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The Efficacy of a Transdiagnostic Sleep and Circadian Intervention for Patients With Mental Disorders and Sleep Problems

Primary Purpose

Depression, Bipolar Affective Disorder, Attention Deficit Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Transdiagnostic sleep and circadian treatment
Active waitlist control group
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

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

Inclusion Criteria:

  • Age ≥18 years
  • F31 Bipolar disorder, F32 unipolar depression or F90 attention deficit disorder
  • Insomnia Severity Index (ISI) ≥ 14 (exceeding the threshold for a sleep problem)
  • Sleep problems for 3 months: 3 times a week at least one of the following:

    • Sleep onset latency ≥ 30 minutes
    • Wake after sleep onset ≥ 30 minutes
    • Total sleep time ≥ 11 hours per day
    • Displaced circadian rhythm; sleeps earlier than 8 P.M. or later than 02 A.M.
    • Irregular circadian rhythm; bedtime varies ≥ 3 hours throughout the week

Exclusion Criteria:

  • Acutely increased suicide risk (Central Regions guideline for assessment of suicide risk)
  • Active substance abuse (F10-19)
  • The sleep problem can be significantly explained by insufficient treatment of physical
  • disease affecting sleep (documented in patients electronic journal)
  • Unstable social situation (does not have a permanent residence)
  • Shift work (≥ 2 times a week for the last 2 months)
  • Pregnancy and breast-feeding

Sites / Locations

  • Mette KraghRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Transdiagnostic sleep and circadian treatment

Active waitlist control group

Arm Description

The intervention group receives sleep treatment consisting of 6 sessions of 60 minutes each over 6 weeks.

The control group receives sleep hygiene education

Outcomes

Primary Outcome Measures

Change in the severity of the sleep problem
Is measured by Insomnia Severity Index. A self-report instrument measuring the patient's perception of insomnia. The scale ranges from 0 to 28. The higher the score the more severe the insomnia.
Change in sleep quality.
Measured by Pittsburgh Sleeping Quality Index (PSQI). The score is between 0 and 21, "0" indicating no difficulty and "21" indicating severe difficulties.

Secondary Outcome Measures

Change in well-being
Measured on The WHO-5 Well-Being Index (WHO-5). A questionnaire which measures well-being on a scale ranging from 0 to 100, the higher the score the more well-being.
Level of personal recovery
Measured by the questionnaire INSPIRE-O. A questionnaire which measures personal recovery on a scale ranging from 5 to 25, the higher the score the more recovery.
Change in readiness to take on a job
Measured by the questionnaire, The Work Ability Index. A score of 0 shows the lowest possibility that the person would take on a job, the score 10 is the highest possibility
Changes in health-related items.
The International EQ-5D-5L questionnaire is applied to estimate quality-adjusted years of life.
Change in consumption of sleep medications
Daily use of sedatives and hypnotics will be measured by medication registration use in sleep diaries during the study period.
Changes in sleep efficiency
Is calculated based on the participant's registrations in sleep diaries and by measurements from actigraphs.
Changes in sleep latency
Is calculated based on the participant's registrations in sleep diaries and by measurements from actigraphs.
Changes in sleep nocturnal awakenings
Is calculated based on the participant's registrations in sleep diaries and by measurements from actigraphs.

Full Information

First Posted
June 1, 2022
Last Updated
June 13, 2022
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT05406414
Brief Title
The Efficacy of a Transdiagnostic Sleep and Circadian Intervention for Patients With Mental Disorders and Sleep Problems
Official Title
Better Sleep Without Medicine - a Cross-sectoral, Quantitative and Qualitative Study for Adult Patients With Mental Disorders and Sleep Problems
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2022 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to examine the effect of a non-pharmacological transdiagnostic sleep intervention as add on to standard treatment for bipolar disorder, depression and attention deficit disorder. Our hypothesis is that the intervention will reduce the severity of the sleep problem and increase sleep quality compared to a control group receiving sleep hygiene education.
Detailed Description
Sleep problems include insomnia, circadian rhythm disorders, hypersomnia, and inadequate sleep hygiene. Patients suffering from mental illness are more likely to suffer from sleep problems than the general population. Sleep problems can aggravate the underlying disorder, cause relapse and suicidal ideation. Sleep problems often persist after the mental disorder is successfully treated. Sleep medication is often used but not recommended for long term use. Non-pharmacological treatment of sleep problems is in demand by patients, but treatment options are few. The present intervention is based on a transdiagnostic manual combining Cognitive Behavioral Therapy for Insomnia with chronotherapy, but more research on the efficacy is warranted. The aim of this study is to investigate whether the intervention reduces the severity of the sleep problem, increases sleep quality, leads to increased sleep efficiency, reduces sleep latency and awakenings, provides better quality of life, increases personal recovery, provides greater readiness to take on a job or reduces consumption of sleep medication.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Bipolar Affective Disorder, Attention Deficit Disorder

