Psychological Options for Wellness and Recovery (POWeR) Trial for Veterans With Chronic Back/Neck Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Colorado, Denver
About this trial
The goal of this clinical trial is to learn which treatment works better for veterans with chronic neck or back pain. This study is comparing three treatments: Pain Reprocessing Therapy (PRT), Cognitive Behavioral Therapy (CBT), and usual care (whatever a person is already doing to cope with their pain).
The main questions the study aims to answer are:
1. Which treatment works better for lowering pain: PRT, CBT, or usual care? 2. How do the effects of PRT compare with CBT and usual care in terms of pain relief and other factors such as emotional functioning, quality of life, anxiety, and pain medication use?
Participants will:
1. Be randomly assigned to receive either PRT, CBT, or usual care. 2. Complete questionnaires about their pain and health. 3. If in the PRT or CBT group, have nine weekly therapy sessions over video calls with a therapist.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults (18 and older)
Be veterans
Have a history of chronic back or neck pain defined as pain at least half the days of the last 6 months.
Have moderate or greater pain, defined as pain intensity ≥4 in the past week
Disqualifiers
Moderate or severe cognitive impairment
Unstable or severe untreated mental health condition, including active suicidal ideation
Unstable or end-stage medical disease including active cancer
Back surgery planned within the next 6 months
Trial design
Design model
Parallel
Treatments tested in this trial
Pain reprocessing therapy (PRT)
BehavioralA promising new psychotherapy for chronic pain
Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)
BehavioralA psychotherapy for chronic pain that has 30+ years of research support.
Usual Care
Other interventionParticipants will be asked to continue to do whatever they are currently doing to manage their pain.
Treatment groups
360 Participants
are divided into 3 treatment groupsGroup A: Pain reprocessing therapy (PRT)Experimental treatment 1 intervention
Group B: Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)Active comparator 1 intervention
Group C: Usual CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pain intensity
Last-week average pain intensity is assessed via the Brief Pain Inventory Short Form (BPI-SF). The BPI-SF assesses pain severity and its impact on functioning. It consists of 9 total items including 4 pain intensity items and 5 pain interference items. The 4 pain intensity items measure pain in the last week on a numerical rating scale of 0 (no pain at all) to 10 (pain as bad as you can imagine).
Time frame
Post-treatment (at an average of 10 weeks) and 26, 39, and 52 weeks post-randomizationSecondary outcomes
1
Pain Interference
Last-week average pain interference is assessed via the Brief Pain Inventory Short Form (BPI-SF). The BPI-SF assesses pain severity and its impact on functioning. It consists of 9 total items including 4 pain intensity items and 5 pain interference items. The 5 pain interference items measure the impact of pain on General Activity, Mood, Walking Ability, Normal Work, Relations with other people, Sleep, and Enjoyment of Life. Each area is rated on a numerical rating scale from 0 (does not interfere) to 10 (completely interferes).
Time frame
Post-treatment (at an average of 10 weeks) and 26, 39, and 52 weeks post-randomization2
Satisfaction with Life
Satisfaction with Life is assessed via the self-reported 5-Item Satisfaction with Life Scale (SWLS). The SWLS measures an individual's global life satisfaction. Each item is rated on a 7-point Likert scale (1=Strongly Disagree and 7=Strongly Agree). The ratings are summed to determine an overall score.
Time frame
Post-treatment (at an average of 10 weeks) and 26, 39, and 52 weeks post-randomization3
Depression
Depression is assessed using the self-reported 4-item Patient-Reported Outcomes Measurement Information System Depression Short Form 4a (PROMIS-Depression-SF 4a). The individual items measure negative mood, loss of interest, helplessness, and hopelessness over the past 7 days. Each item is scored 1-5, and raw scores are then converted to a T-score using pre-determined cut-offs.
Time frame
Post-treatment (at an average of 10 weeks) and 26, 39, and 52 weeks post-randomization4
Anxiety
Anxiety is assessed using the self-reported 4-item Patient-Reported Outcomes Measurement Information System Anxiety Short Form 4a (PROMIS-Anxiety-SF 4a). The form's items measure an individual's fear, worry, tension, and difficulty concentrating over the past 7 days. Each item is scored 1-5, and raw scores are then converted to a T-score using pre-determined cut-offs.
Time frame
Post-treatment (at an average of 10 weeks) and 26, 39, and 52 weeks post-randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Colorado, Denver
Lead sponsor
VA Eastern Colorado Health Care System
Collaborator
United States Department of Defense
Collaborator
Source ClinicalTrials.gov