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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05379244
Other study ID # 2018/80-31/1a
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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