Psychosis
Conditions
Brief summary
The overall aim of the proposed study is to determine the feasibility, acceptability, fidelity, and preliminary effectiveness of the adapted nurse-led, community-based rehabilitation treatment model for community-dwelling individuals living with psychosis in Blantyre, Malawi using a pilot randomized controlled trial.
Detailed description
Psychosis exacts a heavy morbidity and mortality toll worldwide, but especially in low- and middle-income countries (LMICs). Psychotic disorders are one of the most common presenting complaints for individuals admitted to specialty mental health services in many LMICs. Psychotic disorders typically have onset in early adulthood and a chronic course, meaning patients suffer from many years of poor functionality, disability, and lost productivity. Indeed, psychotic disorders remain among the 15 leading causes of disability globally. The chronicity and severity of psychotic disorders exert a heavy burden on family as relatives frequently have to assume caregiver roles in LMIC where access to formal mental health care is limited. Despite the significant toll of psychosis in LMICs, treatment options are extremely limited and focus heavily on acute, time-limited inpatient stabilization. This focus fails to consider the demonstrated need for long-term post-acute outpatient treatment and community-based rehabilitation to improve outcomes and prevent relapse. Contextual community factors such as reliable continued access to mental health care, stigma and its negative impact on medication adherence, inadequate support, and family conflict are key risk factors for subsequent relapse upon discharge into the community. Research has recommended the need for community interventions to minimize medication non-adherence and limit relapse and readmission. Community-based rehabilitation (CBR) directly addresses the need for a concerted approach to post-acute community-based care for people with psychosis in low-resource settings. CBR is a general evidence-based approach for the long-term treatment and support of individuals with a broad range of disabilities in resource-constrained settings that is particularly well suited to address the needs of those with psychosis. CBR aims to improve the quality of life of individuals living with disability by supporting medical care engagement, addressing functional goals, and encouraging social inclusion within their families and communities. CBR is amenable to delivery by a range of personnel and involves collaboration between caregivers, community members, and available public sector services to facilitate the rehabilitation of patients. Accordingly, in this protocol the investigators will pilot-test an adaptation of the evidence-based Community-Based Rehabilitation (CBR) treatment model specifically to address the needs of community-dwelling individuals with psychosis in Malawi. Specifically, investigators will complete a pilot randomized controlled trial to evaluate the feasibility, acceptability, fidelity, and preliminary effectiveness of the adapted CBR treatment model. This work will provide a critical advance in establishing the evidence base for community-based treatment models for people living with psychosis outside of the context of acute inpatient stabilization so as to enhance rehabilitation, functioning, and quality of life.
Interventions
BEHAVIORALEnhanced Usual Care
Participants randomized to usual care will continue to receive their standard clinical care at Queen Elizabeth Central Hospital (QECH) as previously. The clinical team will be provided a summary of the results of the eligibility assessment, specifically an interpretation of the scores on the symptomatology and disability scales with any relevant clinical recommendations. These individuals will receive no home-based services.
BEHAVIORALAdapted ENHANCE Intervention
Participants randomized to the intervention arm will receive community-based rehabilitation (CBR) delivered by the Queen Elizabeth Central Hospital (QECH) clinical team of psychiatric nurses. The ENHANCE CBR intervention will consist of nurse-delivered home visits over approximately a 12-month period with decreasing intensity, with approximately weekly visits for an initial phase of 2-4 months; biweekly visits for an intermediate phase of 4-6 months; and monthly for a final transition phase of 3-4 months. The exact schedule and duration of each phase will be individualized by the nurse to the participant based on the participant's initial presentation and their response during the intervention. The intervention team will deliver intervention content with the participant and/or family members and caregivers as appropriate to the module.
Sponsors
University of North Carolina, Chapel Hill
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Two-arm individually randomized trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
for PWLE: * Current outpatient at Queen Elizabeth Central Hospital psychiatry clinic * Age 18 or older * Diagnosis of schizophrenia spectrum disorder or clinical presentation of symptoms of hallucinations, delusions or thought disorder that persisted for longer than one month and are accompanied by significant functional impairment * Resident in Blantyre District * Not planning to relocate out of Blantyre District in next 12 months * Has a primary caregiver willing to participate in the study * Has current elevated symptoms or poor functioning as demonstrated by one or more of: Positive and Negative Symptoms Scale score ≥58 WHO Disability Assessment Schedule 2.0 score ≥35 Clinical Global Impression Severity score ≥2 (at least mildly ill) Inclusion Criteria for Caregivers: * Is a current caregiver for an eligible and consenting patient participant. * Age 18 or older * Resident in Blantyre District * Not planning to relocate out of Blantyre District in next 12 months
Exclusion criteria
for PWLE: * Not a current outpatient at Queen Elizabeth Central Hospital psychiatry clinic * Not Age 18 or older * No diagnosis of schizophrenia spectrum disorder or clinical presentation of symptoms of hallucinations, delusions or thought disorder that persisted for longer than one month and are accompanied by significant functional impairment * Not a resident in Blantyre District * Planning to relocate out of Blantyre District in next 12 months * Does not have a primary caregiver willing to participate in the study * Does not have current elevated symptoms or poor functioning as demonstrated by one or more of: Positive and Negative Symptoms Scale score ≥58 WHO Disability Assessment Schedule 2.0 score ≥35 Clinical Global Impression Severity score ≥2 (at least mildly ill)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Approached to Meet Enrollment (Recruitment Feasibility) | Baseline | 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. |
| Proportion of Participants Retained in the Study (Retention Feasibility) | 12 months | 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). |
| Number of Participants Who Found the Intervention Helpful (Intervention Acceptability) | Conclusion of study, Month 12 | 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. |
| Number of Intervention Participants Who Completed All Intervention Phases (Intervention Attendance Fidelity) | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Functioning | 12 months | 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 Based on Short-Form 8 Measure | 12 months | 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 PANSS Total Score From Baseline | Baseline,12 months | 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 | 12 months | 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 | 12 months | 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 | 12 months | 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 | 12 months | 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. |
Countries
Malawi
Contacts
PRINCIPAL_INVESTIGATORBrian Pence, PhD, MPH
University of North Carolina, Chapel Hill
Participant flow
Recruitment details
Study recruitment began in December 2023. Recruitment occurred in Queen Elizabeth Central Hospital (QECH) in Blantyre, Malawi.
Pre-assignment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous Caregivers | 43.7 Years STANDARD_DEVIATION 15.5 |
| Age, Continuous Participants With Psychosis | 38.1 Years STANDARD_DEVIATION 12.4 |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Caregivers Female | 42 Participants |
| Sex: Female, Male Caregivers Male | 16 Participants |
| Sex: Female, Male Participants With Psychosis Female | 8 Participants |
| Sex: Female, Male Participants With Psychosis Male | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 30 | 1 / 30 |
| other Total, other adverse events | 5 / 30 | 5 / 30 |
| serious Total, serious adverse events | 1 / 30 | 1 / 30 |
Outcome results
None listed