Thinking Healthy Program-Technology Assisted (THP-TA)

Depression, Postpartum Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05353491
• Other study ID #: UoL001668
• Secondary ID: NIHR200817
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 13, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: March 2024
• Source: Human Development Research Foundation, Pakistan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 980
• Est. completion date: September 30, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asphyxia Neonatorum
• Depression
• Depression, Postpartum
• Depressive Disorder
• Perinatal Depression

Intervention

Behavioral:
• Technology assisted Thinking Healthy Program (THP-TA)
A technology adapted version of the Thinking Healthy Program (THP) delivered by peers using multimedia android based app.
• Standard Thinking Healthy Program
This intervention paper-based manual delivered by lady health workers ie government employed community health workers with health training background.

Locations

Country	Name	City	State
Pakistan	Human Development Research Foundation	Rawalpindi	Punjab

Sponsors (3)

Lead Sponsor	Collaborator
Human Development Research Foundation, Pakistan	Shifa Tameer-e-Millat University, University of Liverpool

Country where clinical trial is conducted

Pakistan, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months postnatal
Secondary	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.	3 months and 6 months postnatal
Secondary	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.	3 months and 6 months postnatal
Secondary	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.	3 months and 6 months postnatal
Secondary	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.	3 months and 6 months postnatal
Secondary	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.	3 months and 6 months postnatal
Secondary	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.	Pregnancy through to 6 months postnatal
Secondary	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.	3 months and 6 months postnatal
Secondary	Family planning practices	To ascertain family planning practices, categorical questions will be asked regarding the use of contraception during the postpartum period.	3 months and 6 months postnatal
Secondary	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.	3 months and 6 months postnatal
Secondary	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.	3 months and 6 months postnatal
Secondary	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.	3 months and 6 months postnatal
Secondary	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	3 months and 6 months postnatal
Secondary	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	3 months and 6 months postnatal