Chronic InsomniaPhase 4NCT00869934
Cognitive-Behavior Therapy for Insomnia
A Phase 4 study testing Cognitive-Behavior Therapy, Behavior Therapy and Cognitive Therapy in people with Chronic Insomnia, run by Laval University at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Chronic Insomnia
- What is being tested?
- Cognitive-Behavior Therapy, Behavior Therapy and Cognitive Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Apr 2008to Jun 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 25 years old or older
- Chronic insomnia(> 6 months)
- 3 nights or more per week with difficulties falling or staying asleep
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
University of California at Berkeley
Berkeley, California, 94704
About this study
Official title: Cognitive-Behavior Therapy for Insomnia: Component Analysis and Treatment
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.
- Conditions
- Chronic Insomnia
- Being tested
- Cognitive-Behavior Therapy, Behavior Therapy, Cognitive Therapy
- Keywords
- Insomnia, Sleep disorders, Treatment, Sleep disturbances
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Sleep Wake Disorders, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-Behavior TherapyOther
Sleep restriction, stimulus control, cognitive therapy
Behavior TherapyOther
Sleep restriction and stimulus control
Cognitive TherapyOther
Cognitive restructuring therapy
| Study group | Role | What they receive |
|---|---|---|
| 1. Cognitive-Behavior Therapy | Active comparator | Not described Receives: Other: Cognitive-Behavior Therapy |
| 2. Behavior Therapy | Experimental | Not described Receives: Other: Behavior Therapy |
| 3. Cognitive Therapy | Experimental | Not described Receives: Other: Cognitive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: pre, post, 6- and 12-month follow ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2009 (estimated)
- Study startApr 2008
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Berkeley
- Responsible party
- Principal investigator, Charles M. Morin, Laval University
- Investigators
- Charles M. Morin, PhD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00869934
- Sponsor's protocol ID
- R01MH079188-02
- Other IDs
- NIMH
- Status last verified
- Jun 2013
- First submitted
- 24 Mar 2009
- Last updated
- 2 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 36821333Dong 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.
PubMed 29265834Belanger 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.
PubMed 26963600Eidelman 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.
PubMed 26763501
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive-Behavior Therapy for Insomnia: Component Analysis and Treatment
- ClinicalTrials.gov ID
- NCT00869934
- Acronym / sponsor ID
- R01MH079188-02
- Conditions
- Chronic Insomnia
- Keywords
- Insomnia, Sleep disorders, Treatment, Sleep disturbances
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- University of California, Berkeley
- Study start
- Apr 2008
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 26 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1. Cognitive-Behavior Therapy | Active comparator | Other: Cognitive-Behavior Therapy |
| 2. Behavior Therapy | Experimental | Other: Behavior Therapy |
| 3. Cognitive Therapy | Experimental | Other: Cognitive Therapy |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 25 years old or older
- Chronic insomnia(> 6 months)
- 3 nights or more per week with difficulties falling or staying asleep
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-Behavior TherapySleep restriction, stimulus control, cognitive therapy | Other | 1. Cognitive-Behavior Therapy |
| Behavior TherapySleep restriction and stimulus control | Other | 2. Behavior Therapy |
| Cognitive TherapyCognitive restructuring therapy | Other | 3. Cognitive Therapy |
Primary outcome
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
1 secondary outcome
psychological/psychiatric measures: severity of anxiety (STAI) and depressive symptoms (BDI); mechanism/process measures
Time frame: pre, post, 6- and 12-month follow ups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2013.
- Derived from this study: PubMed 36821333Sarfan 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.
- Derived from this study: PubMed 29265834Dong 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.
- Derived from this study: PubMed 26963600Belanger 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.
- Derived from this study: PubMed 26763501Eidelman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles M. Morin, PhD principal investigator
Laval University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cognitive-Behavior Therapy, Behavior Therapy and Cognitive Therapy in people with Chronic Insomnia, run by Laval University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: pre, post, 6- and 12-month follow ups). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00869934, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2013.