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Completed

NCT Number: NCT04130529

Better Sleep in Psychiatric Care - Bipolar

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 Bipolar disorder is a patient group with high levels of sleep difficulties. Sleep problems in this patient group can be both more general such as insomnia, but can also be related to the Bipolar disorder. Other research groups have studied the use of behaviorally sleep treatments in patients with Bipolar disorder, but more studies are needed. In a previous pilot study, the investigators of the current study developed a CBT protocol that would target sleep problems in this population. The basis was CBT for insomnia (CBT-i), but with more emphasis on achieving sleep promoting behaviors specific to Bipolar patients, for instance techniques that would also 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 patients with Bipolar disorder. This treatment was well tolerated and gave moderate 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 Bipolar symptoms in patients at the departments of Affective disorders, Northern Stockholm Psychiatry and Southwest Psychiatry, Stockholm, Sweden.

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Key information

Conditions

Sleep Problem Bipolar Disorder Bipolar and Related 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

Department of Affective Disorders, Northern Stockholm Psychiatry, Stockholm, Stockholm County, Sweden

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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 Bipolar disorder

Behavioral

CBT-i includes sleep scheduling/sleep compression, stimulus control, relaxation, cognitive interventions and sleep hygiene advice. In addition components targeting circadian rhythm problems and problems with very high or very low levels of activity are included.

Sleep lectures

Other

Lectures on the topic of sleep.

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 change in insomnia severity. Total score 0-28, higher score indicates more severe sleep problems.

Secondary outcomes

  1. 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.

  2. Affective Self Rating Scale (AS-18)

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

    18-items self-report questionnaire measuring bipolar symptoms. Total score 0-72, subscale for depression (0-36), subscale for mania (0-36). Higher score indicates more severe symptoms.

  3. 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 other 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.

  4. 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.

  5. 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.

  6. Sleep diary

    Time frame: Two weeks pre-treatment, two weeks post-treatment

    Sleep diary based on the Core Consensus Sleep Diary. Participants report bedtime, sleep onset attempts, sleep onset latency, number and duration of nocturnal awakenings, wake-up time, rise time, and sleep quality (1-5). Two items from the Expanded Consensus Sleep Diary added, assessing sleep medication use during the night and level of morning refreshment/recovery (1-5). Diary to be completed each morning.

Other outcomes

  1. CSQ-8

    Time frame: Week 8 of treatment (i.e. post-treatment)

    Treatment satisfaction assessed post-treatment using the Client Satisfaction Questionnaire (CSQ-8), an eight-item self-report measure with total scores ranging from 8 to 32, where higher scores indicate greater satisfaction.

  2. Side-effects

    Time frame: Week 8 of treatment (i.e. post-treatment)

    Side effects were assessed using a self-report checklist of 12 common side effects. Participants indicated whether each side effect was present and rated its interference with functioning on a 0-4 scale. Additional side effects could be reported and rated using the same scale.

  3. Adverse events

    Time frame: Start of treatment until end of treatment (8 weeks)

    Adverse events, including clinically significant mood deterioration and major negative events (eg, hospitalisation), were reported by therapists throughout treatment.

  4. TCS

    Time frame: Week 3 of treatment

    Treatment credibility assessed using a five-item self-report scale adapted from the Credibility/Expectancy Questionnaire and Borkovec & Nau (total score 5-50; higher scores indicate greater credibility).

  5. Need for additional care

    Time frame: Three-month follow-up

    Participants reported their need for additional sleep-related care, whether they intended to seek treatment, and what type of treatment they preferred.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Region Stockholm

Registry information

Official study title

Better Sleep in Psychiatric Care - Bipolar. A Randomized Naturalistic Study of a Psychological Group Treatment for Sleep Problems in Psychiatric Patients With Bipolar Disorder

Acronym: BSIP-Bipolar

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Oct 17, 2019
Registry last updated
Jul 10, 2026

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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