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Rahman, Atif, Malik, Abid, Atif, Najia, Nazir, Huma, Zaidi, Ahmed, Nisar, Anum, Waqas, Ahmed, Sharif, Maria, Chen, Tao, Wang, Duolao 
ORCID: https://orcid.org/0000-0003-2788-2464 and Sikander, Siham
(2023)
'Technology-assisted cognitive-behavior therapy delivered by peers versus standard cognitive behavior therapy delivered by community health workers for perinatal depression: study protocol of a cluster randomized controlled non-inferiority trial'. Trials, Vol 24, Issue 1, e555.
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13063_2023_Article_7581.pdf - Published Version Available under License Creative Commons Attribution. Download (1MB) | Preview |
Abstract
Background:
The lack of trained mental health professionals is a key barrier to scale-up of evidence-based psychological interventions in low and middle-income countries. We have developed an app that allows a peer with no prior experience of health-care delivery to deliver the cognitive therapy-based intervention for perinatal depression, the Thinking Healthy Programme (THP). This trial aims to assess the effectiveness and cost-effectiveness of this Technology-assisted peer-delivered THP versus standard face-to-face Thinking Healthy Programme delivered by trained health workers.
Methods:
We will employ a non-inferiority stratified cluster randomized controlled trial design comparing the two formats of intervention delivery. A total of 980 women in the second or third trimester of pregnancy with a diagnosis of Major Depressive Episode, evaluated with the Structured Clinical Interview for DSM-V Disorders (SCID), will be recruited into the trial. The unit of randomization will be 70 village clusters randomly allocated in a 1:1 ratio to the intervention and control arms. The primary outcome is defined as remission from major depressive episode at 3 months postnatal measured with the SCID. Data will also be collected on symptoms of anxiety, disability, quality of life, service use and costs, and infant-related outcomes such as exclusive breastfeeding and immunization rates. Data will be collected on the primary outcome and selected secondary outcomes (depression and anxiety scores, exclusive breastfeeding) at 6 months postnatal to evaluate if the improvements are sustained in the longer-term. We are especially interested in sustained improvement (recovery) from major depressive episode.
Discussion:
This trial will evaluate the effectiveness and cost-effectiveness of a technology-assisted peer-delivered cognitive behavioral therapy-based intervention in rural Pakistan. If shown to be effective, the novel delivery format could play a role in reducing the treatment gap for perinatal depression and other common mental disorders in LMIC.
Trial registration:
The trial was registered at Clinicaltrials.gov (NCT05353491) on 29 April 2022.
| Item Type: | Article |
|---|---|
| Subjects: | W General Medicine. Health Professions > W 82 Biomedical technology (General) WY Nursing > WY 157.3 Maternal-child nursing. Neonatal nursing. Perinatal nursing |
| Faculty: Department: | Clinical Sciences & International Health > Clinical Sciences Department |
| Digital Object Identifer (DOI): | https://doi.org/10.1186/s13063-023-07581-w |
| SWORD Depositor: | JISC Pubrouter |
| Depositing User: | JISC Pubrouter |
| Date Deposited: | 31 Aug 2023 08:45 |
| Last Modified: | 31 Aug 2023 08:45 |
| URI: | https://archive.lstmed.ac.uk/id/eprint/23024 |
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