Evaluating the Clinical Cost-effectiveness of Two Primary Mental Health Service Frameworks in Yogyakarta, Indonesia

NCT02700490 | Completed

• 1 other identifier: PRE.2015.108
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a cluster randomised controlled trial, which aims to examine the short-term strategy of addressing treatment gap through increasing primary mental health service capacity. This study aims to compare after 6 months and 12 months, the effectiveness of a specialist model of mental health care and an enhanced usual care (task-sharing) framework, in terms of reducing mental health symptoms, reducing disability, and improving quality of life, as well as the health services costs (and potentially societal costs) associated with these outcomes in 400 patients.

Conditions

Mental Disorders

Outcome Measures

Primary Outcomes (2)

• Change in Health of Nations Outcomes Scale (HoNOS) score from baseline

  Measures health and social functioning of participants

  Baseline, 6 months and 12 months

• Change in Clinical Interview Schedule Revised (CIS-R) score from baseline

  Measures the presence and severity of psychiatric symptoms

  Baseline, 6 months and 12 months

Secondary Outcomes (3)

• Change in WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) score from baseline

  Baseline, 6 months and 12 months

• Change in European Quality of Life Scale (EQ-5D) score from baseline

  Baseline, 6 months and 12 months

• Utility of service as measured by Client Service Receipt Inventory (CSRI)

  Baseline, 6 months and 12 months

Study Arms (2)

Specialist

ACTIVE COMPARATOR

Assessment and treatment of common mental disorders by a clinical psychologist in primary care facilities.

Behavioral: Psychotherapy

Enhanced Usual Care

EXPERIMENTAL

Assessment and treatment of common mental disorders by a general practitioner and nurse practitioner, who have been trained in the WHO mhGap manual, in primary care facilities.

Behavioral: Psychotherapy

Interventions

Psychotherapy BEHAVIORAL

Behaviour Therapy or Cognitive Behaviour Therapy which forms "service as usual" in primary care centres in Indonesia.

Enhanced Usual Care; Specialist

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants are adults who meet the screening criteria for depression and anxiety on the self-report General Health Questionnaire (GHQ-12)

You may not qualify if:

• Potential participants who are currently receiving treatment for any mental health disorders will not be invited to participate in the study.

Sponsors & Collaborators

• University of Cambridge: lead
• Universita di Verona: collaborator
• Gadjah Mada University: collaborator

Study Sites (1)

Centre for Public Mental Health

Yogyakarta, D.I Yogyakarta, Indonesia

Location

Related Publications (1)

• Anjara SG, Bonetto C, Ganguli P, Setiyawati D, Mahendradhata Y, Yoga BH, Trisnantoro L, Brayne C, Van Bortel T. Can General Practitioners manage mental disorders in primary care? A partially randomised, pragmatic, cluster trial. PLoS One. 2019 Nov 7;14(11):e0224724. doi: 10.1371/journal.pone.0224724. eCollection 2019.

  PMID: 31697724 DERIVED

MeSH Terms

Conditions

Mental Disorders

Interventions

Psychotherapy

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

• Tine Van Bortel

  University of Cambridge

  STUDY DIRECTOR

• Carol Brayne

  University of Cambridge

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: February 25, 2016
• First Posted: March 7, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: October 29, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

ID (1)