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Thinking Healthy Program-Technology Assisted (THP-TA) (THP-TA)

Primary Purpose

Perinatal Depression, Depression, Postpartum

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Technology assisted Thinking Healthy Program (THP-TA)
Standard Thinking Healthy Program
Sponsored by
Human Development Research Foundation, Pakistan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perinatal Depression focused on measuring Perinatal depression, Perinatal anxiety, perinatal mental health conditions, electronic CBT, CBT, task shifting, low-resourced settings, task sharing, Thinking Healthy Programme, LMIC, Technology-assisted, peers, community health workers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Pregnant women with current major depressive episode in their second or third trimester (4 to 8 months of pregnancy).
  2. Aged 18 years and above
  3. Intent to stay in the study area for at least 1 year.

Exclusion Criteria:

  1. Women requiring inpatient care for any reason (medical or psychiatric) as determined by their primary health care professional
  2. Those who do not comprehend Urdu language will be excluded.

Sites / Locations

  • Human Development Research FoundationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Technology assisted Thinking Healthy Program delivered by peers

Standard Thinking Healthy Program delivered by community health workers

Arm Description

A technology adapted version of the Thinking Healthy Program (THP) delivered by peers using multimedia android based app. The bespoke android app leverages human-centered design and makes use of 2-d videos demonstrating narrative scripts delivered by culturally appropriate animated avatars representing depressed mothers, families, peers and mental health experts. It is designed as a low intensity psychosocial multicomponent intervention based on cognitive behavioral approaches. The THP improves depression through psychoeducation, behavior activation, thought challenging, improving problem solving skills and by activating social support networks. The intervention program comprises of 8 sessions delivered by trained peers.

The Thinking Healthy Programme (THP) is a CBT-based manualised paper version of the intervention targeting women with perinatal depression in low socioeconomic settings. The CBT techniques include guided discovery using illustrated brief vignettes, behavioural activation, and problem solving. Non-specific techniques include empathic listening and promoting social support from key family members for the mother in negotiating challenges during the perinatal period. This intervention programme is paper based utilizing reference manual, health calendar and job aid as tools for delivering content. The intervention employs these techniques to improve outcomes in three areas: maternal well-being, mother-infant interaction and relationship with significant others. The intervention consists of 8 core sessions starting in the second or third trimester of pregnancy and continuing to 3 months postnatal.

Outcomes

Primary Outcome Measures

Remission rates of perinatal depression
Remission rates from perinatal depression among the trial participants will be based on clinical diagnostic criteria based on the Structured Clinical Interview for the DSM-IV Axis (SCID) module. The SCID will be employed at baseline and 3 months postnatal.

Secondary Outcome Measures

Sustained remission rates of perinatal depression
Sustained remission rates from perinatal depression among the trial participants will be based on clinical diagnostic criteria based on the Structured Clinical Interview for the DSM-IV Axis (SCID) module, assessed at baseline, 3 and 6 months postnatal.
Change in severity of perinatal depressive symptoms
Severity of perinatal depressive symptoms will be measured using the Patient Health Questionnaire-9 items assessed at baseline, 3 months and 6 months postnatal. Score on this scale ranges from 0 to 27, with higher scores indicating increased severity.
Change in severity of perinatal anxiety symptoms
Severity of perinatal anxiety symptoms will be measured using the Generalized anxiety Disorder-7 scale assessed at baseline, 3 months and 6 months postnatal. Score on this scale ranges from 0 to 21, with higher scores indicating increased severity.
Change in maternal Quality of Life
Change in maternal quality of life will be measured using the EuroQuality of Life scale (EQ-5D-3L), at baseline, 3 months and 6 months postnatal. It is a valid and reliable scale to quantify health status across 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Change in disability using the World Health Organization Disability Assessment Schedule 2.0
This World Health Organization Disability Assessment Schedule 2.0 questionnaire assesses disability due to health conditions or illnesses (chronic or acute) including mental and emotional health problems. It is a valid and reliable instrument that generates domain-specific scores for six different functioning domains: i) cognition ii) mobility iii) self-care iv) getting along v) life activities (household and work/school) and vi) participation. It will be employed at baseline, 3 and 6 months postnatal.
Service use and costs
Service use will be measured using Client Service Receipt Inventory (CSRI), including costs of healthcare services used, details and costs of medications and wider health service utilization and economic costs at 3 months and 6 months postnatal.
Infant nutrition/breastfeeding
Using 24-hour recall WHO breastfeeding practices tool, we will quantify percentage of infants being exclusively breastfed at 3 months and 6 months postnatal.
Family planning practices
To ascertain family planning practices, categorical questions will be asked regarding the use of contraception during the postpartum period.
Infant Immunization Status
Immunization status of the infant will be assessed using a categorical question assessing completely or incompletely immunized as per the Expanded Programme on Immunization program in Pakistan, at 3 months and 6 months postnatal.
Maternal Social support
Multidimensional Scale of Perceived Social Support (MSPSS) will be used to assess the perceived levels of social support among the intervention recipients at baseline, 3 months and 6 months postnatal, from three sources: family, friends and significant other. It comprises of 12 items, scores on which can be summed together with higher scores corresponding to better social support.
Parental time spent in play with the infant
Parental time spent in play with the infant will be assessed at 3 months and 6 months postnatal.
Diarrheal episodes among infants
Number of episodes of diarrheal episodes among infants will be assessed using the WHO criteria and definitions, at 3 months and 6 months postnatal
Acute upper respiratory tract infections among infants
Number of episodes of acute upper respiratory tract infections among infants will be assessed using the WHO criteria and definitions, at 3 months and 6 months postnatal

