T-RAC: Study protocol of a randomised clinical trial for assessing the acceptability and preliminary efficacy of adding an exergame-augmented dynamic imagery intervention to the behavioural activation treatment of depression

PLoS One. 2023 Jul 31;18(7):e0288910. doi: 10.1371/journal.pone.0288910. eCollection 2023.

Abstract

Background: Improving the existent effective treatments of depression is a promising way to optimise the effects of psychological treatments. Here we examine the effects of adding a rehabilitation type of imagery based on exergames and dynamic simulations to a short behavioural activation treatment of depression. We investigate the acceptability and the efficacy of an exergame-augmented dynamic imagery intervention added to behavioural activation treatment and associated mechanisms of change.

Methods and analyses: In a two-arm pilot randomised controlled trial, the acceptability and preliminary efficacy of an exergame-augmented dynamic imagery intervention added to behavioural activation treatment for depressed individuals will be assessed. Participants (age 18-65) meeting criteria for depression are recruited by media and local announcements. 110 participants will be randomly allocated to behavioural activation plus imagery group or to standard behavioural activation group. The primary outcome is depressive symptom severity (Beck Depression Inventory II) and secondary outcomes are anhedonia, apathy and behavioural activation and avoidance. The outcomes are assessed at baseline, mid treatment, posttreatment and 3-month follow-up. Moderation and mediation analyses will be explored. An intention-to-treat approach with additional per-protocol analysis will be used for data analysis.

Publication types

  • Clinical Trial Protocol
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Behavior Therapy
  • Cognitive Behavioral Therapy* / methods
  • Depression / therapy
  • Exergaming
  • Humans
  • Imagery, Psychotherapy
  • Middle Aged
  • Randomized Controlled Trials as Topic
  • Treatment Outcome
  • Young Adult

Grants and funding

A.T PN-III-P1-1.1-TE-2021-1090, within PNCDI III. Ministry of Research, Innovation and Digitization, CNCS - UEFISCDI,https://uefiscdi-direct.ro/ The funders did not and will not have a role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.