Feasibility and efficacy estimate of an emotion-focused version of Cognitive Behavior Therapy (CBT-E) for delusions in comparison to wait list in a single-blinded randomized-controlled pilot trial

Background: Cognitive Behavior Therapy for psychosis (CBTp) effectively reduces positive symptoms, but the effects for delusions are small. Using approaches that focus on improving putative causal factors of delusions (emotion regulation (ER) and negative self-schemata) may be a way to improve CBTp for delusions. Objectives: To pilot an emotion-focused CBTp intervention comprised of elements of different third wave approaches targeting ER and negative self-schemata (CBT-E) to investigate its feasibility and its potential efficacy. Methods : A single-blind two-centered randomized wait-list controlled trial was performed. Patients with delusions in the context of a psychotic disorder ( n =64) were randomized to CBT-E (treatment group (TG): n =35) or wait list (WL: n =29). TG received individual CBT-E in weekly sessions over six months, WL received CBT-E after a 6-months waiting time. Assessments were performed at baseline, after six months, and after 12 months. Results: Rates of patients who consented and retained in CBT-E suggest acceptable feasibility and high acceptance of CBT-E. Multiple regression analysis in the intent-to-treat sample revealed no significant advantage in favor of TG in the primary outcome delusions (PSYRATS delusions), no effect on ER or negative self-schemata and a significant advantage in only one of the eight additional secondary outcome variables, namely general psychopathology. Discussion: Although the intervention was feasible and acceptable, its effects on delusions did not hold up with the effects found for ‘targeted’ approaches in previous research and it needs to be improved to produce a stronger effect on the targets ER and self-schemata, before proceeding to a large-scale RCT. This study’s primary aim was to test the feasibility and acceptance of an intensified emotion-oriented version of CBTp (CBT-E) for patients with psychosis and delusions that targets emotion regulation and negative self-schemata. A second aim was to probe for the efficacy of CBT-E to estimate an adequate sample size for a fully powered and more rigorous RCT. Specifically, we tested whether CBT-E would be more effective than routine care (wait list (WL)) in improving delusions (primary outcome) and in reducing positive symptoms, negative symptoms, general psychopathology, depression, and improving social functioning (main secondary outcomes). We also explored CBT-E’s effect on improving putative causal factors of change in delusions (emotion regulation including worrying, self-schemata) which we assumed to be putative mediators of change in delusions. In addition, we assessed the sustainability of primary and secondary outcome factors and putative mediators of delusions at a 12-months-follow-up. A final aim was to test whether patients would welcome support from a co-therapist and whether adding support from a co-therapist can improve the interventions’ efficacy. The study design was a single-blind randomized wait-list controlled trial comparing individual CBT-E (TG) plus routine care (monthly psychiatric visits) with a wait list condition receiving routine care only (WL). The WL-group received CBT-E after six months of waiting time. Assessments were performed at the start of therapy, post six months waiting time (WL-group), post (approximately) six months of therapy, and after a 12-months-follow-up (FU) post CBT-E. All patients receiving CBT-E were offered support by a co-therapist, but acceptance of this support was not mandatory for trial participation. (3) interventions to reduce negative self-schemata including psychoeducation on self-acceptance and the role of positive and negative self-schemata, implementing a diary to report self-schemata and related cognitions, challenging negative self-schemata and related cognitions using Socratic reasoning, chair work, imagination strategies and helpful self-instructions. In the final sessions, interventions and helpful coping strategies were recapitulated. they and case supervision after every second by one of the study PIs (SM/TL). Co-therapists were 17 students of psychology who received 20 sessions of similar training as the therapists and individual weekly supervision by their therapists, and supervision every second week by one of the study PIs (SM). Also, they met with their fellow co-therapists in weekly collegial intervision sessions.