Full Information

First Posted
March 28, 2022
Last Updated
August 11, 2022
Sponsor
Human Development Research Foundation, Pakistan
Collaborators
Shifa Tameer-e-Millat University, University of Liverpool
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1. Study Identification

Unique Protocol Identification Number
NCT05353491
Brief Title
Thinking Healthy Program-Technology Assisted (THP-TA)
Acronym
THP-TA
Official Title
Technology-assisted Cognitive-behaviour Therapy Delivered by Peers Versus Standard Cognitive Behaviour Therapy Delivered by Community Health Workers for Perinatal Depression: A Cluster Randomised Controlled Non-inferiority Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 13, 2022 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Human Development Research Foundation, Pakistan
Collaborators
Shifa Tameer-e-Millat University, University of Liverpool

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Background The Thinking Healthy Program (THP) is an evidence based task-shifted low intensity psychosocial intervention, recommended by the World Health Organization for the treatment of perinatal depression. The investigators developed a technology-assisted version of Thinking Healthy Program (THP-TA) which allows peers to deliver the THP, while ensuring minimal resources for training of delivery agents and ensuring adequate fidelity. Method This is a non-inferiority, pragmatic cluster randomized controlled trial designed to test the primary hypothesis that technology assisted delivery of THP is not worse than THP intervention delivered by community health workers, in increasing perinatal depression remission rates at 3 months postnatal. In addition, this study will also test the effectiveness of the THP-TA in improving recovery from perinatal depression at 6 months postpartum, quality of life and social support. This study also aims to evaluate the cost-effectiveness of the THP-TA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perinatal Depression, Depression, Postpartum
Keywords
Perinatal depression, Perinatal anxiety, perinatal mental health conditions, electronic CBT, CBT, task shifting, low-resourced settings, task sharing, Thinking Healthy Programme, LMIC, Technology-assisted, peers, community health workers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
980 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Technology assisted Thinking Healthy Program delivered by peers
Arm Type
Experimental
Arm Description
A technology adapted version of the Thinking Healthy Program (THP) delivered by peers using multimedia android based app. The bespoke android app leverages human-centered design and makes use of 2-d videos demonstrating narrative scripts delivered by culturally appropriate animated avatars representing depressed mothers, families, peers and mental health experts. It is designed as a low intensity psychosocial multicomponent intervention based on cognitive behavioral approaches. The THP improves depression through psychoeducation, behavior activation, thought challenging, improving problem solving skills and by activating social support networks. The intervention program comprises of 8 sessions delivered by trained peers.
Arm Title
Standard Thinking Healthy Program delivered by community health workers
Arm Type
Active Comparator
Arm Description
The Thinking Healthy Programme (THP) is a CBT-based manualised paper version of the intervention targeting women with perinatal depression in low socioeconomic settings. The CBT techniques include guided discovery using illustrated brief vignettes, behavioural activation, and problem solving. Non-specific techniques include empathic listening and promoting social support from key family members for the mother in negotiating challenges during the perinatal period. This intervention programme is paper based utilizing reference manual, health calendar and job aid as tools for delivering content. The intervention employs these techniques to improve outcomes in three areas: maternal well-being, mother-infant interaction and relationship with significant others. The intervention consists of 8 core sessions starting in the second or third trimester of pregnancy and continuing to 3 months postnatal.
Intervention Type
Behavioral
Intervention Name(s)
Technology assisted Thinking Healthy Program (THP-TA)
Intervention Description
A technology adapted version of the Thinking Healthy Program (THP) delivered by peers using multimedia android based app.
Intervention Type
Behavioral
Intervention Name(s)
Standard Thinking Healthy Program
Intervention Description
This intervention paper-based manual delivered by lady health workers ie government employed community health workers with health training background.
Primary Outcome Measure Information:
Title
