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

NCT05852314 | Recruiting DMC

• 1 other identifier: CMAP- PNSI
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Postnatal Depression

Keywords

Postnatal Depression; Suicidal Ideation; LMICs; CMAP

Outcome Measures

Primary Outcomes (1)

• Feasibility and Acceptability

  The feasibility is defined as engagement with the intervention, its usability in daily life, as well as its potential for delivering a full trial in future. The feasibility of the study procedures will be assessed through monitoring recruitment and retention rates. Acceptability operationalised as the extent to which the participants receiving the intervention considered it to be appropriate, will be assessed through each participant's attendance rates in the intervention session. Additionally, the feasibility and acceptability will also be measured through qualitative interviews at post intervention

  At 3 months after baseline

Secondary Outcomes (7)

• Beck Scale for Suicidal Ideation (BSS) (Beck et al., 1988)

  Baseline and 3 months

• Suicide Attempt and Self-Harm (SASH) (Eylem, 2011)

  Baseline and 3 months

• Edinburgh postnatal depression scale (EPDS) (Cox et al., 1987)

  Baseline and 3 months

• Beck Depression Inventory (BDI) (Beck et al., 1961)

  Baseline and 3 months

• Life Events Checklist (Husain et al., 2000)

  Baseline and 3 months

Study Arms (2)

Culturally Adapted Manual Assisted Therapy (CMAP-SI)

EXPERIMENTAL

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

Behavioral: Culturally Adapted Manual Assisted Therapy (CMAP-SI)

Treatment as Usual (TAU)

NO INTERVENTION

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.

Interventions

Culturally Adapted Manual Assisted Therapy (CMAP-SI) 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.

Culturally Adapted Manual Assisted Therapy (CMAP-SI)

Eligibility Criteria

• Age: 16 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Pakistan Institute of Living and Learning: lead

Study Sites (1)

Benazir Bhutto Hospital

Rawalpindi, Punjab Province, Pakistan

RECRUITING

MeSH Terms

Conditions

Depression, Postpartum; Suicidal Ideation

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Nasim Chaudhry, MD

  Pakistan Institute of Living and Learning

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tayyaba Kiran, PhD.

CONTACT

021-35871845; tayyaba.kiran@pill.org.pk

Rabia Sattar, PhD. Cont.

CONTACT

04237881614; rabia.sattar@pill.org.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2023
• First Posted: May 10, 2023
• Study Start: July 10, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)