Trials. 2025 Jul 3;26(1):236. doi: 10.1186/s13063-025-08920-9.
ABSTRACT
BACKGROUND: There is an urgent need for psychological interventions that can target depression in late adolescence and prevent it from having lifelong implications. Schools have been identified as a promising setting to enhance access to interventions and offer support earlier. We have co-developed a novel intervention, IMAGINE, that targets key cognitive mechanisms implicated in depression across the lifespan. Depression has been associated with distressing negative mental images, a deficit in positive future images and overgeneral autobiographical memories. Interventions targeting these factors have shown clinical promise in adults. Here, we combine techniques targeting these cognitive processes into a novel, brief psychological intervention for adolescent depression. This Phase IIb randomised controlled trial will evaluate IMAGINE compared to an active psychological intervention.
METHODS/DESIGN: One hundred sixty adolescents (aged 16-18) with high levels of depressive symptoms will be recruited from schools. Participants will be randomly allocated to IMAGINE or the active psychological control intervention, non-directive support (NDS). Assessment will take place at baseline, 8-, 16- and 24-week post randomisation. The primary objective is to establish whether IMAGINE reduces symptoms of depression, relative to NDS, at 8 weeks following randomisation. Secondary objectives include whether changes in depression are maintained at 16- and 24-week follow-up, the efficacy of IMAGINE on secondary clinical outcomes and key cognitive mechanisms and, finally, to assess outcomes around acceptability, safety and adherence.
DISCUSSION: If IMAGINE is shown to be safe and clinically effective, an effectiveness-implementation hybrid RCT will be indicated. If rolled out as an intervention, IMAGINE would significantly extend the range of effective therapies available for adolescent depression.
TRIAL REGISTRATION: ISRCTN, ISRCTN14015295. Registered 11 September 2023, https://doi.org/10.1186/ISRCTN14015295 .
PMID:40611193 | DOI:10.1186/s13063-025-08920-9
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