Addressing Perinatal Depression in Deprived Areas of Istanbul, Turkey

NCT04819711 | Completed

• 1 other identifier: MR/T038616/1
• Study Type: interventional
• Target: 88
• Locations: 2 countries
• Sites: 2

Brief Summary

In Turkey, the prevalence rate of perinatal depression has been estimated between 20%-40%, reflecting the global average of 25%. Untreated perinatal depression is of concern not only because of its effect on maternal health but also from the effect that impaired maternal role fulfilment has on the mother-infant bonding and child care and the long-term impact on the infant's physical and cognitive development. Thinking Healthy Programme (THP) is an evidence-based intervention incorporated into the World Health Organization's flagship Mental Health Gap Action Programme, tailored to the perinatal period that has been shown to be effective for depressed or stressed mothers. Turkey prioritize antenatal care, and this provides an opportunity to integrate mental health care into an existing antenatal care programme. Public hospitals operate 'antenatal pregnancy schools' where women are invited to attend 5 weekly group sessions that incorporate education about pregnancy and newborn care. We have developed an on-line group version of the Thinking Healthy Programme which has been designed to be integrated into the routine on-line antenatal pregnancy classes. The intervention has been designed so it is suitable for all women (universal) rather than depressed mothers only (targeted). The aim of this study is to pilot this adapted on-line group intervention in selected hospitals' pregnancy schools. The study will be a two-arm pilot individual randomised controlled trial comparing the Thinking Healthy group intervention integrated into antenatal pregnancy school classes with antenatal pregnancy school classes alone. Our sample size of 60 pregnant women (that is 30 participants in each arm of the pilot trial), who are over 18 years old, between 12-30 weeks' gestation, and intend to attend all 5 sessions of the online antenatal classes. Participants in both arms will be assessed for depression and anxiety symptoms, levels of disability, quality of sleep, perceived social support, coping skills, and relationship with partner. All one hundred and twenty women will get a detailed assessment initially and 4-6 weeks after the intervention. Some of the study participants and antenatal nurses delivering these sessions will be approached for in-depth qualitative interviews to explore the acceptability, feasibility and perceptions of the study participants' receiving the intervention sessions.

Conditions

Perinatal Depression

Keywords

depression; anxiety; disability; sleep; social support

Outcome Measures

Primary Outcomes (1)

• Change in Depression

  Edinburgh Postnatal Depression Scale. This is a 10-item self-administered scale, each item is rated on a four-point scale, giving maximum scores of 30. A score of 13 or more is considered to be a significant case of postnatal depression, while scores of 10 to 12 represent borderline. It is developed for detection of symptoms of psychosocial distress during pregnancy and in the postnatal period.

  Baseline and at 4-6 weeks after the intervention

Secondary Outcomes (7)

• Change in Disability

  Baseline and at 4-6 weeks after the intervention

• Change in Depression

  Baseline and at 4-6 weeks after the intervention

• Change in Anxiety

  Baseline and 4-6 weeks after the intervention

• Change in Sleep quality

  Baseline and 4-6 weeks after the intervention

• Change in Perceived social support

  Baseline and 4-6 weeks after the intervention

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Thinking Healthy group intervention integrated into antenatal pregnancy school classes

Behavioral: Thinking Healthy Programme

Control

NO INTERVENTION

Participants randomized to the control arm will not be offered the THP intervention but will attend the 5 sessions of the routine group antenatal pregnancy school classes. The class provides education about pregnancy, birth and new-born care and offers support to women. The women will also be able to access all usual care and support offered by the participating hospitals

Interventions

Thinking Healthy Programme BEHAVIORAL

The Thinking Healthy Programme (THP) is an evidence-based intervention that is based on principles of cognitive behavioral therapy. It includes strategies that incorporate behavioral 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.

Intervention

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: pregnant women between 12-30 weeks' gestation
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• pregnant women over 18 years between 12-30 weeks' gestation have access to internet, intend to attend all 5 sessions of the antenatal classes

You may not qualify if:

• currently receiving any form of counselling or mental health care, who report suicidal ideation women who have a miscarriage, stillbirth or preterm birth will also be excluded from the follow-up assessment

Sponsors & Collaborators

• Perran Boran: lead
• Medical Research Council: collaborator

Study Sites (2)

Marmara University School of Medicine

Istanbul, Turkey (Türkiye)

Location

University of Liverpool

Manchester, United Kingdom

Location

Related Publications (1)

• Boran P, Donmez M, Baris E, Us MC, Altas ZM, Nisar A, Atif N, Sikander S, Hidiroglu S, Save D, Rahman A. Delivering the Thinking Healthy Programme as a universal group intervention integrated into routine antenatal care: a randomized-controlled pilot study. BMC Psychiatry. 2023 Jan 6;23(1):14. doi: 10.1186/s12888-022-04499-6.

  PMID: 36604685 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The main outcomes will be recorded by outcome assessors blinded to treatment allocation. It will not be possible to blind antenatal nurses delivering the intervention in participating centres or the participants themselves to intervention allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Pediatrics

Model Details: two-arm pilot individual randomised controlled trial

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: March 29, 2021
• Study Start: April 5, 2021
• Primary Completion: October 20, 2021
• Study Completion: November 11, 2021
• Last Updated: August 26, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: when data is ready for analysis
• Access Criteria: Any data sharing request will be made to investigators through a pre-defined data requisition form. This form will contain information about the applicant, institution, purpose of data request, study objectives, ethical clearance of the study, etc. Once a request has been made the data governance body will discuss if that request was appropriate and meets the criteria set by the participating centres; data will be released following signing of the data sharing agreement. The data will be stored on the Marmara University and UoL servers and not be deposited in any 'community' database.

Locations

GB (1); TU (1)