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Cognitive-Behavior Therapy for Insomnia

Primary Purpose

Chronic Insomnia

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Cognitive-Behavior Therapy
Behavior Therapy
Cognitive Therapy
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Insomnia focused on measuring Insomnia, Sleep disorders, Treatment, Sleep disturbances

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged 25 years old or older
  • Chronic insomnia(> 6 months)
  • 3 nights or more per week with difficulties falling or staying asleep

Exclusion Criteria:

  • Progressive or unstable medical condition directly interfering with sleep
  • History of psychosis or bipolar disorder
  • Alcohol/substance abuse within the past 12 months
  • Use of medications interfering with sleep
  • Presence of another sleep disorder (e.g., sleep apnea, restless legs syndrome/periodic limb movements)
  • Irregular sleep-wake schedule

Sites / Locations

  • University of California at Berkeley
  • Laval University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

1. Cognitive-Behavior Therapy

2. Behavior Therapy

3. Cognitive Therapy

Arm Description

Outcomes

Primary Outcome Measures

Sleep/insomnia measures: sleep continuity (sleep latency, time awake after sleep onset, total sleep time); insomnia severity index; daytime functioning measures: fatigue, work/social adjustment, quality of life

Secondary Outcome Measures

psychological/psychiatric measures: severity of anxiety (STAI) and depressive symptoms (BDI); mechanism/process measures

Full Information

First Posted
March 24, 2009
Last Updated
June 28, 2013
Sponsor
Laval University
Collaborators
University of California, Berkeley
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1. Study Identification

Unique Protocol Identification Number
NCT00869934
Brief Title
Cognitive-Behavior Therapy for Insomnia
Official Title
Cognitive-Behavior Therapy for Insomnia: Component Analysis and Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University
Collaborators
University of California, Berkeley

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Insomnia is a prevalent public health problem affecting large segments of the population on an occasional, recurrent, or chronic basis. Persistent insomnia is associated with impairments in daytime functioning, reduced quality of life, and increased health-care costs. Despite evidence that cognitive-behavior therapy (CBT) is an effective and well accepted treatment for insomnia, a significant proportion of individuals do not respond adequately to this treatment. Hence, there is a need to identify the active therapy components and mechanisms of change in order to develop more effective therapeutic approaches and optimize outcomes. The specific aims of the proposed study are to (a) evaluate the effects of behavioral versus cognitive therapies for insomnia and associated daytime impairment, (b) investigate the mechanisms of change and, (c) examine the impact of insomnia therapies on psychiatric conditions commonly associated with insomnia (anxiety disorders and depression). A sample of 186 adults with chronic insomnia will be recruited from two sites (Laval University and University of California, Berkeley). Participants will be randomly assigned to one of three groups: (a) behavior therapy (BT; n = 62), (b) cognitive therapy (CT; n = 62), or (c) cognitive-behavior therapy (CBT; n = 62). Measures of outcome (sleep/insomnia, daytime functioning) will be administered at baseline, end of treatment, and at 6- and 12-month follow up. Measures of mechanisms of change (maladaptive sleep habits, unhelpful beliefs, sleep-related worry) will be administered at baseline, after the 4th and 8th therapy sessions, and at the end of treatment. It is expected that (1) BT and CBT will be more effective for improving sleep, relative to CT, (2) CT and CBT will be more effective for reducing daytime functional impairment, relative to BT and (3)CT will be more effective than BT in reducing comorbid psychiatric disorders. The public health significance of the proposed study is that it will provide useful information to improve our understanding of insomnia and to enhance efficacy and efficiency of therapeutic approaches for a prevalent and costly health problem. The long-term objective is to contribute to the development and dissemination of evidence-based treatments for chronic insomnia and its common comorbidities.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Insomnia
Keywords
Insomnia, Sleep disorders, Treatment, Sleep disturbances

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
186 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1. Cognitive-Behavior Therapy
Arm Type
Active Comparator
Arm Title
2. Behavior Therapy
Arm Type
Experimental
Arm Title
3. Cognitive Therapy
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Cognitive-Behavior Therapy
Intervention Description
Sleep restriction, stimulus control, cognitive therapy
Intervention Type
Other
Intervention Name(s)
Behavior Therapy
Intervention Description
Sleep restriction and stimulus control
Intervention Type
Other
Intervention Name(s)
Cognitive Therapy
Intervention Description
Cognitive restructuring therapy
Primary Outcome Measure Information:
Title
Sleep/insomnia measures: sleep continuity (sleep latency, time awake after sleep onset, total sleep time); insomnia severity index; daytime functioning measures: fatigue, work/social adjustment, quality of life
Time Frame
pre, post, 6- and 12-month follow ups
Secondary Outcome Measure Information:
Title
psychological/psychiatric measures: severity of anxiety (STAI) and depressive symptoms (BDI); mechanism/process measures
Time Frame
pre, post, 6- and 12-month follow ups

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 25 years old or older Chronic insomnia(> 6 months) 3 nights or more per week with difficulties falling or staying asleep Exclusion Criteria: Progressive or unstable medical condition directly interfering with sleep History of psychosis or bipolar disorder Alcohol/substance abuse within the past 12 months Use of medications interfering with sleep Presence of another sleep disorder (e.g., sleep apnea, restless legs syndrome/periodic limb movements) Irregular sleep-wake schedule
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles M. Morin, PhD
Organizational Affiliation
Laval University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California at Berkeley
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Facility Name
Laval University
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1K 0A6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
29265834
Citation
Dong L, Soehner AM, Belanger L, Morin CM, Harvey AG. Treatment agreement, adherence, and outcome in cognitive behavioral treatments for insomnia. J Consult Clin Psychol. 2018 Mar;86(3):294-299. doi: 10.1037/ccp0000269. Epub 2017 Dec 21.
Results Reference
derived
PubMed Identifier
26963600
Citation
Belanger L, Harvey AG, Fortier-Brochu E, Beaulieu-Bonneau S, Eidelman P, Talbot L, Ivers H, Hein K, Lamy M, Soehner AM, Merette C, Morin CM. Impact of comorbid anxiety and depressive disorders on treatment response to cognitive behavior therapy for insomnia. J Consult Clin Psychol. 2016 Aug;84(8):659-67. doi: 10.1037/ccp0000084. Epub 2016 Mar 10.
Results Reference
derived
PubMed Identifier
26763501
Citation
Eidelman P, Talbot L, Ivers H, Belanger L, Morin CM, Harvey AG. Change in Dysfunctional Beliefs About Sleep in Behavior Therapy, Cognitive Therapy, and Cognitive-Behavioral Therapy for Insomnia. Behav Ther. 2016 Jan;47(1):102-15. doi: 10.1016/j.beth.2015.10.002. Epub 2015 Oct 19.
Results Reference
derived

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Cognitive-Behavior Therapy for Insomnia

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