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NCT Number: NCT05703711

Combining mHealth and Nurse-delivered Care to Improve the Outcomes of People With Serious Mental Illness in West Africa

In West Africa, most people with serious mental illness receive care from traditional or faith healers at prayer camps. The stepped-wedge cluster randomized trial aims to evaluate the effectiveness of a dual-pronged intervention package comprised of a mobile health program designed to train healers to deliver evidence-based psychosocial interventions combined with pharmacotherapy delivered directly to the patients at their prayer camps via a visiting nurse in Ghana.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Ghana

Accra, GP4236, Ghana

Location status: Recruiting

Location contact

Angela Ofori-Atta, PhD

CONTACT

About this study

The study involves deployment of an intervention in Ghanian prayer camps where traditional and faith healers provide care for people with mental illness. The intervention has two components: a visiting nurse that provides medications to patients staying at the prayer camps combined with a smartphone app called M-Healer that is used by the staff working at the camps. The app is designed to provide them with training on how to deliver some psychosocial interventions, monitor the health and well-being of their patients, and protect human rights at the camps.

The stepped-wedge cluster randomized study design involves all participant groups beginning the trial receiving enhanced usual care with random sequential crossover of groups to the experimental condition until all groups have been exposed to the full intervention. Throughout the study, participant data will be collected at baseline, mid-treatment, and post-treatment. Following study completion, the intervention will be evaluated by comparing changes in psychiatric symptoms of participants from baseline to post-treatment.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Aged 18 years or older
  • Speaks Twi or English
  • Current inpatient staying at a study prayer camp
  • A diagnosis of psychosis, mania, or depression

Exclusion criteria

  • Serious physical illness or in need of urgent medical attention

Treatment and study plan

mHealer

Behavioral

MHealer is a software application installed on smartphones that provides psychosocial treatment support and patient condition tracking.

Primary outcomes

  1. Psychiatric symptoms

    Time frame: Baseline, 4 weeks, 8 weeks

    Change in psychiatric symptoms of study participants as measured by the Brief Psychiatric Rating Scale

  2. Depressive symptoms

    Time frame: Baseline, 4 weeks, 8 weeks

    Change in depressive symptoms of participants as measured by the Patient Health Questionnaire-9

Study contacts

Contact information is provided by the study sponsor or research team.

Alexa Beaulieu, MPH

CONTACT

[email protected]

253-261-8661

Dror Ben-Zeev, PhD

CONTACT

[email protected]

206-685-9655

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jan 30, 2023
Registry last updated
Jul 25, 2024

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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