symptoms the last 14 days. Each item is rated on a 0 to 4 rating scale with higher scores indicating more severe symptoms. The ISI has good psychometric properties and is validated for online use. Range is 0-28 with higher values represent higher levels of insomnia symptom severity.
Between-group difference in self-reported insomnia symptoms at week 52 after randomization.
Here assessed with the Insomnia Severity Index (ISI), a 7-item questionnaire for the severity of insomnia symptoms the last 14 days. Each item is rated on a 0 to 4 rating scale with higher scores indicating more severe symptoms. The ISI has good psychometric properties and is validated for online use. Range is 0-28 with higher values represent higher levels of insomnia symptom severity.
Prospective daily sleep-wake pattern at day 3 after randomization
Here assessed with the Consensus Sleep Dairy and actigraphy, which will be completed by the participant at baseline and each follow-up point for 14 days.
Prospective daily sleep-wake pattern at day 4 after randomization.
Here assessed with the Consensus Sleep Dairy and actigraphy, which will be completed by the participant at baseline and each follow-up point for 14 days.
Prospective daily sleep-wake pattern at week 1 after randomization.
Here assessed with the Consensus Sleep Dairy and actigraphy, which will be completed by the participant at baseline and each follow-up point for 14 days.
Prospective daily sleep-wake pattern at week 2 after randomization.
Here assessed with the Consensus Sleep Dairy and actigraphy, which will be completed by the participant at baseline and each follow-up point for 14 days.
Prospective daily sleep-wake pattern at week 4 after randomization.
Here assessed with the Consensus Sleep Dairy and actigraphy, which will be completed by the participant at baseline and each follow-up point for 14 days.
Prospective daily sleep-wake pattern at week 8 after randomization
Here assessed with the Consensus Sleep Dairy and actigraphy, which will be completed by the participant at baseline and each follow-up point for 14 days.
Prospective daily sleep-wake pattern at week 24 after randomization.
Here assessed with the Consensus Sleep Dairy and actigraphy, which will be completed by the participant at baseline and each follow-up point for 14 days.
Prospective daily sleep-wake pattern at week 52 after randomization
Here assessed with the Consensus Sleep Dairy and actigraphy, which will be completed by the participant at baseline and each follow-up point for 14 days.
Chronotype at week 8 after randomization.
Here assessed with the Reduced Morningness - Eveningness Questionnaire (rMEQ), a widely used measure of chronotype i.e. time preference for daily activities, including bed-times. The rMEQ has five items yielding scores from 4 to 25, with lower scores indicating "eveningness" and higher scores indicating "morningness". Higher scores indicate higher levels of morningness. Scores can be divided into five categories: definitely evening type (score <8), moderately evening type (Score 8-11), neither type (score 12-17), moderately evening type (score 18-21), and definitely morning type (score >21).
Work and social adjustment at week 1.
Assessed with the Work and Social Adjustment Scale (WSAS). WSAS is a self-administered questionnaire that measures the subjective experience of functionality in work and social environments. The 5 items are rated on an 8-point Likert scale. Total scores range from 0-40, with a higher score indicating more functional impairment.
Work and social adjustment at week 2.
Assessed with the Work and Social Adjustment Scale (WSAS). WSAS is a self-administered questionnaire that measures the subjective experience of functionality in work and social environments. The 5 items are rated on an 8-point Likert scale. Total scores range from 0-40, with a higher score indicating more functional impairment.
Work and social adjustment at week 4.
Assessed with the Work and Social Adjustment Scale (WSAS). WSAS is a self-administered questionnaire that measures the subjective experience of functionality in work and social environments. The 5 items are rated on an 8-point Likert scale. Total scores range from 0-40, with a higher score indicating more functional impairment.
Work and social adjustment at week 8.
Assessed with the Work and Social Adjustment Scale (WSAS). WSAS is a self-administered questionnaire that measures the subjective experience of functionality in work and social environments. The 5 items are rated on an 8-point Likert scale. Total scores range from 0-40, with a higher score indicating more functional impairment.