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Transdiagnostic sleep and circadian treatment
Arm Type
Experimental
Arm Description
The intervention group receives sleep treatment consisting of 6 sessions of 60 minutes each over 6 weeks.
Arm Title
Active waitlist control group
Arm Type
Active Comparator
Arm Description
The control group receives sleep hygiene education
Intervention Type
Behavioral
Intervention Name(s)
Transdiagnostic sleep and circadian treatment
Intervention Description
The intervention group receives sleep treatment consisting of 6 sessions of 60 minutes each over 6 weeks. The sessions are delivered individually and have the following content: Assessment and introduction to the sleep diary Review of sleep diary - agreements on behavior changes and goals. Information on normal sleep, sleep problems and circadian rhythm Cognitive techniques Introduction to relaxation training Follow-up on goals and plan for prevention relapse of sleep problems
Intervention Type
Behavioral
Intervention Name(s)
Active waitlist control group
Intervention Description
The control group receives sleep hygiene education consisting of a single session in which 10 points of sleep advice are presented. They receive a booklet on how to promote good sleep practice and must work on their own for the next 6 weeks to implement this while waiting for the intervention.
Primary Outcome Measure Information:
Title
Change in the severity of the sleep problem
Description
Is measured by Insomnia Severity Index. A self-report instrument measuring the patient's perception of insomnia. The scale ranges from 0 to 28. The higher the score the more severe the insomnia.
Time Frame
Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint)
Title
Change in sleep quality.
Description
Measured by Pittsburgh Sleeping Quality Index (PSQI). The score is between 0 and 21, "0" indicating no difficulty and "21" indicating severe difficulties.
Time Frame
Is measured at inclusion (baseline/ week 0) and at week 6 (endpoint).
Secondary Outcome Measure Information:
Title
Change in well-being
Description
Measured on The WHO-5 Well-Being Index (WHO-5). A questionnaire which measures well-being on a scale ranging from 0 to 100, the higher the score the more well-being.
Time Frame
Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint
Title
Level of personal recovery
Description
Measured by the questionnaire INSPIRE-O. A questionnaire which measures personal recovery on a scale ranging from 5 to 25, the higher the score the more recovery.
Time Frame
Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint).
Title
Change in readiness to take on a job
Description
Measured by the questionnaire, The Work Ability Index. A score of 0 shows the lowest possibility that the person would take on a job, the score 10 is the highest possibility
Time Frame
Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint)
Title
Changes in health-related items.
Description
The International EQ-5D-5L questionnaire is applied to estimate quality-adjusted years of life.
Time Frame
Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint)
Title
Change in consumption of sleep medications
Description
Daily use of sedatives and hypnotics will be measured by medication registration use in sleep diaries during the study period.
Time Frame
Is registered daily during the 6 week study period
Title
Changes in sleep efficiency
Description
Is calculated based on the participant's registrations in sleep diaries and by measurements from actigraphs.
Time Frame
Is measured daily during the 6 week study period.
Title
Changes in sleep latency
Description
Is calculated based on the participant's registrations in sleep diaries and by measurements from actigraphs.
Time Frame
Is measured daily during the 6 week study period
Title
Changes in sleep nocturnal awakenings
Description
Is calculated based on the participant's registrations in sleep diaries and by measurements from actigraphs.
Time Frame
Is measured daily during the 6 week study period.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 years F31 Bipolar disorder, F32 unipolar depression or F90 attention deficit disorder Insomnia Severity Index (ISI) ≥ 14 (exceeding the threshold for a sleep problem) Sleep problems for 3 months: 3 times a week at least one of the following: Sleep onset latency ≥ 30 minutes Wake after sleep onset ≥ 30 minutes Total sleep time ≥ 11 hours per day Displaced circadian rhythm; sleeps earlier than 8 P.M. or later than 02 A.M. Irregular circadian rhythm; bedtime varies ≥ 3 hours throughout the week Exclusion Criteria: Acutely increased suicide risk (Central Regions guideline for assessment of suicide risk) Active substance abuse (F10-19) The sleep problem can be significantly explained by insufficient treatment of physical disease affecting sleep (documented in patients electronic journal) Unstable social situation (does not have a permanent residence) Shift work (≥ 2 times a week for the last 2 months) Pregnancy and breast-feeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mette Kragh, PhD
Phone
9117 1262
Email
mekrag@rm.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mette Kragh
Organizational Affiliation
Department of affective disorders
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mette Kragh
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mette Kragh, PhD
Phone
+45 91171262
Email
mekrag@rm.dk
First Name & Middle Initial & Last Name & Degree
Henny Dyrberg
Phone
+45 23882553
Email
henndyrb@rm.dk

12. IPD Sharing Statement

Learn more about this trial

The Efficacy of a Transdiagnostic Sleep and Circadian Intervention for Patients With Mental Disorders and Sleep Problems

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