Clinical trial NCT00869934: Cognitive-Behavior Therapy for Insomnia
Official title: Cognitive-Behavior Therapy for Insomnia: Component Analysis and Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Insomnia
Keywords: Insomnia
Sleep disorders
Treatment
Sleep disturbances
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: University of California, Berkeley
First posted: 2009-03-26
Enrollment: 186
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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
timeFrame: pre, post, 6- and 12-month follow ups
Secondary outcomes:
measure: psychological/psychiatric measures: severity of anxiety (STAI) and depressive symptoms (BDI); mechanism/process measures
timeFrame: pre, post, 6- and 12-month follow ups
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: University of California at Berkeley
state: California
city: Quebec City
country: Canada
facility: Laval University
state: Quebec
Study officials:
affiliation: Laval University
name: Charles M. Morin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.