Clinical trial NCT05852314: A Problem-Solving Intervention for Women With Suicidal Ideation During Postnatal Period in Pakistan
Official title: Culturally Adapted Manual-Assisted Problem-Solving Intervention for Women With Suicidal Ideation in Postnatal Period in Pakistan: A Feasibility Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postnatal Depression
Keywords: Postnatal Depression
Suicidal Ideation
LMICs
CMAP
Lead sponsor: Pakistan Institute of Living and Learning
Sponsor class: OTHER
First posted: 2023-05-10
Enrollment: 90
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 44
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study is to determine the feasibility and acceptability of culturally adapted CMAP for suicidal Ideation for women in postnatal period.

Objectives

1. To adapt existing CMAP Intervention for suicidal ideation (CMAP-SI) in postnatal period.
2. To investigate whether CMAP-SI is feasible and acceptable among women presenting suicidal Ideations in postnatal period; and
3. To test whether there is an indication for the effects of the CMAP in reducing suicidal thoughts among women in postnatal period.
4. To explore participants experiences with CMAP-SI Intervention.

Detailed description: Suicide is a major public health concern globally, affecting not only the individuals but also family members and society through increased resource costs and productivity loss. Although suicides and suicide attempts occur at a lower rate during pregnancy and the postpartum period than in general population, the prevalence of suicidal thoughts during these periods ranges from 5-14% worldwide and this may result in suicide attempts and completions. There is a growing evidence suggesting that suicidal thoughts and behaviour among women in postnatal period in Low-and Middle-Income Countries (LMICs) are comparable to postnatal women in high resource settings. For instance, in observational studies based on hospital samples of women in postnatal period, 11% women had suicidal behaviour (i.e., thoughts and attempts) in Pakistan, 14% in Ethiopia and 13.6% in Nepal. The causes of these high prevalence rates point to the underlying maternal health issues such as antenatal depression and common mental disorders such as anxiety and depression. Evidence based interventions exists in prevention, care and treatment of suicidal thoughts such as Cognitive Behavioural Therapy (CBT). To deliver a CBT based intervention in Pakistani context, Husain and colleagues tailored a treatment manual: "Life after Self-Harm" to the general population in Pakistan. This Culturally Adapted Manual Assisted Problem solving (CMAP) aims at suicide prevention by reducing the probability of self-harm. Pakistan being a low resource setting faces a huge challenge to provide health care to its population. Therefore, it is important to screen women in postnatal period for risk for suicidal thoughts and behaviour, as well as, the maternal health problems. It is equally important to deliver culturally sensitive interventions which are addressing the psycho-social context wherein suicidal behaviour occurs. Thus, the main aim of this study is to determine the feasibility and acceptability of culturally adapted CMAP for suicidal Ideation for women in postnatal period.

Eligibility criteria: Inclusion Criteria:

1. 16 to 44-year-old mothers with children 0 - 30 months old
2. Residents of the trial site catchments area
3. Able to provide informed consent
4. Presenting with suicidal ideation as measured by the Beck Suicidal Ideation Scale (BSSI) (must score 1 or 2 on item 4 and 5)
5. Not requiring in-patient psychiatric treatment.

Exclusion Criteria:

We will exclude mothers with any physical or psychiatric condition severe enough to prevent study participation.

Primary outcomes:
measure: Feasibility and Acceptability
timeFrame: At 3 months after baseline
Secondary outcomes:
measure: Beck Scale for Suicidal Ideation (BSS) (Beck et al., 1988)
timeFrame: Baseline and 3 months
measure: Suicide Attempt and Self-Harm (SASH) (Eylem, 2011)
timeFrame: Baseline and 3 months
measure: Edinburgh postnatal depression scale (EPDS) (Cox et al., 1987)
timeFrame: Baseline and 3 months
measure: Beck Depression Inventory (BDI) (Beck et al., 1961)
timeFrame: Baseline and 3 months
measure: Life Events Checklist (Husain et al., 2000)
timeFrame: Baseline and 3 months
measure: Oslo- 3 Social Support Scale (O3SSS) (Dalgard, 2009)
timeFrame: Baseline and 3 months
measure: Euro Quol (EQ-5D) (Rabin & Charro, 2001)
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Benazir Bhutto Hospital
state: Punjab
Study officials:
affiliation: Pakistan Institute of Living and Learning
name: Nasim Chaudhry, MD
role: PRINCIPAL_INVESTIGATOR
References: