Task sharing of a psychological intervention for maternal depression in Khayelitsha, South Africa: study protocol for a randomized controlled trial

Autor: Simone Honikman, Atalay Alem, Ashraf Kagee, John A. Joska, Graham Thornicroft, Memory Nyatsanza, Landon Myer, Judith K. Bass, Martin Prince, Mark Tomlinson, Ezra Susser, Michael J Dewey, Crick Lund, Inge Petersen, Marguerite Schneider, Paul Bolton, Dan J. Stein, Thandi Davies, Arvin Bhana
Přispěvatelé: Department of Psychiatry and Mental Health, Faculty of Health Sciences
Rok vydání: 2014
Předmět:
Counseling
Research design
Inservice Training
Time Factors
Cost effectiveness
Cost-Benefit Analysis
Psychological intervention
Medicine (miscellaneous)
Severity of Illness Index
law.invention
South Africa
Study Protocol
Hamilton depression rating scale
0302 clinical medicine
Clinical Protocols
Randomized controlled trial
Pregnancy
law
Surveys and Questionnaires
Pharmacology (medical)
Community Health Services
030212 general & internal medicine
Community Health Workers
education.field_of_study
Depression
Maternal depression
Health Care Costs
Intention to Treat Analysis
3. Good health
Treatment Outcome
Research Design
Workforce
Female
Mental Health Services
Social Work
medicine.medical_specialty
Population
Mothers
03 medical and health sciences
medicine
Humans
Task sharing
education
Psychiatry
Patient Care Team
Psychiatric Status Rating Scales
business.industry
Public health
Mental health
030227 psychiatry
Pregnancy Complications
Family medicine
Edinburgh Postnatal Depression Scale
Linear Models
Cost-effectiveness
business
Zdroj: Trials
ISSN: 1745-6215
0197-7326
Popis: Background: Maternal depression carries a major public health burden for mothers and their infants, yet there is a substantial treatment gap for this condition in low-resourced regions such as sub-Saharan Africa. To address this treatment gap, the strategy of “task sharing” has been proposed, involving the delivery of interventions by non-specialist health workers trained and supervised by specialists in routine healthcare delivery systems. Several psychological interventions have shown benefit in treating maternal depression, but few have been rigorously evaluated using a task sharing approach. The proposed trial will be the first randomised controlled trial (RCT) evaluating a task sharing model of delivering care for women with maternal depression in sub-Saharan Africa. The objective of this RCT is to determine the effectiveness and cost-effectiveness of a task sharing counseling intervention for maternal depression in South Africa. Methods/Design: The study is an individual-level two-arm RCT. A total of 420 depressed pregnant women will be recruited from two ante-natal clinics in a low-income township area of Cape Town, using the Edinburgh Postnatal Depression Scale to screen for depression; 210 women will be randomly allocated to each of the intervention and control arms. The intervention group will be given six sessions of basic counseling over a period of 3 to 4 months, provided by trained community health workers (CHW)s. The control group will receive three monthly phone calls from a CHW trained to conduct phone calls but not basic counseling. The primary outcome measure is the 17-Item Hamilton Depression Rating Scale (HDRS-17). The outcome measures will be applied at the baseline assessment, and at three follow-up points: 1 month before delivery, and 3 and 12 months after delivery. The primary analysis will be by intention-to-treat and secondary analyses will be on a per protocol population. The primary outcome measure will be analyzed using linear regression adjusting for baseline symptom severity measured using the HDRS-17. Discussion: The findings of this trial can provide policy makers with evidence regarding the effectiveness and cost-effectiveness of structured psychological interventions for maternal depression delivered by appropriately trained and supervised non-specialist CHWs in sub-Saharan Africa. Trial registration Clinical Trials (ClinicalTrials.gov): NCT01977326 , registered on 24/10/2013; Pan African Clinical Trials Registry ( http://www.pactr.org ): PACTR201403000676264 , registered on 11/10/2013.
Databáze: OpenAIRE
Externí odkaz: