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Better Sleep in Psychiatric Care - Anxiety and Affective Disorders (BSIP-AAD)

Primary Purpose

Sleep Problem, Anxiety Disorders, Affective Disorder

Status
Active
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Adjusted group CBT-i for Anxiety and Affective disorders
Care as usual wait-list control group
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Problem focused on measuring Cognitive Behaviour Therapy, Psychological Intervention

Eligibility Criteria

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

Inclusion Criteria:

  • Being a patient at the clinics involved in the project
  • Experiencing sleep problems (subjective report)
  • Being able to participate in a psychological intervention in group format

Exclusion Criteria:

  • Night shift work

Sites / Locations

  • Program for Anxiety and Affective disorders, Stockholm Southwest Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Adjusted group CBT-i for Anxiety and Affective disorders

Care as usual wait-list control group

Arm Description

Cognitive Behavioral group intervention for sleep problems in patients with Anxiety and Affective disorders, based on Cognitive Behavioral Therapy for insomnia

Treatment as Usual. (After about five months, participants in this condition are offered the experimental group treatment.)

Outcomes

Primary Outcome Measures

Insomnia Severity Index (ISI)
7-item, self-rated questionnaire measuring insomnia severity. Total score 0-28, higher score indicates more severe sleep problems.

Secondary Outcome Measures

Actigraphy
An actigraph is placed on the participant's arm for one week. It measures participants' arm-movements. An algorithm can be used to estimate sleep from movement data.
WHO Disability Assessment Schedule (WHODAS)
12-items self-rating questionnaire measuring disability. Total score (0-48), with higher score indicating more severe disability.
Patient Health Questionnaire (PHQ-9)
9-items self-rating questionnaire measuring level of depression. Total score 0-27 with higher score indicating more severe depression
Generalized Anxiety Disorder 7-item scale (GAD-7)
7-item self-rating questionnaire measuring level of anxiety. Total score 0-21 with higher score indicating more severe anxiety.
Sleep habits and behaviors
Self-rating questionnaire regarding the use of sleep promoting behaviors. The questionnaire was constructed for the larger BSIP project and consists of two parts. The first part includes statements such as "Last week I got out of bed within 15 minutes of waking up" to be answered by number of days the last week this was true (i.e. from 0 to 7). The second part is to be answered on a 6-point Likert scale from "Not at all true" to "Entirely true", with 7 statements like "I get out of bed the same time every morning". No total score is obtained.
Daytime Insomnia Symptoms
7-item self-rating questionnaire regarding daytime symptoms commonly associated with sleep problems. Total score 0-70, with higher score indicating more severe daytime symptoms.

Full Information

First Posted
October 21, 2019
Last Updated
October 2, 2023
Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
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1. Study Identification

Unique Protocol Identification Number
NCT04136054
Brief Title
Better Sleep in Psychiatric Care - Anxiety and Affective Disorders
Acronym
BSIP-AAD
Official Title
Better Sleep in Psychiatric Care - Anxiety and Affective Disorders. A Randomized Naturalistic Study of a Psychological Group Treatment for Sleep Problems in Psychiatric Patients With Anxiety and Affective Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 25, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Region Stockholm

