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Cognitive Behavioral Therapy for Insomnia in Euthymic Bipolar Disorder

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ClinicalTrials.gov Identifier: NCT01704352
Recruitment Status : Completed
First Posted : October 11, 2012
Last Update Posted : November 20, 2018
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Insomnia Behavioral: Cognitive behavioral therapy for insomnia Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cognitive Behavioral Therapy for Insomnia in Euthymic Bipolar Disorder: a Randomized Controlled Trial
Actual Study Start Date : January 2013
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arm Intervention/treatment
Active Comparator: CBT-I
Cognitive behavioral therapy for insomnia (CBT-I) is a multicomponent treatment consisting of sleep restriction therapy, psychoeducation about sleep, stimulus control, stabilizing circadian rhythm and challenging beliefs and perception of sleep.
Behavioral: Cognitive behavioral therapy for insomnia
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.

No Intervention: Treatment as usual
Treatment as usual (TAU) consists of pharmacological and supportive psychosocial treatment according to the needs of the patient.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01704352


Locations
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Norway
Østmarka Psychiatric Department, St Olavs Hospital
Trondheim, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
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Study Director: Gunnar Morken, PhD Prof Norwegian University of Science and Technology

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01704352     History of Changes
Other Study ID Numbers: 2012/1033
First Posted: October 11, 2012    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018
Keywords provided by Norwegian University of Science and Technology:
Cognitive Behavioral Therapy
CBT-I
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Bipolar Disorder
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Bipolar and Related Disorders