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Evaluation of a preventive intervention for postnatal depression in high-risk populations in Pakistan and Türkiye

Randomised evaluation of a preventive intervention for postnatal depression in high-risk populations in Pakistan and Türkiye: PREVENT-PND

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12764230
Enrollment
664
Registered
2024-08-29
Start date
2024-05-30
Completion date
Unknown
Last updated
2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perinatal depression Mental and Behavioural Disorders

Interventions

The intervention is based on the Thinking Healthy Programme (THP), an evidence-based intervention that employs cognitive behavior therapy strategies to achieve three main goals: a) To identify and mod
b) behavioral activation – adopting behaviors, such as self-care, attention to diet, and positive interactions with the infant, and practising these between sessions
c) problem-solving to overcome barriers to practising such strategies. The adapted THP brief group version (THP-BGV) employs similar strategies adapted for prevention rather than treatment of perinata
2) psychoeducation and problem-management skills
3) focusing on one’s personal health and well-being
4) establishing the mother-infant bond, and 5) reactivating relationships with others and closing the therapy. The study aims to schedule the five intervention group sessions weekly
however, it is understood that unforeseen circumstances may arise. Therefore, a flexibility window of up to two weeks will be provided after the target date for scheduling a group session. If a group

Sponsors

University of Liverpool
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 120 Years

Inclusion criteria

Inclusion criteria: 1. Pregnant women aged 18 years and over 2. Within the 2nd to early 3rd trimester of pregnancy (13 to 34 weeks pregnancy) 3. Having current mild depressive symptoms with a score between 5 to 9 on PHQ-9 and/or having significant symptoms of anxiety with a score of or above scores on GAD-7 4. Intending to reside in the study area for the entire duration of the follow-up (approx. one year) 5. In Türkiye, ownership, and ability to use a smartphone

Exclusion criteria

Exclusion criteria: 1. Women requiring immediate inpatient care for any reason (medical or psychiatric) 2. Women who are currently receiving any form of counselling or mental health care or report suicidal ideation 3. Women who do not speak and/or comprehend local, Urdu languages (Urdu, Potohari or Punjabi in Pakistan and Turkish language for Türkiye)

Design outcomes

Primary

MeasureTime frame
Presence of postnatal depressive symptoms measured using the 9-item Personal Health Questionnaire (PHQ-9) after 6-8 weeks of giving birth

Secondary

MeasureTime frame
Maternal Secondary Outcomes: 1. Perinatal anxiety remission rates and symptom severity: Measured using the Generalized Anxiety Disorder 7-item (GAD-7) scale at baseline, 6-8 weeks postnatal, and 6 months postnatal. 2. Maternal disability: Measured using the World Health Organization Disability Assessment Schedule (WHO-DAS), with disability defined by the total mean scores of this measure at baseline and 6 months postnatal. 3. Maternal quality of life: Measured using the EuroQol 5-Dimension (EQ-5D) questionnaire, with quality of life defined by the total mean scores of the EQ-5D at baseline, 6-8 weeks, and 6 months postnatal. Infant-related Secondary Outcomes: 1. Exclusive breastfeeding: Measured using a 24-hour maternal recall and defined by the World Health Organization's (WHO) definition of exclusive breastfeeding at 6-8 weeks and 6 months postnatal. 2. Immunization: Measured using data collected from the vaccination cards provided to all parents up to the age of 12 weeks postnatal. 3. Parental time spent playing with the infant: Measured using the Client Services Receipt Inventory (CSRI) at 6-8 weeks and 6 months postnatal. Mediational Analyses (Exploring Mechanisms): 1. Behavioural activation levels: Measured using the PREMIUM Abbreviated Activation Scale (PAAS) at baseline, 6-8 weeks, and 6 months postnatal. 2. Perceived social support: Measured using the Multidimensional Scale of Perceived Social Support (MSPSS) at baseline, 6-8 weeks, and 6 months postnatal. 3. Problem-solving skills: Measured using the Problem-Solving Confidence subscale of the Problem-Solving Inventory at baseline, 6-8 weeks, and 6 months postnatal. 4. Cognitive restructuring skills: Measured using the Cognitive Restructuring subscale of the Frequency of Actions and Thoughts (FATS) scale at baseline, 6-8 weeks, and 6 months postnatal. 5. Maternal attachment: Measured using the Maternal Postnatal Attachment Scale (M-PAS) at 6-8 weeks postnatal. 6. Maternal self-efficacy: Measured using the

Countries

Pakistan, Türkiye

Contacts

Public ContactAtif Rahman
atifr@liverpool.ac.uk+44(0)151 794 6938

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: May 16, 2026