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Cognitive Behavior Therapy for Insomnia: Analysis of Components, Mediators and Moderators

Primary Purpose

Sleep Initiation and Maintenance Disorders

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Cognitive Therapy
Behavior Therapy
Waitlist.
Sponsored by
Stockholm University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Initiation and Maintenance Disorders focused on measuring Cognitive therapy, Behavior therapy, Moderation, Mediation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Presence of insomnia more than three nights per week and for more than three months.
  • Insomnia despite adequate opportunity to sleep.
  • Insomnia severity typical for insomnia disorder, i.e. 11 points or more on the Insomnia Severity Index (ISI).
  • Nighttime insomnia symptoms, i.e., two points or more on at least one of the first three ISI questions.
  • Daytime insomnia symptoms, i.e. two points or more on one or both of the ISI distress and impairment items (numbers 5 and 7).
  • Clinical insomnia symptoms from sleep diaries concerning three nighttime symptoms (difficulties with sleep initiation, difficulties with sleep maintenance, and early morning awakenings), i.e., thirty minutes or more on average on one or more of the symptoms.
  • No current or past CBT-I treatment within the past 5 years.
  • Time and opportunity to participate in treatment for ten weeks.
  • Time and opportunity to read approximately fifteen pages per week and execute homework assignments for ten weeks.
  • Access to a computer, email and internet.

Exclusion Criteria:

  • Severe depression, i.e., more than 30 points on MADRS-S.
  • Suicidal risk, i.e., 4 points or more on item 9 on MADRS-S.
  • A high intake of alcohol or caffeine,
  • Insomnia due to shiftwork or other sleep-disturbing events (e.g., pregnancy, small children, or animals in the sleep environment).
  • Participants with a history of psychotic or bipolar disorder.
  • If a somatic condition is reported, it is required that it is relatively stable and/or that the candidate is receiving treatment for the condition.
  • When a candidate fulfills criteria for a psychiatric or somatic condition, it is required that insomnia is the disorder currently most distressing and disabling or that the insomnia remains despite treatment for the comorbid condition.
  • Participants with the following primary sleep disorders will be excluded via the Duke Structured Interview for Sleep Disorders (DSISD): sleep apnea, restless legs syndrome, periodic limb movement disorder, circadian rhythm disorder, and parasomnias.
  • If sleep medication is used, it is required that the use has been relatively stable during three months.
  • If Selective Serotonin Reuptake Inhibitors (SSRI) use is reported, it is required that the onset of the medication was at least three months prior to the telephone interview.
  • Participants who regularly consume sleep-disturbing medications.

Sites / Locations

  • Stockholm University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Behavior Therapy

Cognitive Therapy

Waitlist

Arm Description

Outcomes

Primary Outcome Measures

Changes on the insomnia severity index (ISI).

Secondary Outcome Measures

Changes on the Work and Social Adjustment Scale (WSAS).
Changes in sleep onset latency (SOL).
Changes in wake time after sleep onset (WASO).
Changes in early morning awakenings (EMA).
Changes in total sleep time (TST).
Changes in Hospital Anxiety and Depression Scale (HADS)
Changes in nighttime symptoms, by using item 1 - 3 from the primary outcome measure.
Changes in impairment, by using item 5 and 6 from the primary outcome measure.
Changes in distress, by using item 4 and 7 from the primary outcome measure.
Changes in Brunnsviken Brief Quality of life index (BBQ)

Full Information

First Posted
November 21, 2016
Last Updated
April 17, 2018
Sponsor
Stockholm University
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1. Study Identification

