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Completed

NCT Number: NCT04327843

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

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.

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Key information

Conditions

Schizophrenia Behavior Health Behavior Medication Adherence Medication Nonadherence Mental Disorders Patient Acceptance of Health Care Patient Compliance Psychotic Disorders Schizo Affective Disorder Schizophrenia Spectrum and Other Psychotic Disorders Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

MUHAS

Dar es Salaam, Tanzania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Customized Adherence Enhancement

Behavioral

Customized Adherence Enhancement (CAE): CAE targets key areas relevant to adherence in chronic psychotic disorders (CPD): 1.) inadequate understanding of mental disorder, 2.) lack of adequate medication-taking routines, 3.) poor communication with care providers and 4.) substance use which interferes with adherence and recovery. CAE delivered components are selected based upon findings from the ROMI and AMSQ. CAE will be delivered in approximately 8 sessions by a nurse interventionist, ideally at the same time that the long-acting injectable (LAI) is administered.The intervention is guided by a detailed manual and uses components and resources that are available in lower- and middle-income countries (LMICs). Social worker interventionists will be trained to deliver CAE-L.

Other names: CAE

Haloperidol Decanoate

Drug

Long-acting injectable (LAI): Patients on oral haloperidol will be switched to haloperidol decanoate per manufacturer's package insert. Individuals not on antipsychotic medication at the time of screening assessment or who are on a different antipsychotic medication, will receive an oral tolerance test (OTT) consisting of up to 14 days of oral haloperidol 2-5 mg once or twice daily. If the OTT suggests good tolerability, the participant will then receive LAI (haloperidol decanoate) intramuscularly after completion of baseline assessments. Dosing of LAI will be as clinically indicated using conservative dosing to minimize drug-related adverse effects. In the CWRU studies, mean end-point dose of haloperidol decanoate was 68.0 mg, SD 21.1, Range 50-100 mg/monthly injection. It is anticipated that patients will continue on the same dose for 6 months, although dose changes will be permitted based upon clinical status. Each study participant will receive up to 8 injections during the study.

Other names: Haldol Decanoate

Primary outcomes

  1. Tablets Routine Questionnaire (TRQ)

    Time frame: 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).

  2. Long-Acting Injectable Adherence (LAI Adherence): Count of Participants Who Received All LAI Injections:

    Time frame: 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 outcomes

  1. Drug Attitude Inventory (DAI)

    Time frame: 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.

  2. Brief Psychiatric Rating Scale (BPRS)

    Time frame: 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.

  3. Clinical Global Impressions (CGI)

    Time frame: Baseline to 6 month visit

    The minimum possible score is 1 and the maximum score is 7. A higher score implies a worse condition.

  4. Social and Occupational Functioning Scale (SOFAS)

    Time frame: 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.

  5. Body Mass Index

    Time frame: Baseline to Month 6(week 25)

    Body Mass Index kg/m^2 of participants

  6. ESRS-A Parkinsonism

    Time frame: 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.

  7. ESRS-A Dystonia

    Time frame: 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.

  8. ESRS-A Dyskinesia

    Time frame: 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.

  9. ESRS-A Akathisia

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Case Western Reserve University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Reducing the Burden of Chronic Psychotic Disorders in Tanzania

Acronym: CAPACITY

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 31, 2020
Registry last updated
Oct 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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