Post Partum DepressionPADNCT04663243
Effectiveness of Thinking Healthy Program for Prevention of Antenatal Depression
A study testing Thinking healthy Program sessions designed for antenatal period in people with Post Partum Depression, run by University of the Punjab at 1 site in Pakistan.
Trial summary
The trial is to evaluate the effect of an evidence-informed, depression focused early prenatal prevention intervention at six weeks' postpartum. Secondary objective is to explore demographical and psychosocial factors responsible for development of prenatal and postpartum depression. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Partum Depression
- What is being tested?
- Thinking healthy Program sessions designed for antenatal period
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 sitePakistan
- Study dates
- 3 Jul 2020to 29 Apr 2021
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women with 24-26 weeks pregnancy.
- Women assessed as having mild to moderate levels of depression [i.e., score ≥10 on Personal Health Care Questionnaire (PHQ-9)] tool validated in Pakistan for the use of non-specialist.
Who cannot join
- Women having depression severe depression [i.e., score ≥20 on Personal Health Care Questionnaire (PHQ-9)]
- Women will be diagnosed serious medical condition requiring inpatient or outpatient treatment,
- Pregnancy-related illness (except for common conditions, such as anaemia)
- Any physical or learning disability or other form of psychosis
- Women younger than 18 and greater than 45 years will also be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Thinking Healthy Program for Prevention of Antenatal Depression to Improve Maternal Health, Pakistan
The trial is to evaluate the effect of an evidence-informed, depression focused early prenatal prevention intervention at six weeks' postpartum. Secondary objective is to explore demographical and psychosocial factors responsible for development of prenatal and postpartum depression. Investigator will also examine the potential mediators of depression and the effect of intervention on depression and its related factors i.e. marital relationship, social support, empowerment and history of intimate partner violence. Pregnant women coming for their antenatal visits to the Sheikh Zayed Hospital (SZH), a public facility in Lahore, Pakistan, will be screened for eligibility. Eligible women will be 24-26 weeks pregnancy who will be assessed as having mild to moderate levels of depression [i.e., score ≥10 on Personal Health Care Questionnaire (PHQ-9)] validated in Pakistan for the use of non-specialist.
Read the detailed description
The present study aims to evaluate the effectiveness of evidence informed, depression focused early prenatal prevention intervention in pregnant women at six weeks' postpartum. Investigator hypothesize that women with subclinical to clinical levels of prenatal depression to the intervention will result in fewer cases of depression (mild to moderate) at six weeks' postpartum. The primary objective of the trial is to evaluate the effect of an evidence-informed, depression focused early prenatal prevention intervention at six weeks' postpartum. Secondary objective is to explore demographical and psychosocial factors responsible for development of prenatal and postpartum depression. We will also examine the potential mediators of depression and the effect of intervention on depression and its related factors i.e. marital relationship, social support, empowerment and history of intimate partner violence. Pregnant women coming for their antenatal visits to the Sheikh Zayed Hospital (SZH), a public facility in Lahore, Pakistan, will be screened for eligibility. Eligible women will be 24-26 weeks pregnancy who will be assessed as having mild to moderate levels of depression [i.e., score ≥10 on Personal Health Care Questionnaire (PHQ-9)] validated in Pakistan for the use of non-specialist.
An intervention thinking Healthy Program (THP) will be done in which Investigator will enroll up to twenty (20) pregnant women. Low line psychosocial intervention based on the principles of Cognitive Behavior Therapy (CBT), designed for non-specialist will be applied for expectant women experiencing depression during mid to late-pregnancy. It uses the core principles and strategies of the Thinking Healthy Program (THP), an evidence-based psychosocial intervention for mothers experiencing perinatal depression, including empathetic listening, thought challenging, behavior activation, family involvement, and problem management. Additionally, stress management skills such as breathing exercises are incorporated. Culturally relevant customized illustrations are used for guided discovery, behavior activation, stress management, and to convey key health messages. The intervention is a series of one-on-one sessions, complemented by take home exercises. Before and after intervention comparison will be made to find out the efficacy of intervention. The data will be collected at one site: Sheikh Zayed Hospital, a public tertiary care facility in Lahore, Pakistan. It will take six months for data collection.
