NCT00869934

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
186

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2008

Longer than P75 for phase_4

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 26, 2009

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

July 2, 2013

Status Verified

June 1, 2013

Enrollment Period

5.2 years

First QC Date

March 24, 2009

Last Update Submit

June 28, 2013

Conditions

Chronic Insomnia

Keywords

InsomniaSleep disordersTreatmentSleep disturbances

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    pre, post, 6- and 12-month follow ups

Study Arms (3)

1. Cognitive-Behavior Therapy

ACTIVE COMPARATOR
Other: Cognitive-Behavior Therapy

2. Behavior Therapy

EXPERIMENTAL
Other: Behavior Therapy

3. Cognitive Therapy

EXPERIMENTAL
Other: Cognitive Therapy

Interventions

Cognitive-Behavior TherapyOTHER

Sleep restriction, stimulus control, cognitive therapy

1. Cognitive-Behavior Therapy
Behavior TherapyOTHER

Sleep restriction and stimulus control

2. Behavior Therapy
Cognitive TherapyOTHER

Cognitive restructuring therapy

3. Cognitive Therapy

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California at Berkeley

Berkeley, California, 94704, United States

Location

Laval University

Québec, Quebec, G1K 0A6, Canada

Location

Related Publications (4)

  • Sarfan LD, Morin CM, Harvey AG. Twelve-month follow-up: Comparative efficacy of cognitive therapy, behavior therapy, and cognitive behavior therapy for patients with insomnia. J Consult Clin Psychol. 2023 Oct;91(10):606-613. doi: 10.1037/ccp0000802. Epub 2023 Feb 23.

    PMID: 36821333DERIVED

  • 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.

    PMID: 29265834DERIVED

  • 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.

    PMID: 26963600DERIVED

  • 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.

    PMID: 26763501DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersSleep Wake DisordersParasomnias

Interventions

Cognitive Behavioral TherapyBehavior Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasNervous System DiseasesMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Charles M. Morin, PhD

    Laval University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professeur

Study Record Dates

First Submitted

March 24, 2009

First Posted

March 26, 2009

Study Start

April 1, 2008

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

July 2, 2013

Record last verified: 2013-06

Locations

US(1)CA(1)