Work and social adjustment at week 24
Assessed with the Work and Social Adjustment Scale (WSAS). WSAS is a self-administered questionnaire that measures the subjective experience of functionality in work and social environments. The 5 items are rated on an 8-point Likert scale. Total scores range from 0-40, with a higher score indicating more functional impairment.
Work and social adjustment at week 52
Assessed with the Work and Social Adjustment Scale (WSAS). WSAS is a self-administered questionnaire that measures the subjective experience of functionality in work and social environments. The 5 items are rated on an 8-point Likert scale. Total scores range from 0-40, with a higher score indicating more functional impairment.
General health and health-related quality of life at week 1
Assessed with the EQ-5D-5L. The EQ-5D-5L is a self-administered questionnaire that assesses general health and health-related quality of life at the day of measurement. The 5 items are rated on a 5-point Likert scale in addition to a 0-100 rating of overall experienced health condition.
General health and health-related quality of life at week 2.
Assessed with the EQ-5D-5L. The EQ-5D-5L is a self-administered questionnaire that assesses general health and health-related quality of life at the day of measurement. The 5 items are rated on a 5-point Likert scale in addition to a 0-100 rating of overall experienced health condition.
General health and health-related quality of life at week 4.
Assessed with the EQ-5D-5L. The EQ-5D-5L is a self-administered questionnaire that assesses general health and health-related quality of life at the day of measurement. The 5 items are rated on a 5-point Likert scale in addition to a 0-100 rating of overall experienced health condition.
General health and health-related quality of life at week 8
Assessed with the EQ-5D-5L. The EQ-5D-5L is a self-administered questionnaire that assesses general health and health-related quality of life at the day of measurement. The 5 items are rated on a 5-point Likert scale in addition to a 0-100 rating of overall experienced health condition.
General health and health-related quality of life at week 24
Assessed with the EQ-5D-5L. The EQ-5D-5L is a self-administered questionnaire that assesses general health and health-related quality of life at the day of measurement. The 5 items are rated on a 5-point Likert scale in addition to a 0-100 rating of overall experienced health condition.
General health and health-related quality of life at week 52.
Assessed with the EQ-5D-5L. The EQ-5D-5L is a self-administered questionnaire that assesses general health and health-related quality of life at the day of measurement. The 5 items are rated on a 5-point Likert scale in addition to a 0-100 rating of overall experienced health condition.
Patient satisfaction and experienced negative effects at week 4 after randomization
A self-report measure was developed to assess the subjective experiences of patients in the study. The measure includes items to assess whether there have been positive and negative effects of the interventions and will include a free-text space to elaborate if none of the expected effects are experienced.
Serious adverse events will be assessed after 52 weeks after randomization.
Adverse events will be reported to the study team continuously throughout the study period, and will be registered. Any serious adverse events will be reported.
Use of health care services at 52 weeks after randomization.
Assessed through questionnaires and health care records.
Use of health care services at 5 years after randomization
Assessed through questionnaires and health care records.
Use of health care services at 10 years after randomization.
Assessed through questionnaires and health care records.
Between-group difference in self-reported levels of depressive symptoms at day 3 after randomization
Assessed with the Inventory of Depressive Symptomatology Self-Report (IDS-SR), a 30-item questionnaire assessing depressive symptomatology. Items are rated on a Likert scale from 0 to 3, with higher scores indicating more depressive symptoms. The range is 0-84.
Between-group difference in self-reported levels of depressive symptoms at day 4 after randomization
Assessed with the Inventory of Depressive Symptomatology Self-Report (IDS-SR), a 30-item questionnaire assessing depressive symptomatology. Items are rated on a Likert scale from 0 to 3, with higher scores indicating more depressive symptoms. The range is 0-84. On day 4, sleep items will be excluded from the questionnaire.
Between-group difference in self-reported levels of depressive symptoms at week 2 after randomization
Assessed with the Inventory of Depressive Symptomatology Self-Report (IDS-SR), a 30-item questionnaire assessing depressive symptomatology. Items are rated on a Likert scale from 0 to 3, with higher scores indicating more depressive symptoms. The range is 0-84.
Between-group difference in self-reported levels of depressive symptoms at week 4 after randomization
Assessed with the Inventory of Depressive Symptomatology Self-Report (IDS-SR), a 30-item questionnaire assessing depressive symptomatology. Items are rated on a Likert scale from 0 to 3, with higher scores indicating more depressive symptoms. The range is 0-84.
