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

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

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.

Study Overview

• Status: Completed
• Conditions: PTSD; Anxiety Disorders; Affective Disorders; Insomnia Chronic
• Intervention / Treatment: Behavioral: CBT-i

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 141 86
    • Program for Anxiety and Affective disorders, Stockholm Southwest Psychiatry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Region Stockholm

Publications and helpful links

General Publications

• Cassel M, Blom K, Gatzacis J, Renblad P, Kaldo V, Jernelov S. Clinical feasibility of cognitive behavioural therapy for insomnia in a real-world mixed sample at a specialized psychiatric outpatient clinic. BMC Psychiatry. 2022 Sep 9;22(1):600. doi: 10.1186/s12888-022-04231-4.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): October 1, 2019
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: May 10, 2022
• First Submitted That Met QC Criteria: May 13, 2022
• First Posted (Actual): May 18, 2022

Study Record Updates

• Last Update Posted (Actual): June 10, 2022
• Last Update Submitted That Met QC Criteria: June 9, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: CBT-i
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Sleep Initiation and Maintenance Disorders; Anxiety Disorders; Mood Disorders
• Other Study ID Numbers: 2018/80-31/1a

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No