Postnatal DepressionNCT05852314
A Problem-Solving Intervention for Women With Suicidal Ideation During Postnatal Period in Pakistan
A study testing Culturally Adapted Manual Assisted Therapy (CMAP-SI) in people with Postnatal Depression, run by Pakistan Institute of Living and Learning at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 44 years, women only
- Conditions the study is for
- Postnatal Depression
- What is being tested?
- Culturally Adapted Manual Assisted Therapy (CMAP-SI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Jul 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 44 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
- Not requiring in-patient psychiatric treatment.
Who cannot join
- We will exclude mothers with any physical or psychiatric condition severe enough to prevent study participation.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Benazir Bhutto Hospital
Rawalpindi, Punjab Province
About this study
Official title: Culturally Adapted Manual-Assisted Problem-Solving Intervention for Women With Suicidal Ideation in Postnatal Period in Pakistan: A Feasibility 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
- 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.
Read the 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
- Being tested
- Culturally Adapted Manual Assisted Therapy (CMAP-SI)
- Keywords
- Postnatal Depression, Suicidal Ideation, LMICs, CMAP
- Medical subject headings
- Depression, Postpartum, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally Adapted Manual Assisted Therapy (CMAP-SI)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At 3 months after baseline
Secondary outcomes (7)
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.
Measured: Baseline and 3 months
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).
Measured: Baseline and 3 months
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).
Measured: Baseline and 3 months
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).
Measured: Baseline and 3 months
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).
Measured: Baseline and 3 months
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).
Measured: Baseline and 3 months
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).
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start10 Jul 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postnatal DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Living and Learning
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nasim Chaudhry, MD, Principal investigator, Pakistan Institute of Living and Learning
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05852314
- Sponsor's protocol ID
- CMAP- PNSI
- Status last verified
- Aug 2024
- First submitted
- 1 May 2023
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally Adapted Manual-Assisted Problem-Solving Intervention for Women With Suicidal Ideation in Postnatal Period in Pakistan: A Feasibility Trial
- ClinicalTrials.gov ID
- NCT05852314
- Acronym / sponsor ID
- CMAP- PNSI
- Conditions
- Postnatal Depression
- Keywords
- Postnatal Depression, Suicidal Ideation, LMICs, CMAP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Pakistan Institute of Living and LearningUniversity, hospital or other
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 10 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Culturally Adapted Manual Assisted Therapy (CMAP-SI) | Experimental | Behavioral: 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. |
| 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. |
Who may qualify
- Ages
- 16 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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)
- Not requiring in-patient psychiatric treatment.
Key exclusion criteria (1 listed)
- We will exclude mothers with any physical or psychiatric condition severe enough to prevent study participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Culturally Adapted Manual Assisted Therapy (CMAP-SI) |
Primary outcome
Feasibility and Acceptability
Time frame: At 3 months after baseline
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
7 secondary outcomes
Beck Scale for Suicidal Ideation (BSS) (Beck et al., 1988)
Time frame: Baseline and 3 months
Suicide Attempt and Self-Harm (SASH) (Eylem, 2011)
Time frame: Baseline and 3 months
Edinburgh postnatal depression scale (EPDS) (Cox et al., 1987)
Time frame: Baseline and 3 months
Beck Depression Inventory (BDI) (Beck et al., 1961)
Time frame: Baseline and 3 months
Life Events Checklist (Husain et al., 2000)
Time frame: Baseline and 3 months
Oslo- 3 Social Support Scale (O3SSS) (Dalgard, 2009)
Time frame: Baseline and 3 months
Euro Quol (EQ-5D) (Rabin & Charro, 2001)
Time frame: Baseline and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Postnatal Depression
RecruitingPhase 3
Brexanolone Lifting Outcomes Of Moms
Depression, Postpartum, Postpartum Depression (PPD)
Recruiting
New Cognitive Treatment for Peripartum Depression
Postnatal Depression
Recruiting
Integration of Stepped Care for Perinatal Mood and Anxiety Disorders Among Women Attending MCH Clinics
Depression, Anxiety, Antenatal Depression
Not yet recruiting
Comparing Integrative Midwife-led vs. Fragmented Inpatient Postpartum Care: Impact on Satisfaction and Transition to Motherhood
Maternal Health Services, Infant, Newborn
Recruiting
Effectiveness of an Online Biopsychosocial Intervention to Improve Well-being and Mental Health During Pregnancy
Prenatal Anxiety, Prenatal Depression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nasim Chaudhry, MD principal investigator
Pakistan Institute of Living and Learning
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culturally Adapted Manual Assisted Therapy (CMAP-SI) in people with Postnatal Depression, run by Pakistan Institute of Living and Learning at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tayyaba Kiran, PhD. (021-35871845, tayyaba.kiran@pill.org.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and Acceptability (time frame: At 3 months after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024; AzTrials last refreshed its copy on 28 Oct 2026.