Between-group difference in self-reported levels of depressive symptoms at week 8 after randomization
Assessed with the Inventory of Depressive Symptomatology Self-Report (IDS-SR), a 30-item questionnaire assessing depressive symptomatology. Items are rated on a Likert scale from 0 to 3, with higher scores indicating more depressive symptoms. The range is 0-84.
Between-group difference in self-reported levels of depressive symptoms at week 24 after randomization
Assessed with the Inventory of Depressive Symptomatology Self-Report (IDS-SR), a 30-item questionnaire assessing depressive symptomatology. Items are rated on a Likert scale from 0 to 3, with higher scores indicating more depressive symptoms. The range is 0-84.
Between-group difference in self-reported levels of depressive symptoms at week 52 after randomization
Assessed with the Inventory of Depressive Symptomatology Self-Report (IDS-SR), a 30-item questionnaire assessing depressive symptomatology. Items are rated on a Likert scale from 0 to 3, with higher scores indicating more depressive symptoms. The range is 0-84.
Subjective sleepiness during sleep deprivation
Assessed with the Karolinska Sleepiness Scale (KSS), a 9-item Likert scale, scored from 1 (=extremely alert) to 9 (=extremely sleepy-fighting sleep). The assessment will take place every second hour during the sleep deprivation for the intervention group.
Expectations to the interventions at baseline
Assessed with the Stanford Expectations of Treatment Scale (SETS), a 6-item questionnaire that assesses participants' positive and negative expectations to the interventions on a Likert scale from 1 (strongly disagree) to 7 (strongly agree)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05691647
Brief Title
Chronotherapy for Depressive Episodes
Official Title
Chronotherapy for Patients With a Depressive Episode in a Public Outpatient Mental Health Care Clinic in Norway: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 12, 2023 (Actual)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
January 2040 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Evidence-based treatments for depression, such as antidepressive medication, usually have a latency of 4 to 6 weeks before they achieve a therapeutic effect. Chronotherapy is a group of non-pharmacological interventions that presumably act on the circadian system to achieve a rapid-onset clinical effect and better long-term effects and has been shown efficient to improve depressive symptoms. Interventions include sleep deprivation, sleep-phase advancement and stabilization, and light therapy. There are few studies testing the effectiveness of combining these three chronotherapeutic techniques in the initial phase of treatment of depression in a secondary mental health care outpatient clinic. The investigators aim to test the effects and safety of chronotherapy in addition to TAU compared to TAU alone, with the primary outcome being self-reported depressive symptoms at 1 week following randomization. The study is a randomized controlled trial with 76 patients with a depressive episode who initiate outpatient treatment at Nidaros DPS, St. Olavs University Hospital. Participants will be allocated 1:1 to either chronotherapy + treatment as usual (TAU) or to TAU alone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Episode
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Masking will not be applicable due to the nature of the study, in which participants randomized to receive chronotherapy plus treatment as usual will be admitted to the ward for a one-night sleep deprivation, and the participants and researchers will understand which intervention arm the participant is receiving. Researchers and participants will not be aware of randomization until after baseline-assessments are completed. Analyses will be conducted by a statistician who is blinded to intervention allocation.
Allocation
Randomized
Enrollment
76 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chronotherapy + treatment as usual
Arm Type
Experimental
Arm Title
Treatment as usual
Arm Type
Active Comparator
Arm Description
medication, cognitive behavioral therapy, and other psychotherapies.
Intervention Type
Behavioral
Intervention Name(s)
Chronotherapy
Intervention Description
Chronotherapy involves three different interventions. Sleep deprivation/wake therapy will be conducted for 34 hours. To assist wake and to ensure that the participants adhere to the sleep deprivation, they will be admitted to a one-night stay at the inpatient ward that is connected to the outpatient clinic at Nidaros DPS. Upon discharge, participants are encouraged to adhere to the sleep schedule which presents the sleep-wake phase advancement and later stabilization of the sleep-wake phase. Light therapy is provided for half an hour every day from day four in the study. In addition to the chronotherapeutic interventions, the participants will receive treatment as usual (TAU) with their assigned therapist.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual
Intervention Description
Participants allocated to receive TAU alone, will receive standard treatment for a depressive episode in the outpatient clinic. This study will not give restrictions or guidelines on how this treatment should be performed. The TAU-group will receive the treatment the responsible therapist considers and evaluate best fitting in the situation. Typical interventions administered in therapy for a depressive episode includes medication, cognitive behavioral therapy, and other psychotherapies.
