“Goals in Focus” – A targeted CBT approach for motivational negative symptoms of psychosis: Study protocol for a randomized-controlled feasibility trial

Abstract Background: The reduction of goal-directed behavior is the core issue in motivational negative symptoms of psychosis as it accounts for the long-term decline in psychological wellbeing and psychosocial functioning. However, the available treatment options are largely unspecific and show only small effects on motivational negative symptoms. Interventions that directly target the relevant psychological mechanisms are likely to be more effective. With “Goals in Focus”, we translated findings from basic clinical research on mechanisms underlying motivational negative symptoms into a tailored and comprehensive novel psychological treatment program. With this study, we will test the feasibility of the therapy protocol and the trial procedures. We also aim to examine first estimates of the effect size that can be expected from Goals in Focus to inform the sample size calculation of a subsequent fully powered trial.Methods: We will conduct a single-blind randomized-controlled trial at the outpatient clinic of Universität Hamburg, Germany. Thirty participants diagnosed with a schizophrenia spectrum disorder and at least moderate motivational negative symptoms will be randomly assigned to either 24 sessions of “Goals in Focus” over the course of six months or to a 6-months waitlist control group. Assessments will be conducted at baseline (t0) and 6 months after baseline completion (t1). Feasibility and acceptability of the therapy protocol will be rated by practitioners and participants. Trial feasibility outcomes include patient recruitment, retention and attendance rates. The primary outcome for effect size estimation is defined as group differences in motivational negative symptoms at t1 corrected for baseline values. Secondary outcomes include psychosocial functioning, psychological well-being, depressive symptoms, expressive negative symptoms, negative symptom factor scores, and goal pursuit in everyday life.Discussion: The feasibility and acceptability data will be used to improve on the trial design and the provision of the “Goals in Focus” intervention where necessary. The treatment effect on the primary outcome will provide the basis for the sample size calculation for a fully powered RCT.Trial registration: 1) ClinicalTrials.gov Identifier: NCT05252039; https://clinicaltrials.gov/ct2/show/NCT05252039?term=goals&cond=Negative+Symptoms+with+Primary+Psychotic+Disorder&draw=2&rank=1; registered on 23 February 20222) Deutsches Register Klinischer Studien: Identifier: DRKS00018083https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00018083; registered on 28 August 2019