Trial Outcomes & Findings for Enhancing Mental Health Outcomes for Patients With Psychosis in Malawi Through Community-based Rehabilitation (NCT NCT06080477)

Study recruitment began in December 2023. Recruitment occurred in Queen Elizabeth Central Hospital (QECH) in Blantyre, Malawi.

Sixty-seven participants were screened for eligibility. Among those, seven were ineligible, and sixty provided informed consent. All consenting participants were randomized. Each person living with psychosis could participate with up to two caregivers. Caregivers provided consent and participated in study activities, but no outcome or adverse event data were collected. Results data presented reflect the randomized persons living with psychosis for whom outcome data were collected and analyzed.

Data are reported separately for Participants With Psychosis and Caregivers.

This measure is the ability to successfully enroll people with lived experience (PWLE) in the pilot intervention. Feasibility will be evaluated by measuring the number of participants approached in order to accrue the final sample.

Feasibility will be evaluated by measuring the proportion of participants retained in the study (participants enrolled at baseline who are still enrolled in the trial through 12 months).

A subset of intervention participants were asked if they were willing to participate in a qualitative interview. The 12 who agreed to participant were asked a series of qualitative questions including whether or not the intervention was helpful or unhelpful as a measure of satisfaction to inform intervention acceptability. The number indicating "helpful" as their response are reported.

The total number of participants who completed all three intervention phases, out of the number of all intervention participants. This outcome does not apply to Enhanced Usual Care and no data were collected.

Level of functioning will be evaluated using the World Health Organization Disability Assessment Schedule (WHODAS 2.0 12-item version). The WHODAS 2.0 measures general disability related to multiple domains (i.e., understanding and communicating, getting around, self care, getting along with people, life activities, work/school, participation in society). Total scores on each item range from 1 (no disability) to 5 (extreme/cannot do), with higher scores indicating more impairment. Total scores on the scale range from 12 to 60, with higher scores indicating more impairment.

Quality of life will be evaluated using the Short Form-8 (SF-8). The SF-8 is a shorter, 8-item questionnaire that covers the same eight domains as the full SF-36. The 8 items are scored using normed scoring that ranges from 0 to 100, with higher scores indicative of better quality of life.

Change in psychosis symptoms from baseline were evaluated using the Positive and Negative Symptoms Scale total scores (PANSS). Total scores range from 30 to 210 and include the total sum of all three sub-scales, with higher scores indicating worse outcomes. Scores reported are the change in symptoms relative to baseline.

Psychosis symptom response will be defined as the number of participants with a ≥20% reduction in symptoms from baseline as measured using the Positive and Negative Symptoms Scale (PANSS) total score. Total scores range from 30 to 210 and include a sum of all three sub-scales, with higher scores indicating worse outcomes.

Psychosis symptom remission was evaluated using the Positive and Negative Symptoms Scale (PANSS). Each PANSS item was scored on a scale from 1 to 7 with 1 = "absent" and and 7 = "extreme" with higher values indicating worse symptoms. Remission was defined as the number of participants who responded as having absent or minimal symptoms on items G5, G9, N1, N4, N6, and P1-3 in the PANSS.

Clinical improvement will be evaluated using the Clinical Global Impression-Improvement score (CGI-I). Clinical improvement will be measured as the number of participants with a score of 1 ("very much improved") or 2 ("much improved"). The CGI-I is a 1-7 scale, designed to evaluate improvement through a comparison with the initial assessment of the patient at baseline. Possible ratings range from "very much improved" (score of 1) to "very much worse" (score of 7).

Internalized stigma will be evaluated using the Internalized Stigma of Mental Illness Inventory (ISMI). A total score is calculated by taking a sum of the responses on the items (range=10 to 40). Higher total scores indicate greater internalized stigma.