Primary Outcome Measure Information:
Title
Between-group difference in self-reported levels of depressive symptoms at week 1 after randomization
Description
Assessed with the Inventory of Depressive Symptomatology Self-Report (IDS-SR), a 30-item questionnaire assessing depressive symptomatology. Items are rated on a Likert scale from 0 to 3, with higher scores indicating more depressive symptoms. The range is 0-84.
Time Frame
1 week after randomization
Secondary Outcome Measure Information:
Title
Between-group difference in observer-rated levels of depressive symptoms at week 1 after randomization.
Description
Assessed with the Hamilton Depression Rating Scale (HDRS-6), a 6-item questionnaire for depressive symptoms the last 24 hours. Each item is rated on a 0 to 4 rating scale with higher scores indicating more depressive symptoms. The range is 0-22.
Time Frame
1 week after randomization
Title
Between-group difference in observer-rated levels of depressive symptoms at week 2 after randomization
Description
Assessed with the Hamilton Depression Rating Scale (HDRS-6), a 6-item questionnaire for depressive symptoms the last 24 hours. Each item is rated on a 0 to 4 rating scale with higher scores indicating more depressive symptoms. The range is 0-22.
Time Frame
2 weeks after randomization
Title
Between-group difference in observer-rated levels of depressive symptoms at week 4 after randomization.
Description
Assessed with the Hamilton Depression Rating Scale (HDRS-6), a 6-item questionnaire for depressive symptoms the last 24 hours. Each item is rated on a 0 to 4 rating scale with higher scores indicating more depressive symptoms. The range is 0-22.
Time Frame
4 weeks after randomization
Title
Between-group difference in observer-rated levels of depressive symptoms at week 8 after randomization
Description
Assessed with the Hamilton Depression Rating Scale (HDRS-6), a 6-item questionnaire for depressive symptoms the last 24 hours. Each item is rated on a 0 to 4 rating scale with higher scores indicating more depressive symptoms. The range is 0-22.
Time Frame
8 weeks after randomization
Title
Between-group difference in observer-rated levels of depressive symptoms at week 24 after randomization
Description
Assessed with the Hamilton Depression Rating Scale (HDRS-6), a 6-item questionnaire for depressive symptoms the last 24 hours. Each item is rated on a 0 to 4 rating scale with higher scores indicating more depressive symptoms. The range is 0-22.
Time Frame
24 weeks after randomization
Title
Between-group difference in observer-rated levels of depressive symptoms at week 52 after randomization
Description
Assessed with the Hamilton Depression Rating Scale (HDRS-6), a 6-item questionnaire for depressive symptoms the last 24 hours. Each item is rated on a 0 to 4 rating scale with higher scores indicating more depressive symptoms. The range is 0-22.
Time Frame
52 weeks after randomization
Title
Between-group difference in self-reported anxiety symptoms at week 1 after randomization
Description
Here assessed with the General Anxiety Disorder (GAD-7), a 7 items self-report scale for central symptoms of anxiety over the last 14 days. The range is 0 to 21, with higher scores indicating more severe anxiety.
Time Frame
1 week after randomization
Title
Between-group difference in self-reported anxiety symptoms at week 2 after randomization.
Description
Here assessed with the General Anxiety Disorder (GAD-7), a 7 items self-report scale for central symptoms of anxiety over the last 14 days. The range is 0 to 21, with higher scores indicating more severe anxiety.
Time Frame
2 weeks after randomization
Title
Between-group difference in self-reported anxiety symptoms at week 4 after randomization
Description
Here assessed with the General Anxiety Disorder (GAD-7), a 7 items self-report scale for central symptoms of anxiety over the last 14 days. The range is 0 to 21, with higher scores indicating more severe anxiety.