Unique Protocol Identification Number
NCT02984670
Brief Title
Cognitive Behavior Therapy for Insomnia: Analysis of Components, Mediators and Moderators
Official Title
Cognitive Behavior Therapy for Insomnia: Analysis of Components, Mediators and Moderators
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stockholm University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The overall purpose with this investigation is to further our knowledge about cognitive behavioral therapy (CBT) for insomnia by examining treatment components, mediators, and moderators. The first aim that will be addressed is to explore the efficacy of the CBT components with a dismantling-treatment strategy. Two active CBT interventions, intended to define its components - cognitive therapy and behavior therapy - will be compared with one another as well as with a waitlist condition on a broad range of outcomes at five to nine assessment points depending on the measures. The design will thus enable us to examine what CBT component or components are necessary, sufficient and facilitative of therapeutic change. The second aim that will be explored is to investigate what processes occur in CBT that may contribute to treatment outcome with a treatment-mediator strategy. To examine mediators for CBT, the following mediators will be assessed; Anxiety and Preoccupation about sleep Questionnaire (APSQ), Dysfunctional Beliefs and Attitudes about Sleep (DBAS), Sleep Associated Monitoring Index (SAMI), Sleep-Related Behavior Questionnaire (SRBQ), time in bed, napping, bedtime variability, and rise time variability. The hypothesis is that cognitive processes will mediate cognitive therapy outcomes, and that behavioral factors will have a mediating role for behavior therapy improvements. The third aim that will be addressed is to examine what patient characteristics does CBT depend on to be effective with a treatment-moderator strategy. To investigate moderators for CBT, the following moderators will be assessed; age, gender, occupational status, level of education, initial insomnia severity, dysfunction, medication use, chronic pain, psychiatric co-morbidity, medical co-morbidity, behavioral and cognitive processes used as mediators will also be employed as moderators.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Initiation and Maintenance Disorders
Keywords
Cognitive therapy, Behavior therapy, Moderation, Mediation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
219 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Behavior Therapy
Arm Type
Experimental
Arm Title
Cognitive Therapy
Arm Type
Experimental
Arm Title
Waitlist
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Therapy
Intervention Description
Cognitive Therapy involves challenging negative automatic thoughts about sleep and the use of behavioral experiments to challenge and test five cognitive processes (i.e., worry, dysfunctional thoughts, monitoring, safety behaviours, misperception) proposed to perpetuate insomnia.
Intervention Type
Behavioral
Intervention Name(s)
Behavior Therapy
Intervention Description
Behavior Therapy involves the use of stimulus control and sleep restriction in order to reverse maladaptive sleep habits (time in bed, napping, bedtime variability, rise time variability) proposed to maintain insomnia. It also involves the practice of sleep hygiene principles.
Intervention Type
Behavioral
Intervention Name(s)
Waitlist.
Intervention Description
The waitlist serves as a passive control which will receive the same measures administered to the cognitive and behaviour therapy groups.
Primary Outcome Measure Information:
Title
Changes on the insomnia severity index (ISI).
Time Frame
Pretreatment (week 0), during treatment (i.e., at week: 2, 4, 6, 8), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment.
Secondary Outcome Measure Information:
Title
Changes on the Work and Social Adjustment Scale (WSAS).
Time Frame
Pretreatment (week 0), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment.
Title
Changes in sleep onset latency (SOL).
Time Frame
Pretreatment (week 0), during treatment (week: 2, 4, 6, 8) and post-treatment (week 10).
Title
Changes in wake time after sleep onset (WASO).
Time Frame
Pretreatment (week 0), during treatment (week: 2, 4, 6, 8) and post-treatment (week 10).
Title
Changes in early morning awakenings (EMA).
Time Frame
Pretreatment (week 0), during treatment (week: 2, 4, 6, 8) and post-treatment (week 10).
Title
Changes in total sleep time (TST).
Time Frame
Pretreatment (week 0), during treatment (week: 2, 4, 6, 8) and post-treatment (week 10).
Title
Changes in Hospital Anxiety and Depression Scale (HADS)
Time Frame
Pretreatment (week 0), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment.
Title
Changes in nighttime symptoms, by using item 1 - 3 from the primary outcome measure.
Time Frame
Pretreatment (week 0), during treatment (week: 2, 4, 6, 8), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment.
Title
Changes in impairment, by using item 5 and 6 from the primary outcome measure.
Time Frame
Pretreatment (week 0), during treatment (week: 2, 4, 6, 8), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment.
Title
Changes in distress, by using item 4 and 7 from the primary outcome measure.
Time Frame
Pretreatment (week 0), during treatment (week: 2, 4, 6, 8), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment.
Title