- Conditions
- Post Partum Depression
- Being tested
- Thinking healthy Program sessions designed for antenatal period
- Keywords
- Antenatal depression, psychosocial factors, Thinking Healthy Program
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thinking healthy Program sessions designed for antenatal periodBehavioural
Also called Psychoeducation
Low line psychosocial intervention based on the principles of Cognitive Behavior Therapy (CBT), designed for non-specialist will be applied for expectant women experiencing depression during mid to late-pregnancy. It uses the core principles and strategies of the Thinking Healthy Program (THP). Four core sessions and two booster sessions will be applied, designed for antenatal period to prevent antenatal and post partum depression.
| Study group | Role | What they receive |
|---|---|---|
| Quasi experimental study | Experimental | Before intervention and after intervention comparison Receives: Behavioral: Thinking healthy Program sessions designed for antenatal period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of antenatal depression
Screening of patients with antenatal depression using PHQ-9 tool for calculation of percentage(%) of depressive women in pregnancy before 6 sessions of Thinking Healthy Program
Measured: Five months
Assessment of postpartum depression after 6 sessions of Thinking Healthy Program
Screening of patients with post depression using PHQ-9 tool for calculation of percentage(%) of depressive women in postpartum period
Measured: After delivery to 6 weeks (puerperium period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start3 Jul 2020
- Primary completion29 Jan 2021
- Study completion29 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Partum 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Quasi experimental study
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Punjab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Quratulain Ahsan, University of the Punjab
- Investigators
- Abid Malik, PhD, Study chair, Human Development Research Foundation, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04663243
- Sponsor's protocol ID
- THP in clinical settings
- Acronym
- PAD
- Status last verified
- Sep 2021
- First submitted
- 30 Oct 2020
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The primary objective of the trial is to evaluate the effect of an evidence-informed, depression focused early prenatal prevention intervention at six weeks' postpartum. Secondary objective is to explore demographical and psychosocial factors responsible for development of prenatal and postpartum depression. Pregnant women coming for their antenatal visits to the Sheikh Zayed Hospital (SZH), a public facility in Lahore, Pakistan, will be screened for eligibility. Eligible women will be 24-26 weeks pregnancy who will be assessed as having mild to moderate levels of depression \[i.e., score ≥10 on Personal Health Care Questionnaire (PHQ-9)\].
Publications
Ahsan Q, Saleem J, Ishaq M, Zakar R, Abbas S, Shahzad R, Khan SM, Fischer F. Determinant factors and coping strategies for depression among pregnant women: an intervention-based qualitative study in Lahore, Pakistan. BMC Psychiatry. 2024 Nov 19;24(1):829. doi: 10.1186/s12888-024-06280-3.
PubMed 39563299
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Thinking Healthy Program for Prevention of Antenatal Depression to Improve Maternal Health, Pakistan
- ClinicalTrials.gov ID
- NCT04663243
- Acronym / sponsor ID
- PAD / THP in clinical settings
- Conditions
- Post Partum Depression
- Keywords
- Antenatal depression, psychosocial factors, Thinking Healthy Program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of the PunjabUniversity, hospital or other
- Study start
- 3 Jul 2020 (actual)
- Primary completion
- 29 Jan 2021 (actual)
- Study completion
- 29 Apr 2021 (actual)
- First posted
- 10 Dec 2020 (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.
The trial is to evaluate the effect of an evidence-informed, depression focused early prenatal prevention intervention at six weeks' postpartum. Secondary objective is to explore demographical and psychosocial factors responsible for development of prenatal and postpartum depression. Investigator will also examine the potential mediators of depression and the effect of intervention on depression and its related factors i.e. marital relationship, social support, empowerment and history of intimate partner violence. Pregnant women coming for their antenatal visits to the Sheikh Zayed Hospital (SZH), a public facility in Lahore, Pakistan, will be screened for eligibility. Eligible women will be 24-26 weeks pregnancy who will be assessed as having mild to moderate levels of depression [i.e., score ≥10 on Personal Health Care Questionnaire (PHQ-9)] validated in Pakistan for the use of non-specialist.
Detailed description
The present study aims to evaluate the effectiveness of evidence informed, depression focused early prenatal prevention intervention in pregnant women at six weeks' postpartum. Investigator hypothesize that women with subclinical to clinical levels of prenatal depression to the intervention will result in fewer cases of depression (mild to moderate) at six weeks' postpartum. The primary objective of the trial is to evaluate the effect of an evidence-informed, depression focused early prenatal prevention intervention at six weeks' postpartum. Secondary objective is to explore demographical and psychosocial factors responsible for development of prenatal and postpartum depression. We will also examine the potential mediators of depression and the effect of intervention on depression and its related factors i.e. marital relationship, social support, empowerment and history of intimate partner violence. Pregnant women coming for their antenatal visits to the Sheikh Zayed Hospital (SZH), a public facility in Lahore, Pakistan, will be screened for eligibility. Eligible women will be 24-26 weeks pregnancy who will be assessed as having mild to moderate levels of depression [i.e., score ≥10 on Personal Health Care Questionnaire (PHQ-9)] validated in Pakistan for the use of non-specialist.
An intervention thinking Healthy Program (THP) will be done in which Investigator will enroll up to twenty (20) pregnant women. Low line psychosocial intervention based on the principles of Cognitive Behavior Therapy (CBT), designed for non-specialist will be applied for expectant women experiencing depression during mid to late-pregnancy. It uses the core principles and strategies of the Thinking Healthy Program (THP), an evidence-based psychosocial intervention for mothers experiencing perinatal depression, including empathetic listening, thought challenging, behavior activation, family involvement, and problem management. Additionally, stress management skills such as breathing exercises are incorporated. Culturally relevant customized illustrations are used for guided discovery, behavior activation, stress management, and to convey key health messages. The intervention is a series of one-on-one sessions, complemented by take home exercises. Before and after intervention comparison will be made to find out the efficacy of intervention. The data will be collected at one site: Sheikh Zayed Hospital, a public tertiary care facility in Lahore, Pakistan. It will take six months for data collection.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Quasi experimental study
| Arm | Type | Receives |
|---|---|---|
| Quasi experimental study | Experimental | Behavioral: Thinking healthy Program sessions designed for antenatal periodBefore intervention and after intervention comparison |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women with 24-26 weeks pregnancy.
- Women assessed as having mild to moderate levels of depression [i.e., score ≥10 on Personal Health Care Questionnaire (PHQ-9)] tool validated in Pakistan for the use of non-specialist.
Key exclusion criteria (5 listed)
- Women having depression severe depression [i.e., score ≥20 on Personal Health Care Questionnaire (PHQ-9)]
- Women will be diagnosed serious medical condition requiring inpatient or outpatient treatment,
- Pregnancy-related illness (except for common conditions, such as anaemia)
- Any physical or learning disability or other form of psychosis
- Women younger than 18 and greater than 45 years will also 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 |
|---|---|---|
| Thinking healthy Program sessions designed for antenatal periodAlso: PsychoeducationLow line psychosocial intervention based on the principles of Cognitive Behavior Therapy (CBT), designed for non-specialist will be applied for expectant women experiencing depression during mid to late-pregnancy. It uses the core principles and strategies of the Thinking Healthy Program (THP). Four core sessions and two booster sessions will be applied, designed for antenatal period to prevent antenatal and post partum depression. | Behavioural | Quasi experimental study |
Primary outcome
Assessment of antenatal depression
Time frame: Five months
Screening of patients with antenatal depression using PHQ-9 tool for calculation of percentage(%) of depressive women in pregnancy before 6 sessions of Thinking Healthy Program
Assessment of postpartum depression after 6 sessions of Thinking Healthy Program
Time frame: After delivery to 6 weeks (puerperium period)
Screening of patients with post depression using PHQ-9 tool for calculation of percentage(%) of depressive women in postpartum period
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 23 Sep 2021.
- Derived from this study: PubMed 39563299Ahsan Q, Saleem J, Ishaq M, Zakar R, Abbas S, Shahzad R, Khan SM, Fischer F. Determinant factors and coping strategies for depression among pregnant women: an intervention-based qualitative study in Lahore, Pakistan. BMC Psychiatry. 2024 Nov 19;24(1):829. doi: 10.1186/s12888-024-06280-3.
- Individual participant dataSharing planned: Yes. The primary objective of the trial is to evaluate the effect of an evidence-informed, depression focused early prenatal prevention intervention at six weeks' postpartum. Secondary objective is to explore demographical and psychosocial factors responsible for development of prenatal and postpartum depression. Pregnant women coming for their antenatal visits to the Sheikh Zayed Hospital (SZH), a public facility in Lahore, Pakistan, will be screened for eligibility. Eligible women will be 24-26 weeks pregnancy who will be assessed as having mild to moderate levels of depression [i.e., score ≥10 on Personal Health Care Questionnaire (PHQ-9)].
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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.
Abid Malik, PhD study chair
Human Development Research Foundation, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thinking healthy Program sessions designed for antenatal period in people with Post Partum Depression, run by University of the Punjab at 1 site in Pakistan.
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 2 inclusion and 5 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 23 Sep 2021. 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?
Assessment of antenatal depression (time frame: Five months). The study lists 2 primary outcomes in all. 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 NCT04663243, which also lists 1 linked publication.
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 23 Sep 2021.