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

Anxiety Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05379244
• Other study ID #: 2018/80-31/1a
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: January 31, 2020

Study information

• Verified date: June 2022
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 31, 2020
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Affective Disorders
• Anxiety Disorders
• Disease
• Insomnia Chronic
• Mood Disorders
• PTSD
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• CBT-i
Behavioral intervention based on Cognitive Behavioral Therapy for insomnia, adjusted for psychiatric patients with anxiety disorders, affective disorders and trauma

Locations

Country	Name	City	State
Sweden	Program for Anxiety and Affective disorders, Stockholm Southwest Psychiatry	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Region Stockholm

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	Number sessions attended by the participants	Average number of sessions attended should be no less than 3	Post-treatment (6 weeks)
Primary	Number of participants dropping out of treatment	Less than half of the patients should drop out of treatment	Post-treatment (6 weeks)
Primary	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	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)
Secondary	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)
Secondary	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)