Changes in Brunnsviken Brief Quality of life index (BBQ)
Time Frame
Pretreatment (week 0), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment.
Other Pre-specified Outcome Measures:
Title
Credibility Expectancy Questionnaire (CEQ ).
Time Frame
During the first treatment module.
Title
Client Satisfaction Questionnaire (CSQ-8).
Time Frame
Post-treatment (week 10).
Title
Activity and adherence with treatment protocol (self developed questionnaire assessing treatment activity and adherence relating to text, homework and therapist support).
Time Frame
Post-treatment (week 10).
Title
Sick-leave and other concomitant treatment (self developed questionnaire).
Time Frame
Post-treatment (week 10).
Title
Adverse events (questionnaire from a previous similar study).
Time Frame
Post-treatment (week 10).
Title
Changes in physical activity (self developed questionnaire).
Time Frame
Pretreatment (week 0) and post-treatment (week 10).
Title
Changes in Ford Insomnia Response To Stress Test (FIRST).
Time Frame
Pretreatment (week 0) and post-treatment (week 10) for the waitlist.
Title
Changes in Daytime Insomnia Symptom Response Scale (DISRS)
Time Frame
Pretreatment (week 0) and post-treatment (week 10) for the waitlist.
Title
Montgomery Åsberg Depression Rating Scale (MADRS).
Time Frame
Pretreatment (week 0).
Title
Changes in suicide risk (Item 9 from the MADRS).
Time Frame
Pretreatment (week 0), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Presence of insomnia more than three nights per week and for more than three months. Insomnia despite adequate opportunity to sleep. Insomnia severity typical for insomnia disorder, i.e. 11 points or more on the Insomnia Severity Index (ISI). Nighttime insomnia symptoms, i.e., two points or more on at least one of the first three ISI questions. Daytime insomnia symptoms, i.e. two points or more on one or both of the ISI distress and impairment items (numbers 5 and 7). Clinical insomnia symptoms from sleep diaries concerning three nighttime symptoms (difficulties with sleep initiation, difficulties with sleep maintenance, and early morning awakenings), i.e., thirty minutes or more on average on one or more of the symptoms. No current or past CBT-I treatment within the past 5 years. Time and opportunity to participate in treatment for ten weeks. Time and opportunity to read approximately fifteen pages per week and execute homework assignments for ten weeks. Access to a computer, email and internet. Exclusion Criteria: Severe depression, i.e., more than 30 points on MADRS-S. Suicidal risk, i.e., 4 points or more on item 9 on MADRS-S. A high intake of alcohol or caffeine, Insomnia due to shiftwork or other sleep-disturbing events (e.g., pregnancy, small children, or animals in the sleep environment). Participants with a history of psychotic or bipolar disorder. If a somatic condition is reported, it is required that it is relatively stable and/or that the candidate is receiving treatment for the condition. When a candidate fulfills criteria for a psychiatric or somatic condition, it is required that insomnia is the disorder currently most distressing and disabling or that the insomnia remains despite treatment for the comorbid condition. Participants with the following primary sleep disorders will be excluded via the Duke Structured Interview for Sleep Disorders (DSISD): sleep apnea, restless legs syndrome, periodic limb movement disorder, circadian rhythm disorder, and parasomnias. If sleep medication is used, it is required that the use has been relatively stable during three months. If Selective Serotonin Reuptake Inhibitors (SSRI) use is reported, it is required that the onset of the medication was at least three months prior to the telephone interview. Participants who regularly consume sleep-disturbing medications.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus Jansson Fröjmark, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stockholm University
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36074617
Citation
Sunnhed R, Hesser H, Andersson G, Carlbring P, Lindner P, Harvey AG, Jansson-Frojmark M. Mediators of cognitive therapy and behavior therapy for insomnia disorder: A test of the processes in the cognitive model. J Consult Clin Psychol. 2022 Sep;90(9):696-708. doi: 10.1037/ccp0000756. Epub 2022 Sep 8.
Results Reference
derived
PubMed Identifier
33630618
Citation
Blanken TF, Jansson-Frojmark M, Sunnhed R, Lancee J. Symptom-specific effects of cognitive therapy and behavior therapy for insomnia: A network intervention analysis. J Consult Clin Psychol. 2021 Apr;89(4):364-370. doi: 10.1037/ccp0000625. Epub 2021 Feb 25.
Results Reference
derived
PubMed Identifier
31608389
Citation
Sunnhed R, Hesser H, Andersson G, Carlbring P, Morin CM, Harvey AG, Jansson-Frojmark M. Comparing internet-delivered cognitive therapy and behavior therapy with telephone support for insomnia disorder: a randomized controlled trial. Sleep. 2020 Feb 13;43(2):zsz245. doi: 10.1093/sleep/zsz245.
Results Reference
derived
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/24865869
Description
Comparative Efficacy of Behavior Therapy, Cognitive Therapy, and Cognitive Behavior Therapy for Chronic Insomnia: A Randomized Controlled Trial

Learn more about this trial

Cognitive Behavior Therapy for Insomnia: Analysis of Components, Mediators and Moderators

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