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Completed

NCT Number: NCT01704352

Cognitive Behavioral Therapy for Insomnia in Euthymic Bipolar Disorder

Patients with bipolar disorder suffer from sleep disturbances, even in euthymic phases. Changes in sleep are frequent signs of a new episode of (hypo)mania or depression. Cognitive behavioral therapy for insomnia is an effective treatment for primary insomnia, but has not been introduced to patients with bipolar disorder. The aim is to compare cognitive behavioral therapy added to 'treatment as usual' with just 'treatment as usual'. The investigators hypothesize that cognitive behavioral therapy will improve quality of sleep, stabilize minor mood variations and prevent new mood episodes in euthymic patients with bipolar disorder and insomnia.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Dyssomnias Insomnia Mental Disorders Mood Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Østmarka Psychiatric Department, St Olavs Hospital

Trondheim, Norway

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Fulfilling criteria for SCID-1-verified bipolar I or II disorder
  • Euthymic, as defined by Montgomery Åsberg Depression Rating Scale (MADRS) not higher than eleven, and Young Mania Rating scale (YMRS) not higher than five.
  • Fulfilling DSM-IV criteria for primary insomnia or insomnia related to another mental disorder, as assessed by the Insomnia Interview Schedule (IIS).

Exclusion criteria

  • Being or having been in a defined affective episode the last month before inclusion
  • Hospitalization in the last two months before inclusion
  • Working night shifts
  • Sleep apnea
  • Medical conditions incompatible with participation.
  • Inability to cooperate in the 3-week initial phase before randomization.

Treatment and study plan

Cognitive Behavioral Therapy for Insomnia

Behavioral

CBT-I will be given during 3-6 sessions according to need by two therapists being either psychiatrists or psychologists with clinical experience in CBT-I.

Primary outcomes

  1. Change from baseline in quality of sleep at 8 weeks

    Time frame: At 8 weeks from randomization

    As assessed by the Insomnia Severity Index (ISI)

  2. Change from baseline in quality of sleep at 6 months follow-up

    Time frame: 6 months from end of treatment phase

    As assessed by the Insomnia Severity Index (ISI)

Secondary outcomes

  1. Variation in sleep registration from baseline to 8 weeks

    Time frame: At 8 weeks

    Comparing registrations of sleep by sleep diaries, actigraphs and polysomnography.

  2. Variation in sleep registration from baseline to 6 months follow-up

    Time frame: At 6 months

    Comparing registrations of sleep by sleep diaries, actigraphs and polysomnography.

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • St. Olavs Hospital

Registry information

Official study title

Cognitive Behavioral Therapy for Insomnia in Euthymic Bipolar Disorder: a Randomized Controlled Trial

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Oct 11, 2012
Registry last updated
Nov 20, 2018

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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