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Recruiting NCT07276321

Preliminary Efficacy of an mHealth Intervention in West Africa

No phase Interventional Schizophrenic Spectrum Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: G-FOCUS, FOCUS.
Who it may be relevant to
Registry conditions: Schizophrenic Spectrum Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Ghana
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

We are conducting a pilot feasibility and preliminary efficacy trial of a digital intervention for serious mental illness in West Africa. Participants will be recruited from a large psychiatric hospital in Ghana and randomized into one of three study conditions: 1) Treatment as usual; 2) FOCUS intervention; 3) G-FOCUS intervention.

Interventions

  • Other G-FOCUS
    A cultural adaption of an evidence-based (USA populations tested) digital tool for serious mental illness
  • Other FOCUS
    An evidence-based (USA populations tested) digital tool for serious mental illness.

Primary outcome measures

  • Patient Health Questionnaire-9 (PHQ-9) [Time frame: Baseline, 6 weeks, 12 weeks]
  • Generalized Anxiety Disorder 7-item (GAD-7) [Time frame: Baseline, 6 weeks, 12 weeks]
  • Revised Green et al Paranoid Thoughts Scale [Time frame: Baseline, 6 weeks, 12 weeks]
  • Hamilton Program for Schizophrenia Voices Questionnaire [Time frame: Baseline, 6 weeks, 12 weeks]

Eligibility criteria

Inclusion criteria

  • Aged 18 years of age or older
  • Speaks English
  • Outpatient receiving care at Accra Psychiatric Hospital
  • Diagnosis of Schizophrenic Spectrum Disorder
  • Owns a mobile device capable of downloading smartphone applications

Exclusion criteria

  • Hearing, vision, or motor impairment that would hamper their ability to participate in data collection
  • Serious intellectual or developmental disability that would hamper their ability to participate in data collection

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Ghana · 1 center
  • Accra Psychiatric Hospital — Accra

Identifiers

NCT: NCT07276321 · STUDY00023050

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