Integrated CBT-I and PE on Sleep and PTSD Outcomes (Impact Study)

Not Applicable

Completed

• Conditions: Posttraumatic Stress Disorders; Chronic Insomnia
• Interventions: Behavioral: CBTI-PE; Behavioral: Hygiene-PE

• Registration Number: NCT02774642
• Lead Sponsor: VA Office of Research and Development

Brief Summary

This study aims to examine whether integrating insomnia and PTSD treatment will enhance sleep, PTSD, and quality of life outcomes. This is a randomized control trial comparing integrated evidence based CBT-I into PE (CBTI-PE) versus to a non-active sleep component plus PE (hygiene-PE) to optimize PTSD, sleep, and quality of life outcomes in 90 Veterans. Such benefits would further the VA's commitment to improving the mental health, recovery, and community reintegration of Veterans detailed in the 2014-2020 VHA Strategic Plan. Findings from the proposed study offer a unique opportunity to determine the malleability of mechanisms (e.g., Total sleep time, Sleep efficiency) that can improve recovery outcomes among this vulnerable population and to inform future treatment development and research. Improved PTSD, insomnia, and quality of life outcomes can decrease risk of chronic impairment and ultimately help affected Veterans live richer, more productive lives.

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 Timeline

• Study First Submitted: 2016-05-10
• Study First Submitted QC: 2016-05-12
• Study First Posted: 2016-05-17
• Study Start: 2016-10-01
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30
• Results First Submitted: 2023-10-13
• Status Verified: 2024-09
• Results First Submitted QC: 2024-09-11
• Last Update Submitted: 2024-09-11
• Results First Posted: 2024-10-08
• Last Update Posted: 2024-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBTI-PE	CBTI-PE	Integrates the core components of CBT-I and PE in 14 90-minute weekly sessions.
Hygiene-PE	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.

Primary Outcome Measures

Name	Time	Method
Change in PTSD Symptoms	Baseline, Post Treatment (14-weeks), Follow-up (26-weeks)	PTSD Symptoms will be assessed using the Clinician-Administered PTSD Scale DSM 5 (CAPS-5). Range (0 - 80). Lower scores equate to lower PTSD severity. Change in PTSD will be assessed longitudinally using linear mixed effects models of the CAPS-5 at each timepoint to estimate slope (change) over time.
Change in Sleep Efficiency	Baseline, Post Treatment (14-weeks), Follow-up (26-weeks)	Change in sleep efficiency. Sleep efficiency is calculated from two variables acquired from daily sleep logs filled out by patient: a) time spend in bed and b) time spent asleep. Sleep efficiency = time spent asleep / time spent in bed. Range (0 -100%). Higher sleep efficiency is better. Change in Sleep Efficiency will be assessed longitudinally using linear mixed effects models of measure at each timepoint to estimate slope (change) over time.

Secondary Outcome Measures

Name	Time	Method
Change in Quality of Life	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. All subscores, higher scores equate to better quality of life. Physical Health Range (7-35); Psychological Range (6-30); Social Relationships (3-15); Environment (8-40).
Change in Insomnia Severity	Baseline, week 5, Post Treatment (14-weeks), Follow-up (26-weeks)	Insomnia Severity will be assessed using the Insomnia Severity Index (ISI). Range (0 - 28). Lower scores equate to lower insomnia severity. Change in ISI will be assessed longitudinally using linear mixed effects models of the ISI scores at each timepoint to estimate slope (change) over time.

Trial Locations

Locations (1)

VA San Diego Healthcare System, San Diego, CA; 🇺🇸 San Diego, California, United States