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

NCT ID: NCT05379244

Last Updated: 2022-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2020-01-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CBT-i

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

Group Type: EXPERIMENTAL

CBT-i

Intervention Type: BEHAVIORAL

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

Interventions

CBT-i

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Stockholm

OTHER_GOV

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Susanna Jernelöv

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susanna Jernelöv, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Program for Anxiety and Affective disorders, Stockholm Southwest Psychiatry

Stockholm, , Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 36085009 (View on PubMed)

Other Identifiers

2018/80-31/1a

Identifier Type: -

Identifier Source: org_study_id