Clinical Trial Radar

Feasibility Indicator: Number of Participants Screened

Feasibility assessment will include number of participants screened defined as number of individuals who complete our initial eligibility screener.

Baseline

Feasibility Indicator: Enrollment

Feasibility assessment will include enrollment defined as number of participants signing the informed consent form.

Baseline

Feasibility Indicator: Number of Sessions Attended

Feasibility assessment will include the number of sessions attended on average (out of 12).

Post-Treatment Assessment at approximately 6 weeks

Feasibility Indicator: Attrition Percentage

A feasibility measure of attrition will be assessed by examining the percent of individuals who did not complete all 12 intervention sessions.

Post-Treatment Assessment at approximately 6 weeks

Feasibility Indicator: Number of Assessments Attended

A feasibility indicator of number of assessments (baseline and post-treatment) attended will be measured.

Baseline and Post-Treatment Assessment at approximately 6 weeks

Feasibility Indicator: Percentage of Self-Reports Completed

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.

Baseline, Post-Intervention at approximately 6 weeks, Every Other Treatment Session (Every 2 weeks up to 12 weeks)

Intervention Satisfaction

Intervention satisfaction will be rated with a Likert scale ranging from 1-10 with greater scores indicating higher satisfaction.

Post-Treatment Assessment at approximately 6 weeks

Intervention Acceptability

Intervention acceptability will be measured on a Likert scale ranging from 1-10 with greater scores indicating higher acceptability.

Post-Treatment Assessment at approximately 6 weeks

Qualitative Intervention Feedback

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.

Post-Treatment Assessment at approximately 6 weeks

Change in Score on the Clinician Administered PTSD Score (CAPS-5)

Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Score. Total Scores range from 0-80. Higher scores indicate greater symptom severity.

Baseline to approximately 6 weeks

Change in Score on the PTSD Checklist for DSM-5 (PCL-5)

The well-validated PCL-5 will assess self-reported PTSD symptom severity. Scores range from 0-80. Higher scores indicate greater symptom severity.

Baseline to approximately 6 weeks

Change in Score on the Pain Severity Subscale of the Brief Pain Inventory (BPI)

Pain severity is a 4-item subscale with ranges from 0-10. Greater scores indicate higher pain severity.

Baseline to approximately 6 weeks

Change in Score on the Pain Interference Subscale of the Brief Pain Inventory (BPI)

Pain interference is a 7-item subscale with ranges from 0-10. Greater scores indicate greater pain interference.

Baseline to approximately 6 weeks

Change in Score on the Pain Catastrophizing Scale (PCS)

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.

Baseline to approximately 6 weeks

Change in Score on the Chronic Pain Acceptance Questionnaire (CPAQ)

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.

Baseline to approximately 6 weeks

Change in Score on the Posttraumatic Cognitions Inventory (PTCI)

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.

Baseline to approximately 6 weeks

Change in Score on the Fear-Avoidance Components Scale (FACS)

This 20-item measure results in total scores ranging from 0-100, with greater scores indicating more severe fear-avoidance beliefs.

Baseline to approximately 6 weeks

Change in Score on the Anxiety Sensitivity Index (ASI-3)

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.

Baseline to approximately 6 weeks

Change in Score on the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST)

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.

Baseline to approximately 6 weeks

Change in Score on the Expectancies for Alcohol Analgesia (EAA) Measure

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.

Baseline to approximately 6 weeks

Change in Score on the Difficulties in Emotion Regulation Scale (DERS-18)

This 18-item measure results in a total score ranging from 18-90 with higher scores reflecting greater difficulties with emotion regulation.

Baseline to approximately 6 weeks

Change in Score on the Patient Health Questionnaire (PHQ-9)

The PHQ-9 scores range from 0-27. Higher scores indicate greater symptom severity.

Baseline to approximately 6 weeks

Change in Score on the Insomnia Severity Index (ISI)

7 item self-report measure. Total scores range from 0-28, with higher scores indicating higher insomnia severity.

Baseline to approximately 6 weeks

Change in Score on the Multidimensional Assessment of Interoceptive Awareness (MAIA-2)

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.

Baseline to approximately 6 weeks

Change in Score on the Quality of Life Inventory (QOLI)

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.

Baseline to approximately 6 weeks