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NCT Number: NCT04136054

Better Sleep in Psychiatric Care - Depression, Anxiety and PTSD

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Sleep Problem Affective Disorder Anxiety Disorders Mental Disorders Mood Disorders Nervous System Diseases Parasomnias Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Stockholm, 141 86, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  1. Actigraphy

    Time frame: Changes from base-line to post 8 weeks

    An actigraph is placed on the participant's arm for one week. It measures participants' arm-movements. An algorithm can be used to estimate sleep from movement data.

  2. WHO Disability Assessment Schedule (WHODAS)

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

    12-items self-rating questionnaire measuring disability. Total score (0-48), with higher score indicating more severe disability.

  3. Patient Health Questionnaire (PHQ-9)

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

    9-items self-rating questionnaire measuring level of depression. Total score 0-27 with higher score indicating more severe depression

  4. Generalized Anxiety Disorder 7-item scale (GAD-7)

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

    7-item self-rating questionnaire measuring level of anxiety. Total score 0-21 with higher score indicating more severe anxiety.

  5. Sleep habits and behaviors

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

    Self-rating questionnaire regarding the use of sleep promoting behaviors. The questionnaire was constructed for the larger BSIP project and consists of two parts. The first part includes statements such as "Last week I got out of bed within 15 minutes of waking up" to be answered by number of days the last week this was true (i.e. from 0 to 7). The second part is to be answered on a 6-point Likert scale from "Not at all true" to "Entirely true", with 7 statements like "I get out of bed the same time every morning". No total score is obtained.

  6. Daytime Insomnia Symptoms

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

    7-item self-rating questionnaire regarding daytime symptoms commonly associated with sleep problems. Total score 0-70, with higher score indicating more severe daytime symptoms.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Region Stockholm

Registry information

Official study 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.

Acronym: BSIP-DAP

Important dates

Study start
2019
Primary completion
2024
Study completion
2025
First posted
Oct 23, 2019
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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