A virtual-reality based intervention on thoughts of the future self to reduce negative affect, depression, and suicidal ideation: protocol for a feasibility and acceptability randomized controlled pilot trial (FutureU for Mental Health).

BACKGROUND: Thinking about the future in a clear and detailed way is critical to daily life, generating meaning, motivation, and well-being overall. In depression and suicidal ideation (SI), executive functioning deficits can make future-oriented thinking (FT) particularly effortful. Many interventions address the quality of future thinking in depression and SI but are limited by the thoughts that a person can generate on their own. Finding ways to intervene on FT that do not rely fully on the overburdened cognitive processes of a person experiencing depression or SI may improve the efficacy of these interventions. The present pilot RCT investigates the feasibility, acceptability, and proof of concept for a novel virtual-reality (VR)-based intervention on thoughts of the future self (FutureU for Mental Health; FU-MH) to improve a person's ability to think about the future and to reduce symptoms of depression and SI. METHODS: Using a 4-month, randomized, controlled, participant-blind, add-on superiority trial with three parallel groups, we will evaluate the potential of a two-part VR-based intervention on thoughts of the future and the future self to reduce negative affect and depressive symptoms. We aim to recruit 60 participants and randomize them to either a control group, treatment group A, or treatment group B, where treatment groups are exactly the same with the exception of the order of presentation for intervention parts. Feasibility will be measured in terms of enrollment and retention, as well as subjective measures of participant engagement and embodiment in VR. Acceptability will be measured through participant self-report. Proof of concept will be evaluated through the demonstration of the intended effect on targeted cognitive mechanisms, evidence of improvement in clinical outcomes, and evidence of efficacy among those with cognitive processing deficits. DISCUSSION: This study will provide valuable direction for further iterations of FutureU for Mental Health and a larger scale clinical trial. Implications of hypothesized outcomes include support for a novel intervention on thoughts of the future self in depression and SI, and VR as a novel medium of intervention and prevention in depression and SI. TRIAL REGISTRATION: This trial was preregistered with OSF Registries prior to the beginning of any data collection on October 9, 2022 (doi: https://osf.io/8c5n6 ).