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. 2023 Oct 24;2023(10):CD014722. doi: 10.1002/14651858.CD014722.pub2

NCT04819711.

Study name Addressing perinatal depression in deprived areas of Istanbul, Turkey
Methods Study design: RCT
Country: Turkey
Participants Pregnant women between 12‐30 weeks' gestation
Inclusion criteria: 
a. pregnant women over 18 years between 12‐30 weeks' gestation;
b. access to the internet:
c. intend to attend all 5 sessions of the antenatal classes.
Exclusion criteria:
a. currently receiving any form of counselling or mental health care;
b. report suicidal ideation (women);
c. if miscarriage, stillbirth or preterm birth, will also be excluded from the follow‐up assessment.
Stated purpose: to pilot this adapted on‐line group intervention in selected hospitals' pregnancy schools
Interventions Intervention:
Thinking Healthy Programme
The Thinking Healthy Programme (THP) is an evidence‐based intervention that is based on principles of cognitive behavioural therapy. It includes strategies that incorporate behavioural activation, active listening, collaboration with the family, guided discovery, and homework. The adapted THP consists of 5 integrated sessions. Session 1 introduces the programme and focuses on engagement of participants, introduction of THP, and breathing exercises. Session 2 focuses on psychoeducation and problem‐solving. Session 3 focuses on the mother's well‐being and introduces activities such as physical exercises, good sleep practices and ensuring a balanced diet. Session 4 focuses on the mother's relationship with the unborn baby. Session 5 focuses on activating social support from family, friends and peers and provides closure of therapy.
Control:
Usual care (antenatal pregnancy school classes: 5 sessions of the routine group antenatal pregnancy school classes. The class provides education about pregnancy, birth and newborn care and offers support to women. The women will also be able to access all usual care and support offered by the participating hospitals)
Outcomes Participants'outcomes of interest for this review
  1. Mental health symptoms/depression – Edinburgh Postnatal Depression Scale (EPDS)

  2. Mental health symptoms/anxiety – Generalized Anxiety Disorder‐7 (GAD‐7)

  3. Social outcomes (perceived social support) – Multidimensional Scale of Perceived Social Support (MSPSS)

  4. Psychological functioning and impairment (coping skills) – Coping Orientation to Problems Experienced Inventory (Brief‐COPE)

  5. Psychological functioning and impairment – World Health Organisation Disability Assessment Schedule (WHODAS 2.0)


Economic outcomes
Nil
Time points: baseline, post‐intervention (4‐6 weeks after intervention)
Starting date April 2021
Contact information Perran Boran, drperran@yahoo.com
Notes Source of funding: not specified (only list of sponsors and collaborators)
Prospective trial registration number: NCT04819711