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Pilot study of feasibility, acceptability, and changes in clinical outcomes following a brief trauma-focused
Jolin B Yamin1,2, Jenna M Wilson3,2, John A Sturgeon4
1Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Chestnut Hill, Massachusetts, USA jyamin@bwh.harvard.edu.
Background:
Trauma exposure is prevalent among individuals with chronic pain and is associated with poorer pain-related outcomes. Brief, scalable interventions that target overlapping trauma-pain processes are needed. This single-arm pilot study evaluated feasibility, acceptability, and changes in clinical outcomes following Stress, Trauma, and Emotional Processing for Pain (STEPP), a brief modified version of emotional awareness and expression therapy.
Methods:
Adults (N=42) with mixed-etiology chronic pain and trauma exposure were enrolled. STEPP was delivered remotely over three weekly 1-hour individual sessions. Participants completed questionnaires at baseline, post-treatment, and 1-month, and 3-month follow-up. Feasibility benchmarks (≥70%) were prespecified for recruitment, treatment, and follow-up completion. Acceptability was assessed using the Treatment Helpfulness Questionnaire (THQ; -5 to 5) and Credibility and Expectancy Questionnaire (content credibility and expected benefit; 3-27). Linear mixed models and Hedges' g effect sizes examined changes in pain intensity (0-10) and interference with functioning (0-100), post-traumatic stress disorder symptoms (PTSD; 0-80), pain catastrophizing (concerns about pain; 0-52), and kinesiophobia (fear of movement; 17-68).
Results:
All feasibility benchmarks were met. 93% of eligible participants enrolled, 90% of enrolled participants initiated treatment, and 97% initiators completed treatment. Among completers, follow-up completion was 100% at post-treatment and 97% at 1 and 3 months. THQ ratings were high and met benchmarks (post M=4.0±1.2; 1-month M=3.9±1.2; 3-month M=3.8±1.3). Credibility ratings met benchmarks, whereas expectancy ratings did not. Significant improvements were observed from baseline to post-treatment: pain intensity (mean change=-0.64, SE=0.23, 95% CI -1.11 to -0.18), pain interference (-3.34, SE=0.84, 95% CI -5.00 to -1.68), PTSD (-5.60, SE=1.53, 95% CI -8.64 to -2.57), pain catastrophizing (-6.69, SE=1.34, 95% CI -9.34 to -4.03), and kinesiophobia (-5.78, SE=1.21, 95% CI -8.19 to -3.37); changes were maintained through 3 months. Effect sizes were small for pain intensity and moderate-to-large for all other outcomes.
Conclusions:
STEPP demonstrated feasibility and acceptability, with promising improvements in pain-related and trauma-related outcomes. Randomized controlled trials are needed to establish efficacy.