- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02774642
Integrated CBT-I and PE on Sleep and PTSD Outcomes (Impact Study)
The Impact of Integrated CBT-I and PE on Sleep and PTSD Outcomes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The lifetime prevalence of posttraumatic stress disorder (PTSD) is approximately 30% among Vietnam Veterans and 11-17% among Iraq and Afghanistan Veterans. PTSD is associated with enormous health care costs, increased suicidality, depression, poorer quality of life and functioning, physical health, and increased substance use. Prolonged exposure (PE) is an efficacious treatment for Veterans with PTSD that decreases avoidance of feared, but safe, cues. Despite PE being one of the best available treatments for PTSD, 25 to 45% of PTSD patients still meet diagnostic criteria following treatment. High rates of comorbid disorders, such as insomnia, may interfere with the efficacy of PE and limit long-term rehabilitation outcomes.
Among Veterans with PTSD, sleep disturbances are nearly universal with 70 - 87% reporting comorbid insomnia. Untreated insomnia can persist for years, is independently associated with impaired health-related quality of life, does not resolve following PTSD treatment, and can exacerbate daytime PTSD symptoms.
Importantly, insomnia may interfere with the mechanisms of PE through safety learning, habituation to feared stimuli, emotional coping, emotional processing, and cognitive abilities necessary for successful treatment.
Despite this, insomnia is not a primary intervention for Veterans with PTSD. Given these factors, it is critical to evaluate whether treating insomnia prior to PTSD will improve PTSD symptoms and quality of life outcomes. Cognitive behavioral treatment for insomnia (CBT-I) is the first line treatment of chronic and severe insomnia, which produces lasting improvements in sleep. By using CBT-I prior to, and integrated with, PE offers several novel advantages that will: 1) increase client-centered treatment by addressing the number one subjective complaint among Veterans with PTSD; 2) enhance PTSD outcomes and non-response rates by addressing insomnia-related factors that interfere with PTSD treatment; 3) act as a stepping stone and help to engage patients who are not initially willing to engage in trauma-focused PE; 4) increase rehabilitation outcomes by addressing the two leading disorders that independently affect quality of life for Veterans; 5) allow patients to address both symptoms of insomnia and PTSD within a shortened timeframe; 6) increase continuity by allowing patients to work with a single provider; and 7) decrease the risk of attrition between referral clinics and waitlists. To date, no studies have capitalized on available evidence-based CBT-I prior to PE to improve insomnia, PTSD, and quality of life outcomes.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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California
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San Diego, California, United States, 92161
- VA San Diego Healthcare System, San Diego, CA
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Over the age of 19 years old
- Diagnosis of PTSD
- Meet diagnostic criteria for insomnia
- Enrolled at the VA San Diego Healthcare System (VASDHS) and living within 50 miles of the respective facility
- English literacy
Exclusion Criteria:
- Unmanaged psychosis or manic episodes in past year
- Substance/alcohol use disorder in past 6 months
Diagnosed (previously or by the investigators' study screen) and untreated sleep disorder other than insomnia
- Sleep disorders diagnosed, but stably treated, such as obstructive sleep apnea treated with continuous positive airway pressure (CPAP), will be allowed)
Participation in concurrent psychotherapies targeting PTSD
- Veteran can be reassessed after their PTSD treatment concludes
- Veterans who are engaged in treatment for non-PTSD symptoms (e.g., 12-step programs) will be eligible
- Severe medical or psychiatric illness that would make it difficult to regularly attend psychotherapy sessions or participate fully in the study
- History of moderate to severe cognitive impairment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CBTI-PE
Integrates the core components of CBT-I and PE in 14 90-minute weekly sessions.
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Integrates CBT-I and PE with the goal of enhancing both insomnia and PTSD outcomes.
Integrated treatment will be delivered in 14 90-minute weekly sessions.
CBTI-PE starts with VA rollout CBT-I for the first 3 weeks with a focus on the effects of PTSD on insomnia.
PE protocol (psychoeducation) begins on week 4 of treatment and both treatments overlap till week 6 when CBT-I ends and the active treatment of PE begins (i.e., imaginal and in-vivo exposures).
However, CBT-I sleep diary review and sleep time adjustment will continue till the end of treatment to increase adherence
|
Active Comparator: Hygiene-PE
Uses non-active sleep hygiene to account for the dose response of experimental condition before starting PE.
Uses 14 90-minute weekly sessions.
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The investigators have included a non-active sleep control arm (3 Sessions)to allow for the dose response of 14 90 minute sessions.
The non-active sleep control condition used in this study is a manualized protocol developed to exclude the active components of standard CBT-I treatment.
Hygiene includes presentation of sleep hygiene education and reviewing daily stressors that may impact sleep before starting PE on week 4.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in PTSD Symptoms
Time Frame: Baseline, Post Treatment (14-weeks), Follow-up (26-weeks)
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Change in PTSD Symptoms will be assessed using the Clinician-Administered PTSD Scale DSM 5 (CAPS-5)
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Baseline, Post Treatment (14-weeks), Follow-up (26-weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Sleep Efficiency
Time Frame: Baseline, Post Treatment (14-weeks), Follow-up (26-weeks)
|
Change in sleep efficiency, calculated as time spent sleeping divided by time spent in bed.
This data is acquired from daily sleep logs filled out by patient.
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Baseline, Post Treatment (14-weeks), Follow-up (26-weeks)
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Change in Quality of Life
Time Frame: Baseline, Post Treatment (14-weeks), Follow-up (26-weeks)
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Change in Quality of life will be assessed using the World Health Organization Quality of Life-BREF (WHOQOL-BREF) questionnaire.
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Baseline, Post Treatment (14-weeks), Follow-up (26-weeks)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Client Satisfaction Questionnaire (CSQ)
Time Frame: up to 26 weeks
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CSQ assesses client satisfaction for therapy session
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up to 26 weeks
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Pain Disability Questionnaire (PDQ)
Time Frame: up to 26 weeks
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PDQ assesses functional impairment due to pain
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up to 26 weeks
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Nox T3 recorders - Obstructive Sleep Apnea (OSA)
Time Frame: Pre-Treatment
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The Nox T3 recorders are a portable sleep monitoring system that can accurately diagnose OSA.
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Pre-Treatment
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Medications Use Interview:
Time Frame: Pre-treatment
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Assesses medication use
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Pre-treatment
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Collaborators and Investigators
Investigators
- Principal Investigator: Peter Colvonen, PhD, VA San Diego Healthcare System, San Diego, CA
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D2120-W
- 1lK2Rx002120-01 (Other Grant/Funding Number: Federal Identifier)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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