Better Sleep in Psychiatric Care - Depression, Anxiety and Trauma, Pilot Study

Study Overview
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Brief Summary
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Between 50-80 percent of patients in psychiatry have insomnia-type sleep problems. In addition to reduced quality of life and impaired function, sleep problems can aggravate other psychiatric problems and increase the risk of relapse into, for example, depression. According to international guidelines, cognitive behavioral therapy for insomnia (CBT-i) should be used as the first choice for treatment of insomnia. In practice, however, it is very uncommon for psychiatric patients to be offered CBT-i, instead most are treated with sleep medications. There is also a lack of research studies evaluating CBT-i in regular clinical practice. This pilot study investigated the feasibility of a group treatment with CBT-i at a psychiatric outpatient clinic in Stockholm for patients with depression, bipolar disorder II, anxiety syndrome and PTSD. Changes in symptoms of insomnia, depression, and anxiety after treatment were also investigated. Patients with self-perceived sleep problems were offered a six-session group treatment based on CBT-i. The primary outcome was clinical feasibility, defined as: the influx of patients sufficient to start at least one group per semester (at least 8 patients); at least half of included patients participate in the first session; patients participate in at least half of the sessions; less than half of the patients drop out of treatment; group leaders find the treatment manual credible, easy to use and want to continue working with it after the study is completed. Secondary outcomes were changes in insomnia symptoms, and changes in symptoms of depression and anxiety.

Official Title
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Better Sleep in Psychiatric Care - Clinical Feasibility and Preliminary Effects of CBT for Insomnia in a Mixed Psychiatric Sample at an Outpatient Clinic

Conditions
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Anxiety Disorders, Affective Disorders, PTSD, Insomnia Chronic

Intervention / Treatment
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* Behavioral: CBT-i


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being a patient at a specialist outpatient clinic treating these patient groups Insomnia disorder or sleep problems of insomnia type Over 10 points on the Insomnia Severity Index (ISI) Adequate skills in written and spoken Swedish No practical barriers to participate in the group treatment Exclusion Criteria: night shift work ongoing alcohol or drug abuse that required treatment at a specialised unit

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single Group Assignment Pragmatic, within-group pilot study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT-i<br>Cognitive Behavioral Therapy for insomnia adjusted for patients with mixed psychiatric disorders | Behavioral: CBT-i<br>* Behavioral intervention based on Cognitive Behavioral Therapy for insomnia, adjusted for psychiatric patients with anxiety disorders, affective disorders and trauma<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants registering to participate in the treatment | Influx of patients should be sufficient to start at least one group per semester (at least 8 patients) | Screening | 
| Number of included participants attending the first treatment session | At least half of included patients should attend the first treatment session | First session (1 week) | 
| Number sessions attended by the participants | Average number of sessions attended should be no less than 3 | Post-treatment (6 weeks) | 
| Number of participants dropping out of treatment | Less than half of the patients should drop out of treatment | Post-treatment (6 weeks) | 
| Qualitative measure of group leaders' perception of the manual | Group leaders should find the treatment manual credible and easy to use, and be willing to continue using the treatment manual after the study is completed | Post-treatment (6 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Severity Index | 7-item self-reported measure of insomnia severity, 0-28 points, lower is better. | Post-treatment (6 weeks), Three-month follow-up (21 weeks) | 
| Patient health questionnaire (PHQ-9) | 9-item depression inventory, 0-27 points, lower is better | Post-treatment (6 weeks), Three-month follow-up (21 weeks) | 
| Generalized Anxiety Disorder Assessment (GAD-7) | 7-item anxiety inventory, 0-21 points, lower is better | Post-treatment (6 weeks), Three-month follow-up (21 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CBT-i