Reducing the Burden of Chronic Psychotic Disorders in Tanzania (CAPACITY)

Phase 3

Completed

Conditions: Schizophrenia
Schizo Affective Disorder
Medication Nonadherence

Interventions: Behavioral: Customized Adherence Enhancement
Drug: Haloperidol Decanoate

Registration Number: NCT04327843

Lead Sponsor: Case Western Reserve University

Brief Summary: The proposed, three phase project will refine and test a first-ever care approach in SSA that combines LAI with a behavioral program specifically intended to promote medication adherence in chronic psychotic disorders (CPDs). In addition to the novel focus, innovative elements include: 1.) a manualized curriculum that targets specific barriers and facilitators to medication adherence in Tanzanians with CPD, 2.) targeting known, high-risk individuals with CPD (those who miss ≥20% of prescribed antipsychotic medication, and 3.) using existing injection clinic health workers to deliver the adherence promotion program. Strengths include the highly generalizable methods and use of LAIs that are available in low-resource settings.

Detailed Description: In this Phase 3 portion, the study team will select appropriate measures, train staff and build capacity in measure implementation, and finalize the intervention for delivery by healthcare workers. Finally, in a training/proof-of-concept exercise, the healthcare workers will implement the adapted CAE-L in a high-risk sample of Tanzanians with CPD (individuals with schizophrenia or schizoaffective disorder who have had recent medication adherence problems). Taken together, the proposed project has substantial public health importance. It will provide the prerequisite materials, training and infrastructure needed for a prospective trial in reducing CPD burden and improving brain health in Tanzania and other countries in Sub-Saharan Africa.

The focus of this project is on feasibility, patient acceptability, and research capacity-building. Therefore a specific hypothesis is not being tested. The investigators will assess descriptive statistics and change from baseline in the primary and secondary measures using standard pre-post techniques.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 22

Inclusion Criteria

Age 18 and older
Diagnosis of schizophrenia or schizoaffective disorder
Known to have medication treatment adherence problems as identified by the TRQ (20% or more missed medications in past week or past month)
Ability to be rated on psychiatric rating scales
Willingness to take long-acting injectable medication
Able to provide written, informed consent to study participation

Exclusion Criteria

History of allergy or intolerance to haloperidol or haloperidol decanoate
Individuals on long-acting injectable antipsychotic medication immediately prior to study enrollment
Medical condition or illness, which in the opinion of the research psychiatrist, would interfere with the patient's ability to participate in the trial
Physical dependence on substances (alcohol or illicit drugs) likely to lead to withdrawal reaction during the course of the study in the clinical opinion of the treated research psychiatrist
Immediate risk of harm to self or others
Female who is currently pregnant or breastfeeding

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CAE + LAI	Haloperidol Decanoate	Customized Adherence Enhancement (CAE) + Long-Acting Injectable Antipsychotic (LAI)
CAE + LAI	Customized Adherence Enhancement	Customized Adherence Enhancement (CAE) + Long-Acting Injectable Antipsychotic (LAI)

Primary Outcome Measures

Name	Time	Method
Tablets Routine Questionnaire (TRQ)	Change from Baseline to 6 month visit	The TRQ evaluates adherence to medications via a brief self-report instrument that has been validated in populations with bipolar disorder medication adherence. The TRQ identifies nonadherent individuals, defined as those who miss 20-30% or more of their medication in the last week or month. Total scores are represented as a percentage and range from 0 to 100, with higher scores indicating a greater level of nonadherence (higher scores indicate worse adherence to medications).
Long-Acting Injectable Adherence (LAI Adherence): Count of Participants Who Received All LAI Injections:	Baseline to 6 month visit	LAI injection adherence will be determined as a count of participants who received LAI injections at the appropriate time (within 7 days of scheduled time).

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impressions (CGI)	Baseline to 6 month visit	The minimum possible score is 1 and the maximum score is 7. A higher score implies a worse condition.
Brief Psychiatric Rating Scale (BPRS)	Baseline to 6 month visit	The BPRS measures levels of mania. There are 24 items, scored on a 7-point scale ranging from 0 to 6. Total scores range from 0 to 42, with higher scores indicating higher levels of mania.
Social and Occupational Functioning Scale (SOFAS)	Baseline to 6 month visit	The SOFAS measures social and occupational functioning independent of the overall severity of the individual's psychological symptoms. The minimum score is 0 and the maximum score is 100. A higher rating implies a higher level of functioning.
Body Mass Index	Baseline to Month 6(week 25)	Body Mass Index kg/m\^2 of participants
ESRS-A Dyskinesia	Baseline to 6 months(25 weeks)	Extrapyramidal Symptoms Scale-Abbreviated version for Dyskinesia- drug-induced dyskinesia which is repetitive and involuntary movements. Each item is rated on a 4 point scale: 0=absent, 3=severe and higher values indicate greater severity of dyskinesia and worse outcomes.
Drug Attitude Inventory (DAI)	Baseline to 6 month visit	DAI-10 scoring ranges from -10 to +10 with a total score \>0 indicating a positive attitude toward psychiatric medications and a total score of \<0 indicating a negative attitude toward psychiatric medications.
ESRS-A Parkinsonism	Baseline to 6 months(25 weeks)	Extrapyramidal Symptoms Scale-Abbreviated version for Parkinsonism. It looks at drug-induced Parkinsonism which is made up of motor disturbances. Rigidity, tremor, reduced facial expression/speech, impaired gait/posture, postural instability, and bradykinesia. Each item is rated on a 4 point scale: 0=absent, 3=severe. The higher the value the more severe the Parkinsonism and worst outcomes.
ESRS-A Dystonia	Baseline to 6 months(25 weeks)	Extrapyramidal Symptoms Scale-Abbreviated version for dystonia- drug-induced dystonia is a muscle disorder in which movements are jerky or twisting. Due to the 0.00 values at baseline and 25 weeks, unable to perform t-test and get a p value so no statistical analysis section is reported for this Outcome Measure. Each item is rated on a 4 point scale: 0=absent, 3=severe with the higher numbers indicating worse dystonia and worse outcomes.
ESRS-A Akathisia	Baseline to 6 months(25 weeks)	Extrapyramidal Symptoms Scale-Abbreviated version for akathisia- drug-induced akathisia consists of inner restlessness and urge to move. Items are measured on a 4 value scale: 0=absent, 3=severe, and higher values indicate more severe akathisia and worse outcomes.