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Posttraumatic stress disorder (PTSD) occurs in approximately 7% of adults in the general population. PTSD greatly impacts quality of life and often co-occurs with other conditions such as chronic pain. Individuals with co-morbid PTSD and chronic pain demonstrate higher PTSD symptoms and pain (as well as greater anxiety, depression, disability, and opioid use) compared to those with only one of those conditions. Gold standard treatments exist for both PTSD (e.g., Prolonged Exposure; PE) and chronic pain (e.g., Cognitive Behavioral Therapy for Chronic Pain; CBT-CP) and are generally offered sequentially (i.e., one at a time for the condition that is most prominent). Treating these conditions separately may overlook their interconnected nature, which may reduce efficacy and increase dropout. Thus, there is a need for an intervention to target both simultaneously, which may be more effective and efficient than treating conditions sequentially. This is a single-arm pilot study to assess the feasibility and acceptability of an integrated treatment for adults with comorbid PTSD and chronic pain. The intervention consists of 12 90-minute virtual psychotherapy sessions scheduled twice per week. The treatment draws from modules in PE and CBT-CP including psychoeducation, exposure to feared/avoided situations and activities, processing of exposures, behavioral activation, breathing and relaxation techniques, sleep hygiene, symptom monitoring, and structured homework assignments. Baseline and post-treatment assessments will be conducted.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-06-15
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This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
The intervention consists of 12 90-minute virtual psychotherapy sessions scheduled twice per week. The treatment integrates modules from Prolonged Exposure and Cognitive Behavioral Therapy for Chronic Pain.
Eligibility
primary outcomes
Time frame: Baseline
Feasibility assessment will include number of participants screened defined as number of individuals who complete our initial eligibility screener.
Time frame: Baseline
Feasibility assessment will include enrollment defined as number of participants signing the informed consent form.
Time frame: Post-Treatment Assessment at approximately 6 weeks
Feasibility assessment will include the number of sessions attended on average (out of 12).
Time frame: Post-Treatment Assessment at approximately 6 weeks
A feasibility measure of attrition will be assessed by examining the percent of individuals who did not complete all 12 intervention sessions.
Time frame: Baseline and Post-Treatment Assessment at approximately 6 weeks
A feasibility indicator of number of assessments (baseline and post-treatment) attended will be measured.
Time frame: Baseline, Post-Intervention at approximately 6 weeks, Every Other Treatment Session (Every 2 weeks up to 12 weeks)
Self-reports are administered at each assessment (baseline and post-intervention) as well as every other treatment session (every 2 weeks up to 12 weeks). Therefore, there are 8 total self-report assessments and the percentage of those completed will be calculated.
Time frame: Post-Treatment Assessment at approximately 6 weeks
Intervention satisfaction will be rated with a Likert scale ranging from 1-10 with greater scores indicating higher satisfaction.
Time frame: Post-Treatment Assessment at approximately 6 weeks
Intervention acceptability will be measured on a Likert scale ranging from 1-10 with greater scores indicating higher acceptability.
Time frame: Post-Treatment Assessment at approximately 6 weeks
Open-ended questions that include assessing overall impressions of treatment, feedback on the frequency and length of sessions, challenges or barriers, likelihood of recommending this treatment to a friend, and comparison of this treatment to other treatments received in the past.
secondary outcomes
Time frame: Baseline to approximately 6 weeks
Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Score. Total Scores range from 0-80. Higher scores indicate greater symptom severity.
Time frame: Baseline to approximately 6 weeks
The well-validated PCL-5 will assess self-reported PTSD symptom severity. Scores range from 0-80. Higher scores indicate greater symptom severity.
Time frame: Baseline to approximately 6 weeks
Pain severity is a 4-item subscale with ranges from 0-10. Greater scores indicate higher pain severity.
Time frame: Baseline to approximately 6 weeks
Pain interference is a 7-item subscale with ranges from 0-10. Greater scores indicate greater pain interference.
Time frame: Baseline to approximately 6 weeks
The 13-item PCS measure has scores ranging from 0-52, with higher scores indicating greater pain catastrophizing. Three subscales (rumination, magnification, and helplessness) are summed to form the total score.
Time frame: Baseline to approximately 6 weeks
This 20-item measure results in a total score ranging from 0-120 with high scores reflecting greater acceptance of pain. Two subscales (activity engagement and pain willingness) are summed to create the total score.
Time frame: Baseline to approximately 6 weeks
The 33-item PTCI yields three subscores: negative cognitions about the self, negative cognitions about the world, and self-blame. Items are averaged so the range of scores for each subscale is 0-7 with higher scores representing more maladaptive cognitions. A total score is calculated by summing each of the 33 items yielding a score between 33-231, with higher scores indicating more maladaptive cognitions.
Time frame: Baseline to approximately 6 weeks
This 20-item measure results in total scores ranging from 0-100, with greater scores indicating more severe fear-avoidance beliefs.
Time frame: Baseline to approximately 6 weeks
This 18-item measure results in a total score ranging from 0-72 with higher scores reflecting greater anxiety sensitivity. Three subscales (physical concerns, cognitive concerns, and social concerns) are summed to create a total score.
Time frame: Baseline to approximately 6 weeks
The ASSIST is a questionnaire that screens for all levels of problem or risky substance use in adults including tobacco, alcohol, cannabis, cocaine, amphetamine-type stimulants, inhalants, sedatives, hallucinogens, opioids, and other drugs. A score for each substance ranges from 0-39 with higher scores indicating greater problems or risks related to substance use. A total score is not computed and instead, each substance will be analyzed individually.
Time frame: Baseline to approximately 6 weeks
The EAA is a 5-item scale. Items are summed to generate a total score ranging from 0-45 with higher scores indicating greater expectancy for alcohol analgesia.
Time frame: Baseline to approximately 6 weeks
This 18-item measure results in a total score ranging from 18-90 with higher scores reflecting greater difficulties with emotion regulation.
Time frame: Baseline to approximately 6 weeks
The PHQ-9 scores range from 0-27. Higher scores indicate greater symptom severity.
Time frame: Baseline to approximately 6 weeks
7 item self-report measure. Total scores range from 0-28, with higher scores indicating higher insomnia severity.
Time frame: Baseline to approximately 6 weeks
This is a 37-item measure that results in 8 subscales: noticing, not-distracting, not-worrying, attention regulation, emotional awareness, self-regulation, body listening, and trust. Each subscale ranges from 0-5, where higher scores reflect more awareness of bodily sensations. A total score is not computed, and instead, each subscale is analyzed individually.
Time frame: Baseline to approximately 6 weeks
The assessment yields an overall score and profile in 16 areas of life; health, self-esteem, goals and values, money, work, play, learning, creativity, helping, love, friends, children, relatives, home, neighborhood, and community. Subscales are computed by multiplying satisfaction (-3 to +3) by importance (0 to 2) and resulting scores are averaged to yield a total score ranging from -6 to +6, with higher scores indicate higher level of quality of life.
Time frame: Baseline to approximately 6 weeks
This is a 5-item questionnaire measuring the extent to which one experiences conflict or struggle with spirituality or religious faith. Each item is rated on a scale from 1 (Not at All) to 5 (A Great Deal), thus higher scores indicate more spiritual struggle.
Publications
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