Study protocol and rationale for a pilot randomized clinical trial comparing processing of positive memories technique with supportive counseling for PTSD

Abstract

BackgroundResearch indicates that positive memories have a role in posttraumatic stress disorder's (PTSD) symptomatology and treatment. Following treatment development guidelines, a novel PTSD intervention – Processing of Positive Memories Technique (PPMT) – was developed and subsequently examined for its effects and feasibility in pilot studies. Extending this research, the proposed pilot randomized clinical trial with PPMT and Supportive Counseling (SC) arms will examine PPMT's effects on PTSD severity and biomarkers of stress systems' dysregulation (awakening salivary alpha amylase [sAA] and cortisol concentrations); examine mechanistic targets (affect) underlying PPMT's effects; and refine PPMT. We hypothesize that the PPMT arm will report greater decreases in PTSD severity and greater decreases in awakening sAA/cortisol ratio compared to the SC arm; and that improved affect (more positive affect and less negative affect) will mediate associations between intervention arm and changes in PTSD severity. MethodsWe will recruit 70 individuals aged 18–65 years with PTSD. They will be randomized to 5 weekly therapy sessions of PPMT or SC, and will be assessed at baseline, weekly during treatment, 1-week post-treatment, and 3-months post-treatment. Primary outcomes are past-week PTSD severity, past-week positive and negative affect levels, and feedback data on PPMT's feasibility, format, and content. The secondary outcome is the awakening sAA/cortisol ratio. Statistical analyses include mixed-effect models and within-subjects cross-lag longitudinal mediation analyses. ConclusionStudy results will advance knowledge of trauma interventions by examining effects and feasibility of a novel PTSD intervention, and by elucidating potential mechanisms underlying PPMT's effects.Clinical Trials #: NCT05523453