Integrated CBT-I and PE on Sleep and PTSD Outcomes (Impact Study)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02774642|
Recruitment Status : Recruiting
First Posted : May 17, 2016
Last Update Posted : October 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Posttraumatic Stress Disorders Chronic Insomnia||Behavioral: CBTI-PE Behavioral: Hygiene-PE||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The Impact of Integrated CBT-I and PE on Sleep and PTSD Outcomes|
|Actual Study Start Date :||October 1, 2016|
|Estimated Primary Completion Date :||March 31, 2021|
|Estimated Study Completion Date :||September 30, 2021|
Integrates the core components of CBT-I and PE in 14 90-minute weekly sessions.
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.
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.
- Change in PTSD Symptoms [ Time Frame: Baseline, Post Treatment (14-weeks), Follow-up (26-weeks) ]Change in PTSD Symptoms will be assessed using the Clinician-Administered PTSD Scale DSM 5 (CAPS-5)
- 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.
- Change in Quality of Life [ Time Frame: Baseline, Post Treatment (14-weeks), Follow-up (26-weeks) ]Change in Quality of life will be assessed using the World Health Organization Quality of Life-BREF (WHOQOL-BREF) questionnaire.
- The Client Satisfaction Questionnaire (CSQ) [ Time Frame: up to 26 weeks ]CSQ assesses client satisfaction for therapy session
- Pain Disability Questionnaire (PDQ) [ Time Frame: up to 26 weeks ]PDQ assesses functional impairment due to pain
- Nox T3 recorders - Obstructive Sleep Apnea (OSA) [ Time Frame: Pre-Treatment ]The Nox T3 recorders are a portable sleep monitoring system that can accurately diagnose OSA.
- Medications Use Interview: [ Time Frame: Pre-treatment ]Assesses medication use
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02774642
|Contact: Peter Colvonen, PhDfirstname.lastname@example.org|
|United States, California|
|VA San Diego Healthcare System, San Diego, CA||Recruiting|
|San Diego, California, United States, 92161|
|Contact: Gerhard H Schulteis, PhD 858-642-3657 email@example.com|
|Principal Investigator: Peter Colvonen, PhD|
|Principal Investigator:||Peter Colvonen, PhD||VA San Diego Healthcare System, San Diego, CA|