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

Primary Purpose

Postnatal Depression

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Culturally Adapted Manual Assisted Therapy (CMAP-SI)
Sponsored by
Pakistan Institute of Living and Learning
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Postnatal Depression focused on measuring Postnatal Depression, Suicidal Ideation, LMICs, CMAP

Eligibility Criteria

16 Years - 44 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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) as a score <6 (i.e., a score of <6 mean that a patient is not suicidal; see Husain et al., 2014 for further information) and Not requiring in-patient psychiatric treatment. Exclusion Criteria: We will exclude mothers with any physical or psychiatric condition severe enough to prevent study participation.

Sites / Locations

  • Benazir Bhutto HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Culturally Adapted Manual Assisted Therapy (CMAP-SI)

Treatment as Usual (TAU)

Arm Description

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

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.

Outcomes

Primary Outcome Measures

System Usability Scale
Usability of the interventions will be measured with the System Usability Scale (SUS). The SUS is composed of 10 statements that are scored on a 5-point scale of extent of agreement (score 0 to 100). The reliability is good (α=0.91) (Bangor et al., 2008). Interventions with scores of 70 and above are accepted as highly usable (Bangor et al., 2008) and scores between 50 and 70 indicate acceptable usability of an intervention. Interventions with scores 50 and below are subject to concerns about their usability by the target population.

Secondary Outcome Measures

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.
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).
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).
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).
Life Events Checklist (Husain et al., 2000)
Life events and difficulties will be assessed using a specially designed questionnaire based on our previous work in Pakistan. The domains that accounted for most of the life events and difficulties were included and rated categorically as present or not in the previous 12 months. This questionnaire has been used in a study of postnatal depression in rural Pakistan (Rahman, Iqbal, & Harrington, 2003) and for perinatal depression in Urban Pakistan (Husain et al., 2011).
Oslo- 3 Social Support Scale (O3SSS) (Dalgard, 2009)
Oslo- 3 Social Support Scale will be used to assess the relationship with friends, family and neighbours. Each item is scored on a 5-point rating scale, and the total score ranges from 3 to 15, with high scores indicating a greater level of support. Its structure and reliability have not been well-documented despite its widespread use. The instrument has been validated in Urdu (Husain et al., 2012) and the Cronbach's alpha for the Urdu translation of the instrument was 0.46 (Husain et al., 2021).
Euro Quol (EQ-5D) (Rabin & Charro, 2001)
Euro Quol -5D will be used to measure the health-related quality of life. EQ-5D is an instrument measuring health quality of life and has 5 items: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression (Rabin & Charro, 2001). Each item is required to be rated as 1 (no problem), 2 (some problem) or 3 (extreme problem). The current health state is also rated on a scale ranging from 0 (worst imaginable state) to 100 (best imaginable state). The instrument has been validated in Urdu (Husain et al., 2017).

Full Information

First Posted
May 1, 2023
Last Updated
August 25, 2023
Sponsor
Pakistan Institute of Living and Learning
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1. Study Identification

Unique Protocol Identification Number
NCT05852314
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 10, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pakistan Institute of Living and Learning

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postnatal Depression
Keywords
Postnatal Depression, Suicidal Ideation, LMICs, CMAP

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Culturally Adapted Manual Assisted Therapy (CMAP-SI)
Arm Type
Experimental
Arm Description
Participants in this arm will be offered the CMAP-SI intervention. The intervention will be delivered by trained researchers.
Arm Title
Treatment as Usual (TAU)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Culturally Adapted Manual Assisted Therapy (CMAP-SI)
Intervention Description
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.
Primary Outcome Measure Information:
Title
System Usability Scale
Description
Usability of the interventions will be measured with the System Usability Scale (SUS). The SUS is composed of 10 statements that are scored on a 5-point scale of extent of agreement (score 0 to 100). The reliability is good (α=0.91) (Bangor et al., 2008). Interventions with scores of 70 and above are accepted as highly usable (Bangor et al., 2008) and scores between 50 and 70 indicate acceptable usability of an intervention. Interventions with scores 50 and below are subject to concerns about their usability by the target population.
Time Frame
At 3 months after baseline
Secondary Outcome Measure Information:
Title
Beck Scale for Suicidal Ideation (BSS) (Beck et al., 1988)
Description
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
Title
Suicide Attempt and Self-Harm (SASH) (Eylem, 2011)
Description
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
Title
Edinburgh postnatal depression scale (EPDS) (Cox et al., 1987)
Description
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
Title
Beck Depression Inventory (BDI) (Beck et al., 1961)
Description
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
Title
Life Events Checklist (Husain et al., 2000)
Description
Life events and difficulties will be assessed using a specially designed questionnaire based on our previous work in Pakistan. The domains that accounted for most of the life events and difficulties were included and rated categorically as present or not in the previous 12 months. This questionnaire has been used in a study of postnatal depression in rural Pakistan (Rahman, Iqbal, & Harrington, 2003) and for perinatal depression in Urban Pakistan (Husain et al., 2011).
Time Frame
Baseline and 3 months
Title
Oslo- 3 Social Support Scale (O3SSS) (Dalgard, 2009)
Description
Oslo- 3 Social Support Scale will be used to assess the relationship with friends, family and neighbours. Each item is scored on a 5-point rating scale, and the total score ranges from 3 to 15, with high scores indicating a greater level of support. Its structure and reliability have not been well-documented despite its widespread use. The instrument has been validated in Urdu (Husain et al., 2012) and the Cronbach's alpha for the Urdu translation of the instrument was 0.46 (Husain et al., 2021).
Time Frame
Baseline and 3 months
Title
Euro Quol (EQ-5D) (Rabin & Charro, 2001)
Description
Euro Quol -5D will be used to measure the health-related quality of life. EQ-5D is an instrument measuring health quality of life and has 5 items: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression (Rabin & Charro, 2001). Each item is required to be rated as 1 (no problem), 2 (some problem) or 3 (extreme problem). The current health state is also rated on a scale ranging from 0 (worst imaginable state) to 100 (best imaginable state). The instrument has been validated in Urdu (Husain et al., 2017).
Time Frame
Baseline and 3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) as a score <6 (i.e., a score of <6 mean that a patient is not suicidal; see Husain et al., 2014 for further information) and Not requiring in-patient psychiatric treatment. Exclusion Criteria: We will exclude mothers with any physical or psychiatric condition severe enough to prevent study participation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tayyaba Kiran, PhD.
Phone
021-35871845
Email
tayyaba.kiran@pill.org.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Rabia Sattar, PhD. Cont.
Phone
04237881614
Email
rabia.sattar@pill.org.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nasim Chaudhry, MD
Organizational Affiliation
Pakistan Institute of Living and Learning
Official's Role
Principal Investigator
Facility Information:
Facility Name
Benazir Bhutto Hospital
City
Rawalpindi
State/Province
Punjab
Country
Pakistan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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

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