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

Not Applicable

Completed

• Conditions: Anxiety Disorders; Affective Disorders; PTSD; Insomnia Chronic
• Interventions: Behavioral: CBT-i

• Registration Number: NCT05379244
• Lead Sponsor: Karolinska Institutet

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2019-10-01
• Study Completion: 2020-01-31
• Study First Submitted: 2022-05-10
• Study First Submitted QC: 2022-05-13
• Study First Posted: 2022-05-18
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-09
• Last Update Posted: 2022-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CBT-i	CBT-i	Cognitive Behavioral Therapy for insomnia adjusted for patients with mixed psychiatric disorders

Primary Outcome Measures

Name	Time	Method
Number sessions attended by the participants	Post-treatment (6 weeks)	Average number of sessions attended should be no less than 3
Number of participants dropping out of treatment	Post-treatment (6 weeks)	Less than half of the patients should drop out of treatment
Number of participants registering to participate in the treatment	Screening	Influx of patients should be sufficient to start at least one group per semester (at least 8 patients)
Qualitative measure of group leaders' perception of the manual	Post-treatment (6 weeks)	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
Number of included participants attending the first treatment session	First session (1 week)	At least half of included patients should attend the first treatment session

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Program for Anxiety and Affective disorders, Stockholm Southwest Psychiatry; 🇸🇪 Stockholm, Sweden