Clinical trial NCT05379244: Better Sleep in Psychiatric Care - Depression, Anxiety and Trauma, Pilot Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Affective Disorders
PTSD
Insomnia Chronic
Keywords: CBT-i
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2022-05-18
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment Pragmatic, within-group pilot study
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of participants registering to participate in the treatment
timeFrame: Screening
measure: Number of included participants attending the first treatment session
timeFrame: First session (1 week)
measure: Number sessions attended by the participants
timeFrame: Post-treatment (6 weeks)
measure: Number of participants dropping out of treatment
timeFrame: Post-treatment (6 weeks)
measure: Qualitative measure of group leaders' perception of the manual
timeFrame: Post-treatment (6 weeks)
Secondary outcomes:
measure: Insomnia Severity Index
timeFrame: Post-treatment (6 weeks), Three-month follow-up (21 weeks)
measure: Patient health questionnaire (PHQ-9)
timeFrame: Post-treatment (6 weeks), Three-month follow-up (21 weeks)
measure: Generalized Anxiety Disorder Assessment (GAD-7)
timeFrame: Post-treatment (6 weeks), Three-month follow-up (21 weeks)
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Program for Anxiety and Affective disorders, Stockholm Southwest Psychiatry
Study officials:
affiliation: Karolinska Institutet
name: Susanna Jernelöv, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.