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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age16-44
SponsorPakistan Institute of Living and Learning

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

16 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)

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Culturally Adapted Manual Assisted Therapy (CMAP-SI)Experimental treatment 1 intervention
Group B: Treatment as Usual (TAU)No intervention 0 interventions

Trial outcomes

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

Time frame
At 3 months after baseline

Secondary outcomes

1

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

Beck Scale for Suicidal Ideation will be used to measure the reduction in frequency and intensity of suicidal thoughts at baseline and at 3 months. The BSS is a 21-item measure assessing the severity of the suicidal ideation (Beck et al., 1988). Each item is scored from 0 to 2. The total score is obtained by adding the first 19 items and ranges from 0 to 38. High score represents high suicidal ideation. The BSS has good psychometric properties in English (Beck et al., 1988) This scale has been previously used in Pakistan (Husain et al., 2014) and the reported Cronbach's alpha for the Urdu translation of the BSI were 0.75 and 0.89 (Husain et al., 2014) respectively.

Time frame
Baseline and 3 months
2

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

Suicide Attempt and Self-Harm consists of four questions measuring the previous suicide attempt and the presence of self-harm during last 6 weeks with a response on either 'yes, with a frequency of suicide attempt or self harm' or 'no'. SASH questions were taken from the original Self-Harm Questionnaire (Eylem, 2010). The original scale showed good psychometric properties (Eylem, 2010; Ougrin \& Boege, 2013).

Time frame
Baseline and 3 months
3

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

Edinburgh postnatal depression scale will be used to screen depression in mothers with children aged 0-30 months. The maximum score of EPDS is 30, while score 10 or above shows possible depression. The EPDS has been translated into Urdu and validated in Pakistan (Husain et al., 2013).

Time frame
Baseline and 3 months
4

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

Beck Depression Inventory will be used to measure symptoms of depression. BDI comprised of 21 items. Each item is scored from 0 to 3. The severity ranges from minimal depressed (score lower than 13) to severely depressed (scores between 29 and 63). It is a reliable and valid measure for assessing depression. The Cronbach's alpha for the Urdu translation of the instrument was 0.96 (Husain et al., 2014).

Time frame
Baseline and 3 months

Other outcomes

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