Perinatal DepressionTHP-TANCT05353491

Thinking Healthy Program-Technology Assisted (THP-TA)

A study testing Technology assisted Thinking Healthy Program (THP-TA) and Standard Thinking Healthy Program in people with Perinatal Depression and Depression, Postpartum, run by Human Development Research Foundation, Pakistan at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Perinatal Depression, Depression, Postpartum
What is being tested?: Technology assisted Thinking Healthy Program (THP-TA) and Standard Thinking Healthy Program
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 980 participants
Where: 1 sitePakistan
Study dates: 13 Jun 2022to 30 Sep 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

Human Development Research Foundation
Rawalpindi, Punjab Province

Other trials in Pakistan

About this study

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

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.

Conditions: Perinatal Depression, Depression, Postpartum
Being tested: Technology assisted Thinking Healthy Program (THP-TA), Standard Thinking Healthy Program
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
Medical subject headings: Depression, Postpartum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05353491
Study group	Role	What they receive
Technology assisted Thinking Healthy Program delivered by peers	Experimental	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. Receives: Behavioral: Technology assisted Thinking Healthy Program (THP-TA)
Standard Thinking Healthy Program delivered by community health workers	Active comparator	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. Receives: Behavioral: Standard Thinking Healthy Program

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 3 months postnatal

Secondary outcomes (13)

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.
Measured: 3 months 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.
Measured: 3 months and 6 months postnatal
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.
Measured: 3 months and 6 months postnatal
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.
Measured: 3 months and 6 months postnatal
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.
Measured: 3 months 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.
Measured: Pregnancy through to 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.
Measured: 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.
Measured: 3 months and 6 months postnatal
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.
Measured: 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.
Measured: 3 months and 6 months postnatal
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.
Measured: 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
Measured: 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
Measured: 3 months and 6 months postnatal

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jun 202230 Sep 2024

First posted29 Apr 2022
Study start13 Jun 2022
Primary completion1 May 2024
Study completion30 Sep 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Perinatal DepressionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 980 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05353491
Sponsor's protocol ID: UoL001668
Other IDs: NIHR200817
Acronym: THP-TA
Status last verified: Nov 2024
First submitted: 28 Mar 2022
Last updated: 22 Nov 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: 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.

Publications

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.
PubMed 18790313
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.
PubMed 30686386
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.
PubMed 30686385
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.
PubMed 31157115
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.
PubMed 32828167
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.
PubMed 32090783
Rahman A, Malik A, Nazir H, Zaidi A, Nisar A, Waqas A, Atif N, Gibbs NK, Luo Y, Sikander S, Wang D. Technology-assisted cognitive-behavioral therapy for perinatal depression delivered by lived-experience peers: a cluster-randomized noninferiority trial. Nat Med. 2025 Jul;31(7):2196-2203. doi: 10.1038/s41591-025-03655-1. Epub 2025 Apr 8.
PubMed 40200057
Rahman A, Malik A, Atif N, Nazir H, Zaidi A, Nisar A, Waqas A, Sharif M, Chen T, Wang D, Sikander S. 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. 2023 Aug 25;24(1):555. doi: 10.1186/s13063-023-07581-w.
PubMed 37626428

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Perinatal Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05353491
Acronym / sponsor ID: THP-TA / UoL001668
Conditions: Perinatal Depression, Depression, Postpartum
Keywords: Perinatal depression, Perinatal anxiety, perinatal mental health conditions, electronic CBT, CBT, task shifting, low-resourced settings, task sharing
Study type: Interventional
Recruitment status: Completed
Enrolment: 980 participants (actual)
Lead sponsor: Human Development Research Foundation, PakistanUniversity, hospital or other
Collaborators: Shifa Tameer-e-Millat University, University of Liverpool
Study start: 13 Jun 2022 (actual)
Primary completion: 1 May 2024 (actual)
Study completion: 30 Sep 2024 (actual)
First posted: 29 Apr 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Background

Method

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Technology assisted Thinking Healthy Program delivered by peers	Experimental	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. 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.
Standard Thinking Healthy Program delivered by community health workers	Active comparator	Behavioral: Standard Thinking Healthy ProgramThe 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.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Behavioural	Technology assisted Thinking Healthy Program delivered by peers
Standard Thinking Healthy ProgramThis intervention paper-based manual delivered by lady health workers ie government employed community health workers with health training background.	Behavioural	Standard Thinking Healthy Program delivered by community health workers

Primary outcome

Remission rates of perinatal depression
Time frame: 3 months postnatal
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.

13 secondary outcomes

Sustained remission rates of perinatal depression
Time frame: 3 months and 6 months postnatal
Change in severity of perinatal depressive symptoms
Time frame: 3 months and 6 months postnatal
Change in severity of perinatal anxiety symptoms
Time frame: 3 months and 6 months postnatal
Change in maternal Quality of Life
Time frame: 3 months and 6 months postnatal
Change in disability using the World Health Organization Disability Assessment Schedule 2.0
Time frame: 3 months and 6 months postnatal
Service use and costs
Time frame: Pregnancy through to 6 months postnatal
Infant nutrition/breastfeeding
Time frame: 3 months and 6 months postnatal
Family planning practices
Time frame: 3 months and 6 months postnatal
Infant Immunization Status
Time frame: 3 months and 6 months postnatal
Maternal Social support
Time frame: 3 months and 6 months postnatal
Parental time spent in play with the infant
Time frame: 3 months and 6 months postnatal
Diarrheal episodes among infants
Time frame: 3 months and 6 months postnatal
Acute upper respiratory tract infections among infants
Time frame: 3 months and 6 months postnatal

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
Background: PubMed 18790313Rahman 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.
Background: PubMed 30686386Sikander 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.
Background: PubMed 30686385Fuhr 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.
Background: PubMed 31157115Rahman 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.
Background: PubMed 32828167Maselko 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.
Background: PubMed 32090783Vanobberghen 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.
Derived from this study: PubMed 40200057Rahman A, Malik A, Nazir H, Zaidi A, Nisar A, Waqas A, Atif N, Gibbs NK, Luo Y, Sikander S, Wang D. Technology-assisted cognitive-behavioral therapy for perinatal depression delivered by lived-experience peers: a cluster-randomized noninferiority trial. Nat Med. 2025 Jul;31(7):2196-2203. doi: 10.1038/s41591-025-03655-1. Epub 2025 Apr 8.
Derived from this study: PubMed 37626428Rahman A, Malik A, Atif N, Nazir H, Zaidi A, Nisar A, Waqas A, Sharif M, Chen T, Wang D, Sikander S. 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. 2023 Aug 25;24(1):555. doi: 10.1186/s13063-023-07581-w.
Individual participant dataSharing planned: No. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Remission rates of perinatal depression (time frame: 3 months postnatal). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05353491, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.