1 - (SYM 12) Introduction, Rationale, and Description of Methods for a Randomized Clinical Trial of an Augmented Version of the Internet-based UP Targeting Adaptive Positive Affect Regulation

The Unified Protocol (UP) is a transdiagnostic cognitive behavioral intervention targeting temperamental characteristics, particularly neuroticism and resulting emotion dysregulation underlying emotional disorders (Barlow et al., 2014). There is now ample empirical support for the efficacy of the UP in treating negative emotion regulation in anxiety, depressive, and related disorders; however, the effect of the UP on positive affect and positive emotion regulation is less clear, particularly in the long-term (Sakiris & Berle, 2019). We conducted a randomized clinical trial comparing our recently developed internet-based UP (iUP) to an augmented version of this protocol that more directly and intentionally targets the healthy regulation of positive emotions (iUP+). This presentation introduces the clinical trial and provides an overview of the study design and methodology.

To date, 47 treatment-seeking adults with a principal diagnosis of anxiety, obsessive-compulsive, or depressive disorder (76.6% White, 76.6% female, M age= 35.83) have completed either the original iUP (n = 13) or the iUP+ (n = 34). Analyses will be updated to reflect an expected sample of N = 120 by June 2023. Participants were randomized using a computerized block randomization sequence with a 2:1 allocation to study condition, favoring iUP+. Both treatments were developed with SilverCloud Health, a leading digital mental healthcare provider. The programs are being delivered through SilverCloud’s digital platform and were designed to be completed at a self-directed pace with guidance from “supporters” via weekly asynchronous messaging.

Assessments included a clinical interview conducted by trained evaluators blind to treatment condition at pre- and post-treatment and periodic self-report questionnaires. Questionnaires were administered at pre-treatment baseline; weeks four, eight, and twelve (i.e., post-treatment); and three-month follow-up (i.e., week 24). Outcome variables of interest included self- and clinician-rated severity of disorder-specific symptoms; weekly measures of anxiety and depression; functional impairment, quality of life, and flourishing; possible moderators of treatment outcome including credibility, acceptability, and readiness for change; virtues mechanisms including hope, humility, and forgiveness; and temperamental variables and psychopathologic mechanisms related to emotion and emotion regulation theorized to maintain difficulties in emotional disorders such as savoring and emotional suppression.