Time Frame
4 weeks after randomization
Title
Between-group difference in self-reported anxiety symptoms at week 8 after randomization
Description
Here assessed with the General Anxiety Disorder (GAD-7), a 7 items self-report scale for central symptoms of anxiety over the last 14 days. The range is 0 to 21, with higher scores indicating more severe anxiety.
Time Frame
8 weeks after randomization
Title
Between-group difference in self-reported anxiety symptoms at week 24 after randomization
Description
Here assessed with the General Anxiety Disorder (GAD-7), a 7 items self-report scale for central symptoms of anxiety over the last 14 days. The range is 0 to 21, with higher scores indicating more severe anxiety.
Time Frame
24 weeks after randomization
Title
Between-group difference in self-reported anxiety symptoms at week 52 after randomization
Description
Here assessed with the General Anxiety Disorder (GAD-7), a 7 items self-report scale for central symptoms of anxiety over the last 14 days. The range is 0 to 21, with higher scores indicating more severe anxiety.
Time Frame
52 weeks after randomization
Title
Between-group difference in self-reported insomnia symptoms at week 1 after randomization
Description
Here assessed with the Insomnia Severity Index (ISI), a 7-item questionnaire for the severity of insomnia symptoms the last 14 days. Each item is rated on a 0 to 4 rating scale with higher scores indicating more severe symptoms. The ISI has good psychometric properties and is validated for online use. Range is 0-28 with higher values represent higher levels of insomnia symptom severity.
Time Frame
1 week after randomization
Title
Between-group difference in self-reported insomnia symptoms at week 2 after randomization.
Description
Here assessed with the Insomnia Severity Index (ISI), a 7-item questionnaire for the severity of insomnia symptoms the last 14 days. Each item is rated on a 0 to 4 rating scale with higher scores indicating more severe symptoms. The ISI has good psychometric properties and is validated for online use. Range is 0-28 with higher values represent higher levels of insomnia symptom severity.
Time Frame
2 weeks after randomization
Title
Between-group difference in self-reported insomnia symptoms at week 4 after randomization
Description
Here assessed with the Insomnia Severity Index (ISI), a 7-item questionnaire for the severity of insomnia symptoms the last 14 days. Each item is rated on a 0 to 4 rating scale with higher scores indicating more severe symptoms. The ISI has good psychometric properties and is validated for online use. Range is 0-28 with higher values represent higher levels of insomnia symptom severity.
Time Frame
4 weeks after randomization
Title
Between-group difference in self-reported insomnia symptoms at week 8 after randomization
Description
Here assessed with the Insomnia Severity Index (ISI), a 7-item questionnaire for the severity of insomnia symptoms the last 14 days. Each item is rated on a 0 to 4 rating scale with higher scores indicating more severe symptoms. The ISI has good psychometric properties and is validated for online use. Range is 0-28 with higher values represent higher levels of insomnia symptom severity.
Time Frame
8 weeks after randomization
Title
Between-group difference in self-reported insomnia symptoms at week 24 after randomization
Description
Here assessed with the Insomnia Severity Index (ISI), a 7-item questionnaire for the severity of insomnia symptoms the last 14 days. Each item is rated on a 0 to 4 rating scale with higher scores indicating more severe symptoms. The ISI has good psychometric properties and is validated for online use. Range is 0-28 with higher values represent higher levels of insomnia symptom severity.
Time Frame
24 weeks after randomization
Title
Between-group difference in self-reported insomnia symptoms at week 52 after randomization.
Description
Here assessed with the Insomnia Severity Index (ISI), a 7-item questionnaire for the severity of insomnia symptoms the last 14 days. Each item is rated on a 0 to 4 rating scale with higher scores indicating more severe symptoms. The ISI has good psychometric properties and is validated for online use. Range is 0-28 with higher values represent higher levels of insomnia symptom severity.
Time Frame
52 weeks after randomization
Title
Prospective daily sleep-wake pattern at day 3 after randomization
Description
Here assessed with the Consensus Sleep Dairy and actigraphy, which will be completed by the participant at baseline and each follow-up point for 14 days.
Time Frame
3 days after randomization.
