Addressing Perinatal Depression in Deprived Areas of Istanbul, Turkey
Condition: Perinatal Depression
MeSH terms: Asphyxia Neonatorum; Depression; Depressive Disorder
Study type: Interventional

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.
    

Detailed description: 
      Systematic reviews provide robust evidence that perinatal depression can be treated
      effectively in low to middle income countries with psychological treatments delivered by
      non-specialists. The intervention with the strongest demonstrated effect size is the Thinking
      Healthy Programme, the first psychological intervention to be incorporated into the World
      Health Organization's flagship Mental Health Gap Action Programme (mhGAP). 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. The groups
      usually consist of 8-10 mothers and are run by antenatal nurses. During the COVID19 pandemic,
      these classes have been adapted into an on-line platform. Group interventions are less
      resource-intensive per person helped than individual interventions and are possibly more
      cost-effective. 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).

      Our objectives are to conduct a pilot/feasibility study of the on-line group intervention in
      a socioeconomically deprived population in Istanbul, Turkey.

      The primary aim of this pilot study is not to test a specific hypothesis but to:

        1. test all operational elements including: the acceptability and feasibility of the
           intervention including training and supervision; the materials developed such as the
           manual, visual aids, and added activities to promote perinatal mental health and
           psychosocial well-being;

        2. test the willingness of women, and antenatal nurses to participate (recruitment rates),
           respond to questionnaires, and be followed up (attrition rates); and

        3. test the procedures for outcome measures as well as training and supervision.
           Quantitative methods will closely follow the procedures for a future definitive trial.
           The results will be used to finalise the intervention content and structure, to
           establish appropriate support systems, and to finalize all materials.

      The study will be conducted in socioeconomically deprived districts of Istanbul within the
      catchment area of the First Region of the Public Hospitals Union. Primary institution will be
      Marmara University Hospital which has an affiliation with the Ministry of Health. With the
      support of Turkish Ministry of Health, the hospital operates 'antenatal pregnancy schools'.

      Our study participants will include all consecutive pregnant women who have been offered, and
      accepted to attend, the on-line antenatal care classes during the study recruitment period.

      Because this is a feasibility/pilot trial, sample size calculations have not been conducted.
      Our sample size of 60 (that is 30 participants in each arm of the pilot trial) is based on
      the pragmatics of recruitment and the necessities for examining feasibility. The intervention
      and control arms will each consist of 3 groups per arm with 10 participants per group,
      respectively.

      The research design is a two-arm pilot individual randomised controlled trial comparing the
      Thinking Healthy group intervention integrated into antenatal health classes with antenatal
      health classes alone.The unit of randomization for the pilot trial will be individuals (i.e,
      eligible pregnant women). The generation of random allocation sequence will be carried-out by
      an independent person at the University of Liverpool UK (not involved in the enrolment of
      participants into the trial). Simple random numbers will be generated and the case will be
      assigned a Trial Number and treatment allocation (TAU or THP) which will be emailed back to
      the Local PI at Marmara in an encrypted form who will be responsible for notifying the site
      coordinator. The site coordinator will then inform both the participants and the designated
      nurses for the particular treatments to commence. To minimise the threat of selection bias
      through allocation concealment, the team recruiting/enrolling participants will be separate
      to the team opening the encrypted forms and informing participants about the treatment that
      will receive.

      The main outcomes will be recorded by outcome assessors blinded to treatment allocation.
      Participants will be asked before the interview with the assessor not to reveal anything
      about their sessions. The outcome assessors will not have information about the on-line
      groups. It will not be possible to blind therapists and antenatal nurses in participating
      centres or the participants themselves to intervention allocation.

      Intervention 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. THP was designed to be delivered by community health workers, and it was the first
      low-intensity psychological intervention to be adopted by WHO. THP has been translated and
      adapted into Turkish. For the current study, 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. It will be delivered by trained antenatal nurses who
      routinely run the antenatal classes. The routine on-line antenatal classes consist of 5
      weekly group sessions that incorporate education about pregnancy and new-born care. The
      groups usually consist of 8-10 mothers. Our adapted 'group' version of the Thinking Healthy
      Programme will be incorporated into these antenatal pregnancy classes. 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.

      Participants randomized to the control arm will not be offered the THP intervention but will
      attend the 5 sessions of the routine group antenatal class. 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.

      Assessments will take place at baseline on recruitment and one month after conclusion of the
      intervention sessions.

      Procedures for human subjects' protection in this research will follow guidelines and
      policies of the Institutional Reviews Boards (IRBs) of the sponsoring organization, the
      University of Liverpool and the implementing partner, University of Marmara, School of
      Medicine.

      The data and safety monitoring plan will involve the continuous evaluation of safety, data
      quality and data timeliness. Incoming data will be cleaned and compiled on a regular basis
      and examined for unusual or unexpected patterns. PIs and project coordinators will conduct
      continuous review of data and participant safety at monthly Project Management Group meetings
      and the discussion will be documented in minutes. The governance mechanisms will provide
      oversight to the programme. The governance and administrative activities will be based in
      Istanbul at Marmara University (School of Medicine) and will be the responsibility of the
      site investigators.

      Flow of participants through the trial will be presented as the trial flow chart. Descriptive
      statistics including socio-demographic characteristics and all baseline measures across arms
      will be tabulated to check for any baseline imbalances among the participants. Mean and
      standard deviation scores for all continuous measures shall be presented, followed by
      univariate associations between demographic variables and severity of symptoms. While the
      study is not powered to test any hypothesis, exploratory intention to treat analysis will be
      conducted to compare the two treatment groups. For baseline comparisons, t-tests will be
      conducted for continuous variables and chi-squared test for categorical ones. At follow up,
      comparisons will be made using analysis of covariance with baseline score as a co-variate.
      Any significant baseline imbalances will be treated as co-variates and adjusted for in
      analysis. All qualitative data will be analysed using framework analysis approach
    

Intervention name(s): Thinking Healthy Programme
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: two-arm pilot individual randomised controlled trial
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: depression; anxiety; disability; sleep; social support