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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quasi experimental study | Experimental | Before intervention and after intervention comparison |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thinking healthy Program sessions designed for antenatal period | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | After delivery to 6 weeks (puerperium period) |
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Inclusion Criteria:
Exclusion Criteria:
Women with 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)] tool validated in Pakistan for the use of non-specialist.
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| Name | Affiliation | Role |
|---|---|---|
| Abid Malik, PhD | Human Development Research Foundation, Pakistan | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheikh Zayed Hospital | Lahore | Punjab Province | 54000 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39563299 | Derived | 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. |
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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)].
30-3-2021
Data will be available in the form of publication, after the acceptance of paper.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 23, 2020 | Dec 9, 2020 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 13, 2020 | Dec 9, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Quasi experimental study
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| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |