Feasibility and initials signals of efficacy of a digital mental health promotion training for young people with climate change-related distress: Protocol for a feasibility randomized controlled trial

TY - UNPB

T1 - Feasibility and initials signals of efficacy of a digital mental health promotion training for young people with climate change-related distress

T2 - Protocol for a feasibility randomized controlled trial

AU - Fleck, Leonie

AU - Wasmus, Henrik

AU - Schirmbeck, Frederike

AU - de Freitas, Claudia

AU - Teixeira, Raquel Mara

AU - Sanna, Liuska

AU - de Graaff, Anne M.

AU - De Allegri, Manuela

AU - Nguyen, Hoa Thi

AU - Boehnke, Jan R.

AU - Kazlauskas, Evaldas

AU - Tol, Wietse

AU - Reininghaus, Ulrich

N1 - © The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.

PY - 2025/5/19

Y1 - 2025/5/19

N2 - Background: Efforts in mental health research have long focused on the care and long-term outcomes of mental disorders. More recently, a shift in focus has occurred towards mental health promotion and prevention. One priority target population for promotion and prevention are youth with climate change-related distress. In light of the real-world threat of climate change, adaptive emotion regulation and the ability to engage in meaningful action are two important strategies to promote mental health. Ecological Momentary Interventions (EMIs) allow for the delivery of accessible interventions for young people with climate change-related distress, but evidence on their feasibility or beneficial effects is currently lacking. Objective: To examine the feasibility and initial signals of efficacy of the CliMACT training, a novel hybrid EMI for mental health promotion in youth with climate change-related distress. Methods: A 2-arm, parallel-group, assessor- and analyst-blinded feasibility randomized controlled trial (RCT) will be conducted in n = 50 young people aged 14-25 years with climate change-related distress, who will be allocated on a 1:1 ratio to the experimental condition (CliMACT training + care as usual) or the control condition (care as usual only). CliMACT involves three sessions with a mental health professional and 6-week access to a smartphone-based EMI to support real-world transfer of training content based on Compassion Focused Interventions as well as Acceptance and Commitment Therapy. The EMI delivery schemes involve enhancing (introducing new EMI components), consolidating (training of EMI components), and adaptive (triggered in moments of higher negative affect) components. Care as usual involves access to all standard health care and social services. Feasibility criteria of the trial methodology include recruitment, randomization and retention. Feasibility outcomes of delivering the CliMACT training include participant satisfaction, participant adherence, mental health professionals’ fidelity to the training protocol. Initial signals of efficacy on mental health candidate outcomes and mechanisms will be explored. As feasibility criteria for a priori planned subgroup analyses, credibility criteria will be established and distributions of indicators for health inequities explored. Feasibility criteria for measuring costs of care and service use and health-related quality of life for an economic evaluation in a future definitive RCT will include exploring response distributions across groups. Candidate outcomes and mechanisms will be assessed at baseline, post-training, and 4-week follow-up, using self-report and six days of ecological momentary assessment (EMA). Results: The first enrolment took place in December 2024. We expect data collection to be completed by August 2025. Conclusions: specifically at young people with climate change-related distress. If feasibility can be established, the trial will inform a future fully powered efficacy-effectiveness RCT, accompanied by an economic evaluation. Clinical Trial: ISRCTN33613914, https://doi.org/10.1186/ISRCTN33613914

AB - Background: Efforts in mental health research have long focused on the care and long-term outcomes of mental disorders. More recently, a shift in focus has occurred towards mental health promotion and prevention. One priority target population for promotion and prevention are youth with climate change-related distress. In light of the real-world threat of climate change, adaptive emotion regulation and the ability to engage in meaningful action are two important strategies to promote mental health. Ecological Momentary Interventions (EMIs) allow for the delivery of accessible interventions for young people with climate change-related distress, but evidence on their feasibility or beneficial effects is currently lacking. Objective: To examine the feasibility and initial signals of efficacy of the CliMACT training, a novel hybrid EMI for mental health promotion in youth with climate change-related distress. Methods: A 2-arm, parallel-group, assessor- and analyst-blinded feasibility randomized controlled trial (RCT) will be conducted in n = 50 young people aged 14-25 years with climate change-related distress, who will be allocated on a 1:1 ratio to the experimental condition (CliMACT training + care as usual) or the control condition (care as usual only). CliMACT involves three sessions with a mental health professional and 6-week access to a smartphone-based EMI to support real-world transfer of training content based on Compassion Focused Interventions as well as Acceptance and Commitment Therapy. The EMI delivery schemes involve enhancing (introducing new EMI components), consolidating (training of EMI components), and adaptive (triggered in moments of higher negative affect) components. Care as usual involves access to all standard health care and social services. Feasibility criteria of the trial methodology include recruitment, randomization and retention. Feasibility outcomes of delivering the CliMACT training include participant satisfaction, participant adherence, mental health professionals’ fidelity to the training protocol. Initial signals of efficacy on mental health candidate outcomes and mechanisms will be explored. As feasibility criteria for a priori planned subgroup analyses, credibility criteria will be established and distributions of indicators for health inequities explored. Feasibility criteria for measuring costs of care and service use and health-related quality of life for an economic evaluation in a future definitive RCT will include exploring response distributions across groups. Candidate outcomes and mechanisms will be assessed at baseline, post-training, and 4-week follow-up, using self-report and six days of ecological momentary assessment (EMA). Results: The first enrolment took place in December 2024. We expect data collection to be completed by August 2025. Conclusions: specifically at young people with climate change-related distress. If feasibility can be established, the trial will inform a future fully powered efficacy-effectiveness RCT, accompanied by an economic evaluation. Clinical Trial: ISRCTN33613914, https://doi.org/10.1186/ISRCTN33613914

KW - climate change

KW - climate change distress

KW - ecological momentary intervention

KW - ecological momentary assessment

KW - mHealth

KW - youth

KW - feasibility

KW - randomized controlled trial

U2 - 10.2196/preprints.77764

DO - 10.2196/preprints.77764

M3 - Preprint

BT - Feasibility and initials signals of efficacy of a digital mental health promotion training for young people with climate change-related distress

PB - JMIR Publications

ER -