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

Primary Purpose

Anxiety Disorders, Affective Disorders, PTSD

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
CBT-i
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring CBT-i

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Program for Anxiety and Affective disorders, Stockholm Southwest Psychiatry

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CBT-i

Arm Description

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

Outcomes

Primary Outcome Measures

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)
Number of included participants attending the first treatment session
At least half of included patients should attend the first treatment session
Number sessions attended by the participants
Average number of sessions attended should be no less than 3
Number of participants dropping out of treatment
Less than half of the patients should drop out of treatment
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

Secondary Outcome Measures

Insomnia Severity Index
7-item self-reported measure of insomnia severity, 0-28 points, lower is better.
Patient health questionnaire (PHQ-9)
9-item depression inventory, 0-27 points, lower is better
Generalized Anxiety Disorder Assessment (GAD-7)
7-item anxiety inventory, 0-21 points, lower is better

Full Information

First Posted
May 10, 2022
Last Updated
June 9, 2022
Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
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1. Study Identification

Unique Protocol Identification Number
NCT05379244
Brief Title
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

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
January 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Region Stockholm

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders, Affective Disorders, PTSD, Insomnia Chronic
Keywords
CBT-i

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Group Assignment Pragmatic, within-group pilot study
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBT-i
Arm Type
Experimental
Arm Description
Cognitive Behavioral Therapy for insomnia adjusted for patients with mixed psychiatric disorders
Intervention Type
Behavioral
Intervention Name(s)
CBT-i
Intervention Description
Behavioral intervention based on Cognitive Behavioral Therapy for insomnia, adjusted for psychiatric patients with anxiety disorders, affective disorders and trauma
Primary Outcome Measure Information:
Title
Number of participants registering to participate in the treatment
Description
Influx of patients should be sufficient to start at least one group per semester (at least 8 patients)
Time Frame
Screening
Title
Number of included participants attending the first treatment session
Description
At least half of included patients should attend the first treatment session
Time Frame
First session (1 week)
Title
Number sessions attended by the participants
Description
Average number of sessions attended should be no less than 3
Time Frame
Post-treatment (6 weeks)
Title
Number of participants dropping out of treatment
Description
Less than half of the patients should drop out of treatment
Time Frame
Post-treatment (6 weeks)
Title
Qualitative measure of group leaders' perception of the manual
Description
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
Time Frame
Post-treatment (6 weeks)
Secondary Outcome Measure Information:
Title
Insomnia Severity Index
Description
7-item self-reported measure of insomnia severity, 0-28 points, lower is better.
Time Frame
Post-treatment (6 weeks), Three-month follow-up (21 weeks)
Title
Patient health questionnaire (PHQ-9)
Description
9-item depression inventory, 0-27 points, lower is better
Time Frame
Post-treatment (6 weeks), Three-month follow-up (21 weeks)
Title
Generalized Anxiety Disorder Assessment (GAD-7)
Description
7-item anxiety inventory, 0-21 points, lower is better
Time Frame
Post-treatment (6 weeks), Three-month follow-up (21 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanna Jernelöv, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Program for Anxiety and Affective disorders, Stockholm Southwest Psychiatry
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36085009
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.
Results Reference
derived

Learn more about this trial

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

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