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

NCT05379244 | Completed

• 1 other identifier: 2018/80-31/1a
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorders; Affective Disorders; PTSD; Insomnia Chronic

Keywords

CBT-i

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Insomnia Severity Index

  Post-treatment (6 weeks), Three-month follow-up (21 weeks)

• Patient health questionnaire (PHQ-9)

  Post-treatment (6 weeks), Three-month follow-up (21 weeks)

• Generalized Anxiety Disorder Assessment (GAD-7)

  Post-treatment (6 weeks), Three-month follow-up (21 weeks)

Study Arms (1)

CBT-i

EXPERIMENTAL

Cognitive Behavioral Therapy for insomnia adjusted for patients with mixed psychiatric disorders

Behavioral: CBT-i

Interventions

CBT-i BEHAVIORAL

Behavioral intervention based on Cognitive Behavioral Therapy for insomnia, adjusted for psychiatric patients with anxiety disorders, affective disorders and trauma

CBT-i

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• night shift work
• ongoing alcohol or drug abuse that required treatment at a specialised unit

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Study Sites (1)

Program for Anxiety and Affective disorders, Stockholm Southwest Psychiatry

Stockholm, 141 86, Sweden

Location

Related Publications (1)

• 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.

  PMID: 36085009 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Mood Disorders; Stress Disorders, Post-Traumatic; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Susanna Jernelöv, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Single Group Assignment Pragmatic, within-group pilot study

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 18, 2022
• Study Start: January 1, 2019
• Primary Completion: October 1, 2019
• Study Completion: January 31, 2020
• Last Updated: June 10, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)