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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02644902
Other study ID # GCC-THP-TACTS-2015
Secondary ID
Status Completed
Phase N/A
First received December 28, 2015
Last updated February 23, 2017
Start date March 2016
Est. completion date October 2016

Study information

Verified date February 2017
Source Human Development Research Foundation, Pakistan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The Thinking Healthy Program is evidence based psychological intervention, delivered by non-specialists, with proven impact on maternal depression. A major challenge in the scale-up of this intervention, especially where health systems are weak, is providing quality training and supervision at scale. Women living in post-conflict areas are at a higher risk of depression than the general population.The key innovation proposed is the development and evaluation of a technology-assisted cascade training and supervision system to assist scale-up of the Thinking Healthy Programme in a post conflict area of Pakistan.


Description:

The Thinking Healthy Program (THP) is a cognitive behaviour therapy (CBT)-based intervention for maternal depression, delivered by non-specialists.In a recent meta-analysis commissioned by the WHO, THP was shown to have a large effect and has been adopted by the WHO for global dissemination through its mhGAP programme. A major challenge in the scaling up of this evidence-based intervention is the provision of training and supervision at scale, especially in post-conflict areas with weak health systems. The investigators aim to meet this challenge by providing technology based solutions to training and supervision. Building on the organization's previous work in this area, investigators aim to develop Avatar-assisted cascade training and supervision system that includes: (a) a interactive voice response system for phone based assessment to screen depression in the community; (b) a Tablet-based manual , using special characters or avatars allowing standardized training to be delivered without the need for a specialist trainer; and (c) a cascade training model whereby specialists supervise, from distance, the community health worker program supervisors, who in turn, supervise the community health workers (CHW) as part of their normal routine.

The Lady Health Worker (LHW) Programme covers 85% of Pakistan's rural population through 115,000 LHWs . If this study is able to provide a technological solution to the training and supervision of health workers, they have the potential to provide treatment to an estimated 5 million women in rural Pakistan with maternal depression.

Investigators intend conducting the study in District Swat affected by multiple humanitarian crises in recent years. Swat has a population of 1,257,602 persons, 86% of whom live in rural areas with the average household size of 8.8 persons with a low female literacy. The resurgence of the Taliban movement in the Swat Valley of Pakistan since 2004, and the military operations in 2009 and the displacement of residents created a humanitarian crisis in the area. The devastating floods of 2010 put thousands of people out of their homes, and caused destruction to houses, roads, schools and health facilities.The health infrastructure of a post conflict zone like Swat is particularly fragile with the health workers under threat of being attacked, limiting their mobility. Mental health impacts of conflict are often severe and may not be depicted in the national statistics.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date October 2016
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- Lady health workers currently working in Swat district

Exclusion Criteria:

- Physically unwell, lady health workers on leave

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Avatar assisted cascade training
Training of health workers in THP through tablets including avatar characters , and cascaded supervision model.
Specialist led training in THP
Training and supervision of lady health workers by specialists as in original THP

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Human Development Research Foundation, Pakistan Duke University, University of Liverpool

Outcome

Type Measure Description Time frame Safety issue
Primary Competency of health workers in THP skills measured using ENact assessment tool The competency of health workers in the two arms will be measured using ENact assessment tool. Immediately after intervention
Secondary Cost of intervention Cost of intervention and comparative arm will be assessed from data collected during the trial and analyzed after 3 months. 3 months after intervention
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