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
Cognitive Behavioral Therapy (CBT) is treatment of choice for insomnia. Many patients in psychiatric care have sleep problems including insomnia, but are rarely given the choice to participate in CBT to improve their sleep. Patients with Anxiety disorders and Affective disorders display high levels of sleep difficulties. Sleep problems are often general, such as insomnia and sleep phase problems. In a previous pilot study, the investigators of the current study developed a CBT protocol that would target sleep problems in this population. The basis was CBT for insomnia (CBT-i), but also including techniques that would alleviate sleep phase problems, (e.g. the systematic use of light and darkness), and techniques to target more general sleep related problems (e.g. difficulties waking up in the morning), that are also common in psychiatric patients. This treatment was well tolerated and gave moderate effects on insomnia severity in the pilot study. In a naturalistic randomized controlled trial, the investigators now evaluate the effects of this psychological treatment on sleep and anxiety and affective symptoms in patients at the program for Anxiety and Affective disorders, Southwest Psychiatry, Stockholm County Council, Sweden.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Problem, Anxiety Disorders, Affective Disorder
Keywords
Cognitive Behaviour Therapy, Psychological Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adjusted group CBT-i for Anxiety and Affective disorders
Arm Type
Experimental
Arm Description
Cognitive Behavioral group intervention for sleep problems in patients with Anxiety and Affective disorders, based on Cognitive Behavioral Therapy for insomnia
Arm Title
Care as usual wait-list control group
Arm Type
Active Comparator
Arm Description
Treatment as Usual. (After about five months, participants in this condition are offered the experimental group treatment.)
Intervention Type
Behavioral
Intervention Name(s)
Adjusted group CBT-i for Anxiety and Affective disorders
Intervention Description
Adjusted group CBT-i for Anxiety and Affective disorders. CBT-i includes sleep scheduling/sleep compression, stimulus control, relaxation, cognitive interventions and sleep hygiene advice. Adjustments include the relationship between sleep and the psychiatric conditions at hand and and working with motivational enhancement techniques to increase adherence to treatment.
Intervention Type
Other
Intervention Name(s)
Care as usual wait-list control group
Intervention Description
Usual care at the clinic. This entails managing pharmacological treatment for the psychiatric problems and/or sleep problems. The clinic also provides different group treatments, for instance mindfulness groups and CBT groups for symptoms of worry and depression, and individual therapy.
Primary Outcome Measure Information:
Title
Insomnia Severity Index (ISI)
Description
7-item, self-rated questionnaire measuring insomnia severity. Total score 0-28, higher score indicates more severe sleep problems.
Time Frame
Changes from base-line to 8 weeks, 5 months and 14 months
Secondary Outcome Measure Information:
Title
Actigraphy
Description
An actigraph is placed on the participant's arm for one week. It measures participants' arm-movements. An algorithm can be used to estimate sleep from movement data.
Time Frame
Changes from base-line to post 8 weeks
Title
WHO Disability Assessment Schedule (WHODAS)
Description
12-items self-rating questionnaire measuring disability. Total score (0-48), with higher score indicating more severe disability.
Time Frame
Changes from base-line to 8 weeks, 5 months and 14 months
Title
Patient Health Questionnaire (PHQ-9)
Description
9-items self-rating questionnaire measuring level of depression. Total score 0-27 with higher score indicating more severe depression
Time Frame
Changes from base-line to 8 weeks, 5 months and 14 months
Title
Generalized Anxiety Disorder 7-item scale (GAD-7)
Description
7-item self-rating questionnaire measuring level of anxiety. Total score 0-21 with higher score indicating more severe anxiety.
Time Frame
Changes from base-line to 8 weeks, 5 months and 14 months
Title
Sleep habits and behaviors
Description
Self-rating questionnaire regarding the use of sleep promoting behaviors. The questionnaire was constructed for the larger BSIP project and consists of two parts. The first part includes statements such as "Last week I got out of bed within 15 minutes of waking up" to be answered by number of days the last week this was true (i.e. from 0 to 7). The second part is to be answered on a 6-point Likert scale from "Not at all true" to "Entirely true", with 7 statements like "I get out of bed the same time every morning". No total score is obtained.
Time Frame
Changes from base-line to 8 weeks, 5 months and 14 months
Title
Daytime Insomnia Symptoms
Description
7-item self-rating questionnaire regarding daytime symptoms commonly associated with sleep problems. Total score 0-70, with higher score indicating more severe daytime symptoms.
Time Frame
Changes from base-line to 8 weeks, 5 months and 14 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Being a patient at the clinics involved in the project Experiencing sleep problems (subjective report) Being able to participate in a psychological intervention in group format Exclusion Criteria: Night shift work
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanna Jernelöv, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Program for Anxiety and Affective disorders, Stockholm Southwest Psychiatry
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
12482465
Citation
Ohayon MM, Roth T. Place of chronic insomnia in the course of depressive and anxiety disorders. J Psychiatr Res. 2003 Jan-Feb;37(1):9-15. doi: 10.1016/s0022-3956(02)00052-3.
Results Reference
background
PubMed Identifier
25337948
Citation
Blom K, Jernelov S, Kraepelien M, Bergdahl MO, Jungmarker K, Ankartjarn L, Lindefors N, Kaldo V. Internet treatment addressing either insomnia or depression, for patients with both diagnoses: a randomized trial. Sleep. 2015 Feb 1;38(2):267-77. doi: 10.5665/sleep.4412.
Results Reference
background
PubMed Identifier
28003955
Citation
Jansson-Frojmark M, Norell-Clarke A. Cognitive Behavioural Therapy for Insomnia in Psychiatric Disorders. Curr Sleep Med Rep. 2016;2(4):233-240. doi: 10.1007/s40675-016-0055-y. Epub 2016 Oct 20.
Results Reference
background

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Better Sleep in Psychiatric Care - Anxiety and Affective Disorders

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