Title
Prospective daily sleep-wake pattern at day 4 after randomization.
Description
Here assessed with the Consensus Sleep Dairy and actigraphy, which will be completed by the participant at baseline and each follow-up point for 14 days.
Time Frame
4 days after randomization.
Title
Prospective daily sleep-wake pattern at week 1 after randomization.
Description
Here assessed with the Consensus Sleep Dairy and actigraphy, which will be completed by the participant at baseline and each follow-up point for 14 days.
Time Frame
1 week after randomization.
Title
Prospective daily sleep-wake pattern at week 2 after randomization.
Description
Here assessed with the Consensus Sleep Dairy and actigraphy, which will be completed by the participant at baseline and each follow-up point for 14 days.
Time Frame
2 weeks after randomization.
Title
Prospective daily sleep-wake pattern at week 4 after randomization.
Description
Here assessed with the Consensus Sleep Dairy and actigraphy, which will be completed by the participant at baseline and each follow-up point for 14 days.
Time Frame
4 weeks after randomization.
Title
Prospective daily sleep-wake pattern at week 8 after randomization
Description
Here assessed with the Consensus Sleep Dairy and actigraphy, which will be completed by the participant at baseline and each follow-up point for 14 days.
Time Frame
8 weeks after randomization.
Title
Prospective daily sleep-wake pattern at week 24 after randomization.
Description
Here assessed with the Consensus Sleep Dairy and actigraphy, which will be completed by the participant at baseline and each follow-up point for 14 days.
Time Frame
24 weeks after randomization.
Title
Prospective daily sleep-wake pattern at week 52 after randomization
Description
Here assessed with the Consensus Sleep Dairy and actigraphy, which will be completed by the participant at baseline and each follow-up point for 14 days.
Time Frame
52 weeks after randomization.
Title
Chronotype at week 8 after randomization.
Description
Here assessed with the Reduced Morningness - Eveningness Questionnaire (rMEQ), a widely used measure of chronotype i.e. time preference for daily activities, including bed-times. The rMEQ has five items yielding scores from 4 to 25, with lower scores indicating "eveningness" and higher scores indicating "morningness". Higher scores indicate higher levels of morningness. Scores can be divided into five categories: definitely evening type (score <8), moderately evening type (Score 8-11), neither type (score 12-17), moderately evening type (score 18-21), and definitely morning type (score >21).
Time Frame
8 weeks after randomization
Title
Work and social adjustment at week 1.
Description
Assessed with the Work and Social Adjustment Scale (WSAS). WSAS is a self-administered questionnaire that measures the subjective experience of functionality in work and social environments. The 5 items are rated on an 8-point Likert scale. Total scores range from 0-40, with a higher score indicating more functional impairment.
Time Frame
1 week after randomization.
Title
Work and social adjustment at week 2.
Description
Assessed with the Work and Social Adjustment Scale (WSAS). WSAS is a self-administered questionnaire that measures the subjective experience of functionality in work and social environments. The 5 items are rated on an 8-point Likert scale. Total scores range from 0-40, with a higher score indicating more functional impairment.
Time Frame
2 weeks after randomization.
Title
Work and social adjustment at week 4.
Description
Assessed with the Work and Social Adjustment Scale (WSAS). WSAS is a self-administered questionnaire that measures the subjective experience of functionality in work and social environments. The 5 items are rated on an 8-point Likert scale. Total scores range from 0-40, with a higher score indicating more functional impairment.
Time Frame
4 weeks after randomization
Title
Work and social adjustment at week 8.
Description
Assessed with the Work and Social Adjustment Scale (WSAS). WSAS is a self-administered questionnaire that measures the subjective experience of functionality in work and social environments. The 5 items are rated on an 8-point Likert scale. Total scores range from 0-40, with a higher score indicating more functional impairment.
Time Frame
8 weeks after randomization
Title
Work and social adjustment at week 24
Description
Assessed with the Work and Social Adjustment Scale (WSAS). WSAS is a self-administered questionnaire that measures the subjective experience of functionality in work and social environments. The 5 items are rated on an 8-point Likert scale. Total scores range from 0-40, with a higher score indicating more functional impairment.