Remission rates of perinatal depression
Description
Remission rates from perinatal depression among the trial participants will be based on clinical diagnostic criteria based on the Structured Clinical Interview for the DSM-IV Axis (SCID) module. The SCID will be employed at baseline and 3 months postnatal.
Time Frame
3 months postnatal
Secondary Outcome Measure Information:
Title
Sustained remission rates of perinatal depression
Description
Sustained remission rates from perinatal depression among the trial participants will be based on clinical diagnostic criteria based on the Structured Clinical Interview for the DSM-IV Axis (SCID) module, assessed at baseline, 3 and 6 months postnatal.
Time Frame
3 months and 6 months postnatal
Title
Change in severity of perinatal depressive symptoms
Description
Severity of perinatal depressive symptoms will be measured using the Patient Health Questionnaire-9 items assessed at baseline, 3 months and 6 months postnatal. Score on this scale ranges from 0 to 27, with higher scores indicating increased severity.
Time Frame
3 months and 6 months postnatal
Title
Change in severity of perinatal anxiety symptoms
Description
Severity of perinatal anxiety symptoms will be measured using the Generalized anxiety Disorder-7 scale assessed at baseline, 3 months and 6 months postnatal. Score on this scale ranges from 0 to 21, with higher scores indicating increased severity.
Time Frame
3 months and 6 months postnatal
Title
Change in maternal Quality of Life
Description
Change in maternal quality of life will be measured using the EuroQuality of Life scale (EQ-5D-3L), at baseline, 3 months and 6 months postnatal. It is a valid and reliable scale to quantify health status across 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Time Frame
3 months and 6 months postnatal
Title
Change in disability using the World Health Organization Disability Assessment Schedule 2.0
Description
This World Health Organization Disability Assessment Schedule 2.0 questionnaire assesses disability due to health conditions or illnesses (chronic or acute) including mental and emotional health problems. It is a valid and reliable instrument that generates domain-specific scores for six different functioning domains: i) cognition ii) mobility iii) self-care iv) getting along v) life activities (household and work/school) and vi) participation. It will be employed at baseline, 3 and 6 months postnatal.
Time Frame
3 months and 6 months postnatal
Title
Service use and costs
Description
Service use will be measured using Client Service Receipt Inventory (CSRI), including costs of healthcare services used, details and costs of medications and wider health service utilization and economic costs at 3 months and 6 months postnatal.
Time Frame
Pregnancy through to 6 months postnatal
Title
Infant nutrition/breastfeeding
Description
Using 24-hour recall WHO breastfeeding practices tool, we will quantify percentage of infants being exclusively breastfed at 3 months and 6 months postnatal.
Time Frame
3 months and 6 months postnatal
Title
Family planning practices
Description
To ascertain family planning practices, categorical questions will be asked regarding the use of contraception during the postpartum period.
Time Frame
3 months and 6 months postnatal
Title
Infant Immunization Status
Description
Immunization status of the infant will be assessed using a categorical question assessing completely or incompletely immunized as per the Expanded Programme on Immunization program in Pakistan, at 3 months and 6 months postnatal.
Time Frame
3 months and 6 months postnatal
Title
Maternal Social support
Description
Multidimensional Scale of Perceived Social Support (MSPSS) will be used to assess the perceived levels of social support among the intervention recipients at baseline, 3 months and 6 months postnatal, from three sources: family, friends and significant other. It comprises of 12 items, scores on which can be summed together with higher scores corresponding to better social support.
Time Frame
3 months and 6 months postnatal
Title
Parental time spent in play with the infant
Description
Parental time spent in play with the infant will be assessed at 3 months and 6 months postnatal.
Time Frame
3 months and 6 months postnatal
Title
Diarrheal episodes among infants
Description
Number of episodes of diarrheal episodes among infants will be assessed using the WHO criteria and definitions, at 3 months and 6 months postnatal
Time Frame
3 months and 6 months postnatal
Title
Acute upper respiratory tract infections among infants
Description
Number of episodes of acute upper respiratory tract infections among infants will be assessed using the WHO criteria and definitions, at 3 months and 6 months postnatal
Time Frame
3 months and 6 months postnatal

