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Clinical Trials/NCT04136054
NCT04136054
Active, not recruiting
Not Applicable

Better Sleep in Psychiatric Care - Depression, Anxiety and PTSD. A Randomized Naturalistic Study of a Psychological Group Treatment for Sleep Problems in Psychiatric Patients With Depression, Anxiety and PTSD.

Karolinska Institutet1 site in 1 country130 target enrollmentSeptember 25, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sleep Problem
Sponsor
Karolinska Institutet
Enrollment
130
Locations
1
Primary Endpoint
Insomnia Severity Index (ISI)
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

Cognitive Behavioral Therapy (CBT) is treatment of choice for insomnia. Many patients in psychiatric care have sleep problems including insomnia, but are rarely given the choice to participate in CBT to improve their sleep. Patients with PTSD, Anxiety disorders and Depression display high levels of sleep difficulties. Sleep problems are often general, such as insomnia and sleep phase problems. In a previous pilot study, the investigators of the current study developed a CBT protocol that would target sleep problems in this mixed psychiatric population. The basis was CBT for insomnia (CBT-i), but also including techniques that would alleviate sleep phase problems (e.g. the systematic use of light and darkness), and techniques to target more general sleep related problems (e.g. difficulties waking up in the morning), that are also common in psychiatric patients. This treatment was well tolerated and gave large withing-group effects on insomnia severity in the pilot study. In a naturalistic randomized controlled trial, the investigators now evaluate the effects of this psychological treatment on sleep and anxiety and depressive symptoms in patients at the units for Anxiety and Affective disorders and Trauma, Southwest Psychiatry and Northern Stockholm Psychiatry, Stockholm County Council, Sweden.

Registry
clinicaltrials.gov
Start Date
September 25, 2019
End Date
June 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Susanna Jernelöv

Principal Investigator

Karolinska Institutet

Eligibility Criteria

Inclusion Criteria

  • Being a patient at the clinics involved in the project
  • Experiencing sleep problems (subjective report)
  • Being able to participate in a psychological intervention in group format

Exclusion Criteria

  • Night shift work

Outcomes

Primary Outcomes

Insomnia Severity Index (ISI)

Time Frame: Changes from base-line to 8 weeks, 5 months and 14 months

7-item, self-rated questionnaire measuring insomnia severity. Total score 0-28, higher score indicates more severe sleep problems.

Secondary Outcomes

  • Patient Health Questionnaire (PHQ-9)(Changes from base-line to 8 weeks, 5 months and 14 months)
  • Generalized Anxiety Disorder 7-item scale (GAD-7)(Changes from base-line to 8 weeks, 5 months and 14 months)
  • Sleep habits and behaviors(Changes from base-line to 8 weeks, 5 months and 14 months)
  • Actigraphy(Changes from base-line to post 8 weeks)
  • Daytime Insomnia Symptoms(Changes from base-line to 8 weeks, 5 months and 14 months)
  • WHO Disability Assessment Schedule (WHODAS)(Changes from base-line to 8 weeks, 5 months and 14 months)

Study Sites (1)

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