Time Frame
24 weeks after randomization
Title
Work and social adjustment at week 52
Description
Assessed with the Work and Social Adjustment Scale (WSAS). WSAS is a self-administered questionnaire that measures the subjective experience of functionality in work and social environments. The 5 items are rated on an 8-point Likert scale. Total scores range from 0-40, with a higher score indicating more functional impairment.
Time Frame
52 weeks after randomization
Title
General health and health-related quality of life at week 1
Description
Assessed with the EQ-5D-5L. The EQ-5D-5L is a self-administered questionnaire that assesses general health and health-related quality of life at the day of measurement. The 5 items are rated on a 5-point Likert scale in addition to a 0-100 rating of overall experienced health condition.
Time Frame
1 week after randomization.
Title
General health and health-related quality of life at week 2.
Description
Assessed with the EQ-5D-5L. The EQ-5D-5L is a self-administered questionnaire that assesses general health and health-related quality of life at the day of measurement. The 5 items are rated on a 5-point Likert scale in addition to a 0-100 rating of overall experienced health condition.
Time Frame
2 weeks after randomization.
Title
General health and health-related quality of life at week 4.
Description
Assessed with the EQ-5D-5L. The EQ-5D-5L is a self-administered questionnaire that assesses general health and health-related quality of life at the day of measurement. The 5 items are rated on a 5-point Likert scale in addition to a 0-100 rating of overall experienced health condition.
Time Frame
4 weeks after randomization.
Title
General health and health-related quality of life at week 8
Description
Assessed with the EQ-5D-5L. The EQ-5D-5L is a self-administered questionnaire that assesses general health and health-related quality of life at the day of measurement. The 5 items are rated on a 5-point Likert scale in addition to a 0-100 rating of overall experienced health condition.
Time Frame
8 weeks after randomization.
Title
General health and health-related quality of life at week 24
Description
Assessed with the EQ-5D-5L. The EQ-5D-5L is a self-administered questionnaire that assesses general health and health-related quality of life at the day of measurement. The 5 items are rated on a 5-point Likert scale in addition to a 0-100 rating of overall experienced health condition.
Time Frame
24 weeks after randomization.
Title
General health and health-related quality of life at week 52.
Description
Assessed with the EQ-5D-5L. The EQ-5D-5L is a self-administered questionnaire that assesses general health and health-related quality of life at the day of measurement. The 5 items are rated on a 5-point Likert scale in addition to a 0-100 rating of overall experienced health condition.
Time Frame
52 weeks after randomization.
Title
Patient satisfaction and experienced negative effects at week 4 after randomization
Description
A self-report measure was developed to assess the subjective experiences of patients in the study. The measure includes items to assess whether there have been positive and negative effects of the interventions and will include a free-text space to elaborate if none of the expected effects are experienced.
Time Frame
4 weeks after randomization.
Title
Serious adverse events will be assessed after 52 weeks after randomization.
Description
Adverse events will be reported to the study team continuously throughout the study period, and will be registered. Any serious adverse events will be reported.
Time Frame
52 weeks after randomization.
Title
Use of health care services at 52 weeks after randomization.
Description
Assessed through questionnaires and health care records.
Time Frame
52 weeks after randomization
Title
Use of health care services at 5 years after randomization
Description
Assessed through questionnaires and health care records.
Time Frame
5 years after randomization
Title
Use of health care services at 10 years after randomization.
Description
Assessed through questionnaires and health care records.
Time Frame
10 years after randomization.
Title
Between-group difference in self-reported levels of depressive symptoms at day 3 after randomization
Description
Assessed with the Inventory of Depressive Symptomatology Self-Report (IDS-SR), a 30-item questionnaire assessing depressive symptomatology. Items are rated on a Likert scale from 0 to 3, with higher scores indicating more depressive symptoms. The range is 0-84.
Time Frame
3 days after randomization
Title
Between-group difference in self-reported levels of depressive symptoms at day 4 after randomization
Description
Assessed with the Inventory of Depressive Symptomatology Self-Report (IDS-SR), a 30-item questionnaire assessing depressive symptomatology. Items are rated on a Likert scale from 0 to 3, with higher scores indicating more depressive symptoms. The range is 0-84. On day 4, sleep items will be excluded from the questionnaire.
