Clinical trial NCT04136054: Better Sleep in Psychiatric Care - Depression, Anxiety and PTSD
Official title: 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.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Sleep Problem
Anxiety Disorders
Affective Disorder
Keywords: Cognitive Behaviour Therapy
Psychological Intervention
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2019-10-23
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: Changes from base-line to 8 weeks, 5 months and 14 months
Secondary outcomes:
measure: Actigraphy
timeFrame: Changes from base-line to post 8 weeks
measure: WHO Disability Assessment Schedule (WHODAS)
timeFrame: Changes from base-line to 8 weeks, 5 months and 14 months
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Changes from base-line to 8 weeks, 5 months and 14 months
measure: Generalized Anxiety Disorder 7-item scale (GAD-7)
timeFrame: Changes from base-line to 8 weeks, 5 months and 14 months
measure: Sleep habits and behaviors
timeFrame: Changes from base-line to 8 weeks, 5 months and 14 months
measure: Daytime Insomnia Symptoms
timeFrame: Changes from base-line to 8 weeks, 5 months and 14 months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Program for Affective disorders, Anxiety and Trauma, 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.