Abstract / Summary
Motivational negative symptoms of schizophrenia are closely associated with diminished goal-directed behaviour. Goals in Focus (GiF) is a novel cognitive–behavioural intervention targeting a comprehensive set of mechanisms implicated in motivational negative symptoms and reduced goal-directed behaviour. This single-blind, randomised controlled pilot trial examined the feasibility, safety, and acceptability of GiF. Thirty Participants with schizophrenia-spectrum disorders and at least moderate motivational negative symptoms were randomised to receive either up to 24 GiF sessions over six months or a waitlist control condition. Blinded assessments were conducted at baseline and six months post-randomisation (T1). Feasibility was evaluated against prespecified criteria for recruitment, eligibility, consent, retention, data completeness, attrition, and treatment exposure. Safety and acceptability were assessed through adverse event monitoring and satisfaction ratings alongside qualitative feedback, respectively. Preliminary efficacy was examined using with the motivational negative symptoms subscale of the Brief Negative Symptom Scale as the primary outcome and ecological momentary assessment (EMA) of goal pursuit mechanisms. All feasibility criteria were met except for treatment exposure. GiF was safe and well accepted. The baseline-adjusted effect on motivational negative symptoms at T1 was small and imprecise (b = 0.94, 95% CI [−3.17, 5.05]), compatible with both improvement and deterioration. EMA outcomes showed more promising signals of improvement. Overall, GiF appears to be feasible safe and well accepted although refinements to treatment exposure are warranted before progressing to a definitive efficacy trial.