Time Frame
4 days after randomization
Title
Between-group difference in self-reported levels of depressive symptoms at week 2 after randomization
Description
Assessed with the Inventory of Depressive Symptomatology Self-Report (IDS-SR), a 30-item questionnaire assessing depressive symptomatology. Items are rated on a Likert scale from 0 to 3, with higher scores indicating more depressive symptoms. The range is 0-84.
Time Frame
14 days after randomization
Title
Between-group difference in self-reported levels of depressive symptoms at week 4 after randomization
Description
Assessed with the Inventory of Depressive Symptomatology Self-Report (IDS-SR), a 30-item questionnaire assessing depressive symptomatology. Items are rated on a Likert scale from 0 to 3, with higher scores indicating more depressive symptoms. The range is 0-84.
Time Frame
4 weeks after randomization
Title
Between-group difference in self-reported levels of depressive symptoms at week 8 after randomization
Description
Assessed with the Inventory of Depressive Symptomatology Self-Report (IDS-SR), a 30-item questionnaire assessing depressive symptomatology. Items are rated on a Likert scale from 0 to 3, with higher scores indicating more depressive symptoms. The range is 0-84.
Time Frame
8 weeks after randomization
Title
Between-group difference in self-reported levels of depressive symptoms at week 24 after randomization
Description
Assessed with the Inventory of Depressive Symptomatology Self-Report (IDS-SR), a 30-item questionnaire assessing depressive symptomatology. Items are rated on a Likert scale from 0 to 3, with higher scores indicating more depressive symptoms. The range is 0-84.
Time Frame
24 weeks after randomization
Title
Between-group difference in self-reported levels of depressive symptoms at week 52 after randomization
Description
Assessed with the Inventory of Depressive Symptomatology Self-Report (IDS-SR), a 30-item questionnaire assessing depressive symptomatology. Items are rated on a Likert scale from 0 to 3, with higher scores indicating more depressive symptoms. The range is 0-84.
Time Frame
52 weeks after randomization
Title
Subjective sleepiness during sleep deprivation
Description
Assessed with the Karolinska Sleepiness Scale (KSS), a 9-item Likert scale, scored from 1 (=extremely alert) to 9 (=extremely sleepy-fighting sleep). The assessment will take place every second hour during the sleep deprivation for the intervention group.
Time Frame
Day 3-4 after randomization
Title
Expectations to the interventions at baseline
Description
Assessed with the Stanford Expectations of Treatment Scale (SETS), a 6-item questionnaire that assesses participants' positive and negative expectations to the interventions on a Likert scale from 1 (strongly disagree) to 7 (strongly agree)
Time Frame
Day 0 after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria. Patients eligible for the trial must comply with all the following at randomization:
Being 18 years or older
Willing and able to provide a written informed consent
Newly diagnosed with an ongoing moderate or severe depressive episode according to the International Classification of Disorders 10th edition (ICD-10) and accepted for outpatient treatment for the depressive episode. The diagnosis is set in consensus of a licensed therapist and a specialist in psychiatry/psychology.
The patient must score ≥ 9 on the Hamilton Depression Rating Scale-6.
Must be able to communicate in a Scandinavian language
Exclusion criteria. Patients are considered ineligible for participation if any of the following are present:
Illnesses where chronotherapy may be contraindicated (for example epilepsy, ongoing attack of multiple sclerosis, blindness, narcolepsy and psychotic depression).
Known pregnancy.
Individuals with a known diagnosis of emotionally unstable personality disorder (F60.3).
Individuals with a known psychotic disorder
Shiftwork or other related social or work circumstances that inhibit participation
Participation in an ongoing trial at the outpatient clinic that encompasses digital cognitive behavior therapy for insomnia (recruitment to this trial will end in 2023).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Knut Langsrud, PhD, MD
Phone
+47 92647191
Email
knut.langsrud@stolav.no
Facility Information:
Facility Name
St. Olavs Hospital, Nidaros DPS
City
Trondheim
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Knut Langsrud, PhD, MD
12. IPD Sharing Statement
Learn more about this trial
Chronotherapy for Depressive Episodes
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