Cognitive-Behavior Therapy for Insomnia

Phase 4

Completed

• Conditions: Chronic Insomnia
• Interventions: Other: Cognitive-Behavior Therapy; Other: Behavior Therapy; Other: Cognitive Therapy

• Registration Number: NCT00869934
• Lead Sponsor: Laval University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2009-03-24
• Study First Submitted QC: 2009-03-24
• Study First Posted: 2009-03-26
• Status Verified: 2013-06
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Last Update Submitted: 2013-06-28
• Last Update Posted: 2013-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 186

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1. Cognitive-Behavior Therapy	Cognitive-Behavior Therapy	-
2. Behavior Therapy	Behavior Therapy	-
3. Cognitive Therapy	Cognitive Therapy	-

Primary Outcome Measures

Name	Time	Method
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	pre, post, 6- and 12-month follow ups

Secondary Outcome Measures

Name	Time	Method
psychological/psychiatric measures: severity of anxiety (STAI) and depressive symptoms (BDI); mechanism/process measures	pre, post, 6- and 12-month follow ups

Trial Locations

Locations (2)

University of California at Berkeley; 🇺🇸 Berkeley, California, United States

Laval University; 🇨🇦 Quebec City, Quebec, Canada