Telehealth-Based Psychoeducation for Caregivers: The Family Intervention in Recent-Onset Schizophrenia Treatment Study

Abstract

Background: Schizophrenia is a lifelong illness that requires long-term treatment and caregiving. Family psychoeducation (FP) has been shown to lessen caregiver burden, improve caregiver functioning, and improve outcomes in patients. However, the impact of FP delivered specifically to caregivers on patient outcomes has not been well explored, particularly for early schizophrenia. Furthermore, there is a lack of research examining the benefits of telehealth-based psychoeducation for caregivers on either patient or caregiver outcomes.

Objective: The Family Intervention in Recent-Onset Schizophrenia Treatment (FIRST) study is a randomized controlled trial of patients with schizophrenia spectrum disorders and their caregivers, which is designed to evaluate the effect of telehealth-based, caregiver-focused, study-provided psychoeducation versus usual care (UC) on patient treatment failure (TF). The impact of study-provided psychoeducation on caregiver burden is also investigated.

Methods: Eligible patients and their designated caregivers were randomly assigned to either the study-provided psychoeducation (≤16 sessions of telehealth-based psychoeducation over 6 months) or UC group, stratified by antipsychotic treatment (paliperidone palmitate or oral antipsychotic). The major TF events (ie, psychiatric hospitalization or intervention, arrest or incarceration, and suicide attempts) were assessed at 3, 6, and 12 months after baseline. A proportional means model using mean cumulative function was used to assess between-group differences in the mean cumulative number of TF events over 12 months. Caregiver burden was assessed using the Involvement Evaluation Questionnaire and 12-item Short Form Health Survey.

Results: A total of 148 pairs of participants were enrolled in the study, of whom 96 (64.9%) patients and 94 (63.5%) caregivers completed the 12-month follow-up. The mean number of sessions in the study-provided psychoeducation group was 7.7 (SD 5.9). No differences were observed between the study-provided psychoeducation and UC groups in patient outcomes (rates of TF: 70% vs 67%; P=.90) or measures of caregiver burden (assessment of caregiver distress and physical and mental health). However, post hoc analyses revealed lower relapse rates in patients who received paliperidone palmitate than in those who received oral antipsychotics at all time points. Although the FIRST study did not meet the primary end point, several key lessons were identified to inform future caregiver-focused, telehealth-based FP interventions. Lack of study-provided psychoeducation, focus on caregiver-only intervention, difficulties with enrollment, and caregiver-treatment team coordination may have affected the outcomes of the FIRST study.

Conclusions: Key insights from the FIRST study suggest the potential importance of supporting sufficient caregiver engagement; communication between clinicians, patients, and family members regarding treatment plans; and solidifying the relationship between clinicians providing psychoeducation to the caregiver and patient treatment team.

Trial registration: ClinicalTrials.gov NCT02600741; https://ichgcp.net/clinical-trials-registry/NCT02600741.

Keywords: caregiver burden; family psychoeducation; recent-onset schizophrenia; schizophrenia; telehealth.

Conflict of interest statement

Conflicts of Interest: EDA has received consulting fees from F Hoffmann-La Roche; served on advisory boards for Indivior, Janssen, Neurocrine Biosciences, Sunovion, and Otsuka or Lundbeck; received research support from Alkermes, Astellas, Avanir, Biogen, Boehringer Ingelheim, InnateVR, Janssen, National Network of Depression Centers, Neurocrine Biosciences, Novartis, Pear Therapeutics, Pine Rest Foundation, Otsuka, Takeda, and Vanguard Research Group; has owned stock in AstraZeneca, Johnson & Johnson, Pfizer, Inc, and Moderna; and served as an investigator in this study but was not paid to be an author of this manuscript. JG, BM, and HLS are employees of Janssen Scientific Affairs, LLC, and stockholders of Johnson & Johnson, Inc. EK is a former employee of Janssen Scientific Affairs, LLC, and a stockholder of Johnson & Johnson, Inc.

©Kim T Mueser, Eric D Achtyes, Jagadish Gogate, Branislav Mancevski, Edward Kim, H Lynn Starr. Originally published in JMIR Mental Health (https://mental.jmir.org), 15.04.2022.

Figures

Figure 1

FIRST study design. In the FIRST study, caregivers randomized to the study-provided psychoeducation received up to 16 study-provided psychoeducation and skills training sessions within a 6-month period. UC consisted of caregiver support that was customarily provided by the study site (if any). FIRST: Family Intervention in Recent-Onset Schizophrenia Treatment; UC: usual care.

Figure 2

Disposition of study pairs in the FIRST study. Study patient pairs comprised individuals with schizophrenia and their designated caregivers. Patients could have ≥1 reason for screen failure. FIRST: Family Intervention in Recent-Onset Schizophrenia Treatment; UC: usual care.

Figure 3

Cumulative mean functions of treatment failure because of any event in the study-provided psychoeducation and UC groups UC: usual care.

Figure 4

Treatment failure rates by antipsychotic treatment strata (post hoc analysis). Efficacy analysis set (n=130, all patients who entered the study and had at least one postbaseline efficacy assessment). UC: usual care.