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pregnant women with current major depressive episode in their second or third trimester (4 to 8 months of pregnancy). Aged 18 years and above Intent to stay in the study area for at least 1 year. Exclusion Criteria: Women requiring inpatient care for any reason (medical or psychiatric) as determined by their primary health care professional Those who do not comprehend Urdu language will be excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Atif Rahman, PhD
Phone
+447794171967
Email
atif.rahman@liverpool.ac.uk
Facility Information:
Facility Name
Human Development Research Foundation
City
Rawalpindi
State/Province
Punjab
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abid Malik, PhD
Phone
+923468544463
Email
abid.malik@hdrfoundation.org

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
After the publication of results focusing on primary and secondary outcomes/endpoints, anonymous data can be made available to researchers who provide a methodologically sound proposal, on request.
Citations:
PubMed Identifier
18790313
Citation
Rahman A, Malik A, Sikander S, Roberts C, Creed F. Cognitive behaviour therapy-based intervention by community health workers for mothers with depression and their infants in rural Pakistan: a cluster-randomised controlled trial. Lancet. 2008 Sep 13;372(9642):902-9. doi: 10.1016/S0140-6736(08)61400-2.
Results Reference
background
PubMed Identifier
30686386
Citation
Sikander S, Ahmad I, Atif N, Zaidi A, Vanobberghen F, Weiss HA, Nisar A, Tabana H, Ain QU, Bibi A, Bilal S, Bibi T, Liaqat R, Sharif M, Zulfiqar S, Fuhr DC, Price LN, Patel V, Rahman A. Delivering the Thinking Healthy Programme for perinatal depression through volunteer peers: a cluster randomised controlled trial in Pakistan. Lancet Psychiatry. 2019 Feb;6(2):128-139. doi: 10.1016/S2215-0366(18)30467-X.
Results Reference
background
PubMed Identifier
30686385
Citation
Fuhr DC, Weobong B, Lazarus A, Vanobberghen F, Weiss HA, Singla DR, Tabana H, Afonso E, De Sa A, D'Souza E, Joshi A, Korgaonkar P, Krishna R, Price LN, Rahman A, Patel V. Delivering the Thinking Healthy Programme for perinatal depression through peers: an individually randomised controlled trial in India. Lancet Psychiatry. 2019 Feb;6(2):115-127. doi: 10.1016/S2215-0366(18)30466-8.
Results Reference
background
PubMed Identifier
31157115
Citation
Rahman A, Akhtar P, Hamdani SU, Atif N, Nazir H, Uddin I, Nisar A, Huma Z, Maselko J, Sikander S, Zafar S. Using technology to scale-up training and supervision of community health workers in the psychosocial management of perinatal depression: a non-inferiority, randomized controlled trial. Glob Ment Health (Camb). 2019 May 16;6:e8. doi: 10.1017/gmh.2019.7. eCollection 2019.
Results Reference
background
PubMed Identifier
32828167
Citation
Maselko J, Sikander S, Turner EL, Bates LM, Ahmad I, Atif N, Baranov V, Bhalotra S, Bibi A, Bibi T, Bilal S, Biroli P, Chung E, Gallis JA, Hagaman A, Jamil A, LeMasters K, O'Donnell K, Scherer E, Sharif M, Waqas A, Zaidi A, Zulfiqar S, Rahman A. Effectiveness of a peer-delivered, psychosocial intervention on maternal depression and child development at 3 years postnatal: a cluster randomised trial in Pakistan. Lancet Psychiatry. 2020 Sep;7(9):775-787. doi: 10.1016/S2215-0366(20)30258-3. Erratum In: Lancet Psychiatry. 2021 Jan;8(1):e1.
Results Reference
background
PubMed Identifier
32090783
Citation
Vanobberghen F, Weiss HA, Fuhr DC, Sikander S, Afonso E, Ahmad I, Atif N, Bibi A, Bibi T, Bilal S, De Sa A, D'Souza E, Joshi A, Korgaonkar P, Krishna R, Lazarus A, Liaqat R, Sharif M, Weobong B, Zaidi A, Zuliqar S, Patel V, Rahman A. Effectiveness of the Thinking Healthy Programme for perinatal depression delivered through peers: Pooled analysis of two randomized controlled trials in India and Pakistan. J Affect Disord. 2020 Mar 15;265:660-668. doi: 10.1016/j.jad.2019.11.110. Epub 2019 Nov 23.
Results Reference
background

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Thinking Healthy Program-Technology Assisted (THP-TA)

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