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
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 the...
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| Format: | Article |
| Language: | English |
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BMC
2023-08-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-023-07581-w |
| _version_ | 1797451632497131520 |
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| author | Atif Rahman Abid Malik Najia Atif Huma Nazir Ahmed Zaidi Anum Nisar Ahmed Waqas Maria Sharif Tao Chen Duolao Wang Siham Sikander |
| author_facet | Atif Rahman Abid Malik Najia Atif Huma Nazir Ahmed Zaidi Anum Nisar Ahmed Waqas Maria Sharif Tao Chen Duolao Wang Siham Sikander |
| author_sort | Atif Rahman |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-09T14:56:29Z |
| format | Article |
| id | doaj.art-bd49954fa3ea4d5987d17e772632b34a |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-03-09T14:56:29Z |
| publishDate | 2023-08-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-bd49954fa3ea4d5987d17e772632b34a2023-11-26T14:09:02ZengBMCTrials1745-62152023-08-0124111510.1186/s13063-023-07581-wTechnology-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 trialAtif Rahman0Abid Malik1Najia Atif2Huma Nazir3Ahmed Zaidi4Anum Nisar5Ahmed Waqas6Maria Sharif7Tao Chen8Duolao Wang9Siham Sikander10Department of Primary Care and Mental Health, Institute of Population Health, University of LiverpoolHealth Services AcademyHuman Development Research FoundationHuman Development Research FoundationHuman Development Research FoundationHuman Development Research FoundationDepartment of Primary Care and Mental Health, Institute of Population Health, University of LiverpoolHuman Development Research FoundationUniversity of YorkLiverpool School of Tropical MedicineDepartment of Primary Care and Mental Health, Institute of Population Health, University of LiverpoolAbstract 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.https://doi.org/10.1186/s13063-023-07581-wPerinatal depressionPsychosocial interventionCognitive-behavioral therapyThinking Healthy ProgrammeDigital interventionTechnology |
| spellingShingle | Atif Rahman Abid Malik Najia Atif Huma Nazir Ahmed Zaidi Anum Nisar Ahmed Waqas Maria Sharif Tao Chen Duolao Wang Siham Sikander 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 Perinatal depression Psychosocial intervention Cognitive-behavioral therapy Thinking Healthy Programme Digital intervention Technology |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Perinatal depression Psychosocial intervention Cognitive-behavioral therapy Thinking Healthy Programme Digital intervention Technology |
| url | https://doi.org/10.1186/s13063-023-07581-w |
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