Effectiveness of implementing family involvement on patient outcomes in individuals with psychotic disorders: a pragmatic cluster randomised controlled trial #MMPMID41345598
Norheim I; Pedersen R; Selle ML; Rossberg JI; Hestmark L; Heiervang KS; Ruud T; Asholt VM; Hansson KM; Moller P; Fosse R; Kjus SHH; Romoren M
BMC Psychiatry 2025[Dec]; 25 (1): 1142 PMID41345598show ga
BACKGROUND: The purpose of this sub-study, as part of the Implementation of guidelines on Family Involvement for persons with Psychotic disorders (IFIP) trial, was to examine the effectiveness of family interventions (FIs) implemented through an implementation support program (ISP) on patients' outcomes. METHODS: The IFIP trial is a cluster randomised controlled trial where 15 Community Mental Health Centre units were randomly allocated either to the ISP, which included FIs as clinical interventions, implementation strategies, and implementation interventions, or to treatment as usual (TAU). In the control arm, patients could have access to FIs. Patients with psychotic disorders in both arms were asked to complete questionnaires at inclusion, 6- and 12 months. The primary outcome was patients' difficulties in interpersonal relationships measured with the Relationships subscale of Behaviour and Symptom Identification scale. The secondary outcomes were patients' mental health and functioning, perceived expressed emotions, recovery, and quality of life. Linear mixed-effects models were used to analyse differences in change over time between the two arms. RESULTS: We included 231 patients (135 from the intervention units; 96 from the control units). Except for the first 24% of the 6 months questionnaires, the 6- and 12-month data were collected during the COVID-19 pandemic. There were no significant differences in the primary outcome, difficulties in interpersonal relationships at 12 months, between the intervention and control arms (Cohen's d = -0.19, p = 0.2). The secondary outcomes showed less perceived criticism from the relatives (Perceived Criticism sub-score; d = - 0.4, p = 0.01) and reduced difficulties in overall functioning (Health of the Nation Outcome Scale; d = - 0.29, p = 0.01) in the intervention arm compared to the control arm at 12 months. CONCLUSION: The FIs, implemented through the ISP, did not achieve significant decreases in patients' difficulties with interpersonal relationships. However, this sub-study indicates that FIs in routine mental health practices can nurture a more positive family environment and enhance the patient's process toward improved functioning. The complexity of the study design, and the restrictions due to COVID-19, may have diminished the implementation and effectiveness of the measured FIs for the patients. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT03869177. Registered 2019-02-28.
BMC+Psychiatry 2025 ; 25 (1): 1142
