Better Sleep in Psychiatric Care - Depression, Anxiety and PTSD

NCT04136054 | Active Not Recruiting

• 1 other identifier: 2018/80-31/1.1
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Problem; Anxiety Disorders; Affective Disorder

Keywords

Cognitive Behaviour Therapy; Psychological Intervention

Outcome Measures

Primary Outcomes (1)

• Insomnia Severity Index (ISI)

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

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

Secondary Outcomes (6)

• Actigraphy

  Changes from base-line to post 8 weeks

• WHO Disability Assessment Schedule (WHODAS)

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

• 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

Study Arms (2)

Adjusted group CBT-i for Depression, Anxiety and PTSD

EXPERIMENTAL

Cognitive Behavioral group intervention for sleep problems in patients with Depression, Anxiety and PTSD, based on Cognitive Behavioral Therapy for insomnia

Behavioral: Adjusted group CBT-i for Depression, Anxiety and PTSD

Care as usual wait-list control group

ACTIVE COMPARATOR

Treatment as Usual. (After about five months, participants in this condition are offered the experimental group treatment.)

Other: Care as usual wait-list control group

Interventions

Adjusted group CBT-i for Depression, Anxiety and PTSD BEHAVIORAL

Adjusted group CBT-i for Depression, Anxiety and PTSD. CBT-i includes sleep scheduling/sleep compression, stimulus control, relaxation, cognitive interventions and sleep hygiene advice. Adjustments include the relationship between sleep and the psychiatric conditions at hand and and working with motivational enhancement techniques to increase adherence to treatment.

Adjusted group CBT-i for Depression, Anxiety and PTSD

Care as usual wait-list control group OTHER

Usual care at the clinic. This entails managing pharmacological treatment for the psychiatric problems and/or sleep problems. The clinic also provides different group treatments, such as mindfulness groups and CBT groups for symptoms of worry and depression, and individual therapy.

Care as usual wait-list control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Night shift work

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Study Sites (1)

Program for Affective disorders, Anxiety and Trauma, Stockholm Southwest Psychiatry

Stockholm, 141 86, Sweden

Location

Related Publications (1)

• 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.

  PMID: 36085009 BACKGROUND

MeSH Terms

Conditions

Parasomnias; Anxiety Disorders; Mood Disorders

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Susanna Jernelöv, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 21, 2019
• First Posted: October 23, 2019
• Study Start: September 25, 2019
• Primary Completion: November 1, 2024
• Study Completion: June 1, 2025
• Last Updated: August 12, 2024

Record last verified: 2024-08

Locations

SE (1)