Rahman, Atif 
ORCID: 0000-0002-2066-4467, Malik, Abid, Atif, Najia, Nazir, Huma, Zaidi, Ahmed, Nisar, Anum ORCID: 0000-0003-0862-0303, Waqas, Ahmed ORCID: 0000-0002-3772-194X, Sharif, Maria, Chen, Tao, Wang, Duolao et al (show 1 more authors)
(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, 24 (1).
p. 555.
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Abstract
<h4>Background</h4>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.<h4>Methods</h4>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.<h4>Discussion</h4>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.<h4>Trial registration</h4>The trial was registered at Clinicaltrials.gov (NCT05353491) on 29 April 2022.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | Humans, Depressive Disorder, Major, Pregnancy, Quality of Life, Female, Randomized Controlled Trials as Topic, Community Health Workers, Equivalence Trials as Topic, Cognitive Behavioral Therapy |
| Divisions: | Faculty of Health and Life Sciences Faculty of Health and Life Sciences > Institute of Population Health |
| Depositing User: | Symplectic Admin |
| Date Deposited: | 04 Sep 2023 08:14 |
| Last Modified: | 15 Sep 2023 10:30 |
| DOI: | 10.1186/s13063-023-07581-w |
| Related URLs: | |
| URI: | https://livrepository.liverpool.ac.uk/id/eprint/3172500 |
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