The unified protocol (UP) had larger effect sizes for improving symptoms compared with presented centered therapy (PCT) or treatment as usual (TAU) in veterans exposed to trauma. These study findings were published in Depression and Anxiety.
Researchers conducted a pilot hybrid type 1 trial at the Veterans Affairs Boston Health Care System between 2017 and 2018. Veterans who were exposed to trauma (N=37) presenting for routine care were randomly assigned in a 1:1:1 ratio to receive UP (n=13), PCT (n=13), or TAU (n=11). The UP and PCT sessions lasted 50 minutes. The UP intervention contained components similar to cognitive behavioral therapy and comprised 8 modules whereas PCT was a manualized supportive therapy focused on current symptoms and functioning. The outcomes of this study were the change in symptom severity at 3 months.
The TAU, PCT, and UP cohorts included patients with mean ages of 51.04, 48.08, and 42.08 years; 100.0%, 84.6%, and 61.5% were men; 54.5%, 76.9%, and 84.6% were White; and the number of traumas was 14.27, 16.77, and 19.54, respectively.
The index trauma events included sexual assault (n=6), sudden violent death (n=5), life-threatening illness or injury (n=4), severe human suffering (n=4), combat or war-zone exposure (n=3), sudden accidental death (n=3), natural disaster (n=3), transportation accident (n=1), assault with a weapon (n=1), or other (n=5). At baseline, the most common diagnoses included major depressive disorder (n=11), posttraumatic stress disorder (n=9), and persistent depressive disorder (n=6).
Among the TAU group, 62.5% attended individual treatments with an average of 8.3 sessions, 27.3% received medication plus attended an average of 4.0 psychiatry sessions, 18.2% received both individual and group treatments, and 12.5% attended only group sessions (mean, 5.7 sessions). More PCT recipients dropped out of the study (38.5%) compared with no UP recipients (χ2, 3.96; P =.047).
Overall, effect sizes were largest for UP recipients with regard for the change between baseline and 3 months in Clinical Severity Rating scores (d, -3.23), the number of comorbid diagnoses (d, -0.66; P =.012), impairment in functioning (d, -0.55; P =.002), and 9-item Patient Health Questionnaire scores (d, -1.55; P <.001) compared with those in the PCT and TAU groups. Compared with only PCT, the effect sizes for UP were larger for the change in overall anxiety severity and impairment scale (OASIS) anxiety (d, -0.48; P =.006) and depression (d, -0.60; P ≤.001) scores.
This study was limited by the sample sizes and the group differences at baseline.
Study authors conclude, “This study demonstrates the promise of the UP for trauma-exposed individuals with multiple diagnoses. It also represents the first attempt to systematically examine the UP in a routine care setting. If replicated with a larger sample, the findings may suggest that the UP can serve as a transdiagnostic protocol to train clinicians in one evidence‐based cognitive behavioral therapy that can be applied across diverse patient populations.”
Gutner CA, Song J, Canale CA, et al. A pilot randomized effectiveness trial of the unified protocol in trauma‐exposed veterans. Depress Anxiety. Published online October 18, 2022. doi:10.1002/da.23288