A Problem-Solving Intervention for Women With Suicidal Ideation During Postnatal Period in Pakistan

NCT ID: NCT05852314

Last Updated: 2024-08-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-10
• Study Completion Date: 2024-12-31

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.

Conditions

Postnatal Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Culturally Adapted Manual Assisted Therapy (CMAP-SI)

Participants in this arm will be offered the CMAP-SI intervention. The intervention will be delivered by trained researchers.

Group Type: EXPERIMENTAL

Culturally Adapted Manual Assisted Therapy (CMAP-SI)

Intervention Type: BEHAVIORAL

C-MAP has been adapted from a self-help guide called Life After Self-Harm based on the principles of CBT. It is a brief problem-solving therapy comprising have 4 sessions weekly and then 4 fortnightly and last about 50 minutes each. The manual has been translated to Urdu giving special consideration to cultural adaptation of phrases and concepts to reflect Pakistani culture. Additionally, culturally appropriate case scenarios were incorporated and a consensual view to addressing cultural factors such as gender role, family conflicts and financial difficulties was taken. The culturally adapted intervention consists of the following components: evaluation of self-harm attempt, crisis skills, problem-solving and CBT techniques to manage emotions, negative thinking, interpersonal relationships, and relapse prevention strategies. Participants will receive sessions according to adapted CMAP-SI manual.

Treatment as Usual (TAU)

Local medical, psychiatric, and primary care services provide standard routine care in Pakistan. Participants will receive an initial assessment along with TAU as ascertained by their treating primary care physician (General Practitioner, GP). As part of the safety protocol, we will obtain the contact details of the participants GP. We will also obtain the details of any treatment received by each participant. Research psychologists delivering the interventions will not be involved with the participants allocated to the TAU.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Culturally Adapted Manual Assisted Therapy (CMAP-SI)

C-MAP has been adapted from a self-help guide called Life After Self-Harm based on the principles of CBT. It is a brief problem-solving therapy comprising have 4 sessions weekly and then 4 fortnightly and last about 50 minutes each. The manual has been translated to Urdu giving special consideration to cultural adaptation of phrases and concepts to reflect Pakistani culture. Additionally, culturally appropriate case scenarios were incorporated and a consensual view to addressing cultural factors such as gender role, family conflicts and financial difficulties was taken. The culturally adapted intervention consists of the following components: evaluation of self-harm attempt, crisis skills, problem-solving and CBT techniques to manage emotions, negative thinking, interpersonal relationships, and relapse prevention strategies. Participants will receive sessions according to adapted CMAP-SI manual.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pakistan Institute of Living and Learning

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nasim Chaudhry, MD

Role: PRINCIPAL_INVESTIGATOR

Pakistan Institute of Living and Learning

Locations

Benazir Bhutto Hospital

Rawalpindi, Punjab Province, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Tayyaba Kiran, PhD.

Role: CONTACT

tayyaba.kiran@pill.org.pk

021-35871845

Rabia Sattar, PhD. Cont.

Role: CONTACT

rabia.sattar@pill.org.pk

04237881614

Other Identifiers

CMAP- PNSI

Identifier Type: -

Identifier Source: org_study_id