Perinatal DepressionNCT05393479
"Thinking Healthy Programme" for Perinatal Depression in Nepal
A study testing Thinking Healthy Programme in people with Perinatal Depression, run by Transcultural Psychosocial Organization Nepal at 1 site in Nepal.
Trial summary
As many as 1 in 3 women in Nepal suffer from perinatal depression however, they often go unidentified and untreated. Lack of knowledge limited trained human resources, and unavailability of specific maternal mental health services are some of the major barriers impeding help-seeking. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perinatal Depression
- What is being tested?
- Thinking Healthy Programme
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteNepal
- Study dates
- 15 Nov 2022to 31 Dec 2023
- 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 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women
- Should be residing in the FCHV's catchment area
- Should be between 4-7 months pregnant.
- Should have no severe physical health conditions
- Should have depressive symptoms (scores 10 or higher in PHQ-9).
Who cannot join
- Women reporting miscarriage, abortion, or still birth will be excluded from the THP intervention (but referred to the psychosocial counsellor for further care)
Trial locations and contacts
1 site in 1 country.
Nepal1 site
Transcultural Psychosocial Organization Nepal
Kathmandu, Bagmati, 44616
About this study
Official title: Feasibility, Acceptability, Appropriateness, and Preliminary Effectiveness of "Thinking Healthy Programme" for Perinatal Depression in Nepal: A Pilot Cluster Randomized Controlled Trial
As many as 1 in 3 women in Nepal suffer from perinatal depression however, they often go unidentified and untreated. Lack of knowledge limited trained human resources, and unavailability of specific maternal mental health services are some of the major barriers impeding help-seeking. To mitigate this gap, the World Health Organization recommended Thinking Healthy Programme (THP), a psychological intervention that can be delivered by non-specialists and has been proven effective for perinatal depression in a resource constrained context. The THP has already been translated and adapted to Nepali context. In this study, the investigators plan to pilot test the intervention and assess its feasibility, acceptability, appropriateness, and preliminary effectiveness when delivered by the Female Community Health Volunteers (FCHVs). The FCHVs are cadre of Nepal Government mobilized for the prevention and promotion of maternal and child health in the community level.
Read the detailed description
The Thinking Healthy Programme (THP) is a community based low-intensity psychosocial intervention tailored for perinatal depression in improving outcomes in three areas - a) mother's health, b) the mother-baby relationship, and c) the mother's relationship with others. The intervention has already been tested in other South Asian context and has been found effective in reducing depressive symptoms and promoting wellbeing even when delivered by a non-specialist with limited education. The intervention is basic and does not require prior knowledge or experience on mental health however, it is preferred that the deliverer should at least know about basics of maternal and childcare. In a resource poor country like Nepal where the investment and human resource for maternal mental health is scanty despite the high burden, the THP can be promising given its effectiveness and cost-effectiveness. The THP has already been adapted to the Nepali context.
For the pilot-testing of THP, 4 health facilities will be selected. The health facilities will be randomized to intervention and control arm (2 health facilities in each arm). A list of pregnant women from the health facility's and FCHV's catchment area will be collected from the health facility's outpatient department (OPD) register and FCHV's register/logbook. Eligible women will be screened by the research assistant using the Patient Health Questionnaire (PHQ-9), a screening tool for depression consisting of 9 questions that has already been validated in Nepal. If the woman scores 10 or above in the screening tool, the research assistant will collect the baseline information within 1 week and will refer the woman to the respective FCHV from the same locality as the woman's. The FCHVs in the intervention arm will meet the woman, administer consent form regarding the "Thinking Healthy Programme" (THP). Participants providing consent will be engaged in the THP programme that will be delivered by the trained FCHV. The FCHVs in the control arm will meet the woman, provide psychoeducation, and refer to the health facility where mental health services are available.
- Conditions
- Perinatal Depression
- Being tested
- Thinking Healthy Programme
- Keywords
- perinatal depression, psychological intervention, nonspecialist, low and middle income countries, pilot cluster randomized control trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thinking Healthy ProgrammeBehavioural
The Thinking Healthy Programme (THP) is a psychological treatment recommended by the World Health Organization for perinatal depression. The THP is based on the basic tenets of cognitive behavioural therapy (CBT) that aims to identify unhealthy thoughts and the vicious effects it has on the emotions and behaviour of a person and transform to healthy thinking style that ultimately impacts one's emotions and behaviour, too. The intervention aims to bring positive outcomes in three areas - a) mother's health, b) the mother-baby relationship, and c) the mother's relationship with others. A randomized controlled trial (RCT) showed that the intervention was effective in reducing depressive symptoms and disability and improving functioning. Additionally, women receiving THP had higher rate of exclusive breastfeeding, and engaging more with their infants. Similarly, infants of these women were also less likely to have diarrhoeal episode and more likely to complete immunization.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm: Thinking Healthy Programme | Experimental | Perinatal women identified with depression in intervention arm will be engaged in 2 modules, one during pregnancy and one during postnatal. Each module has 3 sessions each focusing on a) mother's health, b) the mother-baby relationship, and c) the mother's relationship with others. Altogether 8 sessions (including 1 introductory session, 6 THP sessions, and 1 closing session) each lasting 30 minutes to 1 hour will be provided to intervention arm participants. In the third session of each module that deals with "the mother's relationship with others", family members will be engaged as well. Questionnaire evaluation will be conducted at baseline, post-Module 1 (after 2 months from recruitment date) and at 3 months post delivery after completing Module 2 and closing session. Receives: Behavioral: Thinking Healthy Programme |
| Control Arm: Usual Care | No intervention | Subjects in the control arm will receive usual care, where perinatal women identified with depression, are provided with psychoeducation about their condition and about the availability of services at the health facility and other health information. They will be then referred to the health facility where trained health workers are available. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Female Community Health Volunteers' clinical skills to provide psychological support
Competency of Female Community Health Volunteers will be assessed through Ensuring Quality in Psychological Support (EQUIP), an online platform consisting of a tool to assess clinical competency of mental health and psychosocial service providers. A service providers' competency is assessed in a Likert scale where 1 represents having harmful behaviour, 2 represents having any or none of the basic helping skills, 3 represents having all basic skills and 4 represents having any advanced skills.
Measured: From pre training to immediate post training
Qualitative Information: Feasibility from service providers' perspective
Service providers who deliver the Thinking Healthy Programme for duration of project will be asked through Focus Group Discussion and Key Informant Interviews about the feasibility of recruiting women with perinatal depression, delivering intervention in the community setting, engaging women, and their family members in the session.
Measured: Month 18
Qualitative Information: Feasibility from service users' perspective
Women with perinatal depression and their family members engaged in the Thinking Healthy Programme will be interviewed to explore feasibility in terms of engaging in the session, scheduling time for session, and completing tasks.
Measured: 3 months postnatal
Qualitative Information: Acceptability from service providers' perspective
Service providers who deliver the Thinking Healthy Programme for duration of project will be asked through Focus Group Discussion and Key Informant Interviews about their experience delivering intervention focusing on facilitators and barriers, perceived benefits and challenges of intervention for perinatal depression, and their willingness to engage as deliver agents in the future.
Measured: Month 18
Qualitative Information: Acceptability of of Thinking Healthy Programme from service users' perspective
Women with perinatal depression and their family members engaged in the Thinking Healthy Programme will be interviewed to explore facilitators and barriers to engage in the session, perceived benefits and challenges of receiving intervention in the home setting, and their perception of the service provider.
Measured: 3 months postnatal
Qualitative Information: Appropriateness of Thinking Healthy Programme from service providers' perspective
Service providers who deliver the Thinking Healthy Programme for duration of project will be asked through Focus Group Discussion and Key Informant Interviews about their perception towards the intervention, its utility, suitability in Nepali context.
Measured: Month 18
Qualitative Information: Appropriateness of Thinking Healthy Programme from service users' perspective
Women with perinatal depression and their family members engaged in the Thinking Healthy Programme will be interviewed to explore their perception towards the intervention, its utility, suitability for their problem.
Measured: 3 months postnatal
Secondary outcomes (11)
Changes in Patient Health Questionnaire-9+1
The PHQ-9 is a 9-item screening tool for depression used in various medical setting, and primary care setting. The tool has nine common symptoms of depression that should be rated by the respondent in a Likert scale where 0 stands for "not at all" to 3 "always". The symptoms are rated in relation to its occurrence and experience by the respondent in the past 2 weeks. The additional 1 question in PHQ9+1 is related to disability caused by depression. The tool has been translated and validated in a primary care population in Nepal. Symptoms severity will be assessed at baseline, 2 months post baseline and 3 months postnatal.
Measured: Baseline (M0), 2 months after baseline (M2), 3 months postnatal (M4-M8)
Changes in Generalized Anxiety Disorder Scale
A 7-item screening tool for anxiety that is rated by the respondent in a Likert scale where 0 stands for "not at all" to 3 "nearly every day". The tool has already been used in Nepal. Symptoms severity will be assessed at baseline, 2 months post baseline and 3 months postnatal.
Measured: Baseline (M0), 2 months after baseline (M2), 3 months postnatal (M4-M8)
Changes in World Health Organization's Disability Assessment Schedule
A 12-item tool that measures disability and functionality over the previous 30 days and has already been used in Nepal. Responses are rated in a scale where 1 means "none" and 5 means "extreme". Higher the score means higher the disability.
Measured: Baseline (M0), 2 months after baseline (M2), 3 months postnatal (M4-M8)
Changes in Alcohol Use Disorder Identification Test
Alcohol Use Disorder Identification Test is a screening tool to identify probable alcohol dependence or alcohol misuse. The tool has 10 questions divided into 3 conceptual domains. The first domain assesses recent alcohol consumption and contains 3 questions (frequency of consumption, typical amount, and frequency of heavy consumption). The second domain assesses symptoms of dependence through 3 questions (loss of control over consumption, increased relevance of consumption, and morning consumption). The third domain assesses harmful alcohol through 4 questions (Feeling of guilt after consumption, memory gaps, alcohol-related injuries and environmental concern about consumption). The tool has been validated in Nepal and a result equal to or greater than 9 is considered indicative of alcohol dependence or alcohol misuse.
Measured: Baseline (M0), 2 months after baseline (M2), 3 months postnatal (M4-M8)
Changes in Internalized Stigma of Mental Illness
The brief version of Internalized Stigma of Mental Illness tool has 9-items that explores self-stigmatization of persons with mental illness. Responses are recorded from 1-4 scale where 1 means "strongly disagree" and 4 means "strongly agree". Higher the score means greater experience of stigma. The tool has been previously validated and used in other studies in Nepal.
Measured: Baseline (M0), 2 months after baseline (M2), 3 months postnatal (M4-M8)
Changes in Multidimensional Scale of Perceived Social Support
The Multidimensional Scale of Perceived Social Support is a 12-item instrument which measures perceived support from three sources: Family, Friends and Significant Others. It consists of 4 items for each sources and each item is graded on a 7-item likert scale where 1 means "very strongly disagree" and 7 means "very strongly agree". Higher the score in the scale means having stronger social support system.
Measured: Baseline (M0), 2 months after baseline (M2), 3 months postnatal (M4-M8)
Suicide Assessment
Contains 9 structured questions in which the first 3 questions asks whether the person had suicidal thought, or plan or tried in the last 3 months. The questions only record occurrences of event with binary response options (Yes/No). Question no. 4 to 8 asks about whether medical attention was needed, whether the person has spoken to anyone, who they have spoken to, help sought, and treatment type. The last question asks about suicidal ideation at any point in their life in a yes/no option.
Measured: Baseline (M0), 2 months after baseline (M2), 3 months postnatal (M4-M8)
Antenatal care attendance
Four structured questions whether any antenatal visits were made (yes/no option), number of total visits, any health problems were seen (yes/no option), hospitalization was done (yes/no option).
Measured: Baseline (M0), 2 months after baseline (M2)
Domestic violence
Three structured questions with binary option (yes/no) about any occurrences of physical, or emotional, or sexual violence in the last three months.
Measured: Baseline (M0), 2 months after baseline (M2), 3 months postnatal (M4-M8)
Postnatal care attendance
Four structured questions whether any postnatal visits were made (yes/no option), number of total visits, any health problems were seen (yes/no option), hospitalization was done (yes/no option).
Measured: 3 months postnatal (M4-M8)
Exclusive breastfeeding
Four structured questions to indicate whether exclusive breastfeeding has been done. First question asks whether the breastfeeding is done (yes/no option), milk adequacy (yes/no option), breastfeeding frequency, and use of formulas (yes/no option).
Measured: 3 months postnatal (M4-M8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start15 Nov 2022
- Primary completion30 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The health facility is the unit of randomization. Altogether 4 health facilities will be selected for the study, where two health facilities will be allocated to each arm. The female community health volunteers (FCHVs) from the health facilities in the intervention arm will receive 10 days training on detection of perinatal depression and THP whilst the FCHVs from control arm will receive 3 days training on detection, psychoeducation, and referral.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Transcultural Psychosocial Organization Nepal
- Sponsor type
- University, hospital or other
- Collaborators
- University of Liverpool
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05393479
- Sponsor's protocol ID
- TPONepal
- Status last verified
- Aug 2023
- First submitted
- 26 Apr 2022
- Last updated
- 31 Aug 2023
- 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 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Acceptability, Appropriateness, and Preliminary Effectiveness of "Thinking Healthy Programme" for Perinatal Depression in Nepal: A Pilot Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05393479
- Acronym / sponsor ID
- TPONepal
- Conditions
- Perinatal Depression
- Keywords
- perinatal depression, psychological intervention, nonspecialist, low and middle income countries, pilot cluster randomized control trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Transcultural Psychosocial Organization NepalUniversity, hospital or other
- Collaborators
- University of Liverpool
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 26 May 2022 (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.
As many as 1 in 3 women in Nepal suffer from perinatal depression however, they often go unidentified and untreated. Lack of knowledge limited trained human resources, and unavailability of specific maternal mental health services are some of the major barriers impeding help-seeking. To mitigate this gap, the World Health Organization recommended Thinking Healthy Programme (THP), a psychological intervention that can be delivered by non-specialists and has been proven effective for perinatal depression in a resource constrained context. The THP has already been translated and adapted to Nepali context. In this study, the investigators plan to pilot test the intervention and assess its feasibility, acceptability, appropriateness, and preliminary effectiveness when delivered by the Female Community Health Volunteers (FCHVs). The FCHVs are cadre of Nepal Government mobilized for the prevention and promotion of maternal and child health in the community level.
Detailed description
The Thinking Healthy Programme (THP) is a community based low-intensity psychosocial intervention tailored for perinatal depression in improving outcomes in three areas - a) mother's health, b) the mother-baby relationship, and c) the mother's relationship with others. The intervention has already been tested in other South Asian context and has been found effective in reducing depressive symptoms and promoting wellbeing even when delivered by a non-specialist with limited education. The intervention is basic and does not require prior knowledge or experience on mental health however, it is preferred that the deliverer should at least know about basics of maternal and childcare. In a resource poor country like Nepal where the investment and human resource for maternal mental health is scanty despite the high burden, the THP can be promising given its effectiveness and cost-effectiveness. The THP has already been adapted to the Nepali context.
For the pilot-testing of THP, 4 health facilities will be selected. The health facilities will be randomized to intervention and control arm (2 health facilities in each arm). A list of pregnant women from the health facility's and FCHV's catchment area will be collected from the health facility's outpatient department (OPD) register and FCHV's register/logbook. Eligible women will be screened by the research assistant using the Patient Health Questionnaire (PHQ-9), a screening tool for depression consisting of 9 questions that has already been validated in Nepal. If the woman scores 10 or above in the screening tool, the research assistant will collect the baseline information within 1 week and will refer the woman to the respective FCHV from the same locality as the woman's. The FCHVs in the intervention arm will meet the woman, administer consent form regarding the "Thinking Healthy Programme" (THP). Participants providing consent will be engaged in the THP programme that will be delivered by the trained FCHV. The FCHVs in the control arm will meet the woman, provide psychoeducation, and refer to the health facility where mental health services are available.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The health facility is the unit of randomization. Altogether 4 health facilities will be selected for the study, where two health facilities will be allocated to each arm. The female community health volunteers (FCHVs) from the health facilities in the intervention arm will receive 10 days training on detection of perinatal depression and THP whilst the FCHVs from control arm will receive 3 days training on detection, psychoeducation, and referral.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm: Thinking Healthy Programme | Experimental | Behavioral: Thinking Healthy ProgrammePerinatal women identified with depression in intervention arm will be engaged in 2 modules, one during pregnancy and one during postnatal. Each module has 3 sessions each focusing on a) mother's health, b) the mother-baby relationship, and c) the mother's relationship with others. Altogether 8 sessions (including 1 introductory session, 6 THP sessions, and 1 closing session) each lasting 30 minutes to 1 hour will be provided to intervention arm participants. In the third session of each module that deals with "the mother's relationship with others", family members will be engaged as well. Questionnaire evaluation will be conducted at baseline, post-Module 1 (after 2 months from recruitment date) and at 3 months post delivery after completing Module 2 and closing session. |
| Control Arm: Usual Care | No intervention | –Subjects in the control arm will receive usual care, where perinatal women identified with depression, are provided with psychoeducation about their condition and about the availability of services at the health facility and other health information. They will be then referred to the health facility where trained health workers are available. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Pregnant women
- Should be residing in the FCHV's catchment area
- Should be between 4-7 months pregnant.
- Should have no severe physical health conditions
- Should have depressive symptoms (scores 10 or higher in PHQ-9).
Key exclusion criteria (1 listed)
- Women reporting miscarriage, abortion, or still birth will be excluded from the THP intervention (but referred to the psychosocial counsellor for further care)
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 |
|---|---|---|
| Thinking Healthy ProgrammeThe Thinking Healthy Programme (THP) is a psychological treatment recommended by the World Health Organization for perinatal depression. The THP is based on the basic tenets of cognitive behavioural therapy (CBT) that aims to identify unhealthy thoughts and the vicious effects it has on the emotions and behaviour of a person and transform to healthy thinking style that ultimately impacts one's emotions and behaviour, too. The intervention aims to bring positive outcomes in three areas - a) mother's health, b) the mother-baby relationship, and c) the mother's relationship with others. A randomized controlled trial (RCT) showed that the intervention was effective in reducing depressive symptoms and disability and improving functioning. Additionally, women receiving THP had higher rate of exclusive breastfeeding, and engaging more with their infants. Similarly, infants of these women were also less likely to have diarrhoeal episode and more likely to complete immunization. | Behavioural | Intervention Arm: Thinking Healthy Programme |
Primary outcome
Change in Female Community Health Volunteers' clinical skills to provide psychological support
Time frame: From pre training to immediate post training
Competency of Female Community Health Volunteers will be assessed through Ensuring Quality in Psychological Support (EQUIP), an online platform consisting of a tool to assess clinical competency of mental health and psychosocial service providers. A service providers' competency is assessed in a Likert scale where 1 represents having harmful behaviour, 2 represents having any or none of the basic helping skills, 3 represents having all basic skills and 4 represents having any advanced skills.
Qualitative Information: Feasibility from service providers' perspective
Time frame: Month 18
Service providers who deliver the Thinking Healthy Programme for duration of project will be asked through Focus Group Discussion and Key Informant Interviews about the feasibility of recruiting women with perinatal depression, delivering intervention in the community setting, engaging women, and their family members in the session.
Qualitative Information: Feasibility from service users' perspective
Time frame: 3 months postnatal
Women with perinatal depression and their family members engaged in the Thinking Healthy Programme will be interviewed to explore feasibility in terms of engaging in the session, scheduling time for session, and completing tasks.
Qualitative Information: Acceptability from service providers' perspective
Time frame: Month 18
Service providers who deliver the Thinking Healthy Programme for duration of project will be asked through Focus Group Discussion and Key Informant Interviews about their experience delivering intervention focusing on facilitators and barriers, perceived benefits and challenges of intervention for perinatal depression, and their willingness to engage as deliver agents in the future.
Qualitative Information: Acceptability of of Thinking Healthy Programme from service users' perspective
Time frame: 3 months postnatal
Women with perinatal depression and their family members engaged in the Thinking Healthy Programme will be interviewed to explore facilitators and barriers to engage in the session, perceived benefits and challenges of receiving intervention in the home setting, and their perception of the service provider.
Qualitative Information: Appropriateness of Thinking Healthy Programme from service providers' perspective
Time frame: Month 18
Service providers who deliver the Thinking Healthy Programme for duration of project will be asked through Focus Group Discussion and Key Informant Interviews about their perception towards the intervention, its utility, suitability in Nepali context.
Qualitative Information: Appropriateness of Thinking Healthy Programme from service users' perspective
Time frame: 3 months postnatal
Women with perinatal depression and their family members engaged in the Thinking Healthy Programme will be interviewed to explore their perception towards the intervention, its utility, suitability for their problem.
11 secondary outcomes
Changes in Patient Health Questionnaire-9+1
Time frame: Baseline (M0), 2 months after baseline (M2), 3 months postnatal (M4-M8)
Changes in Generalized Anxiety Disorder Scale
Time frame: Baseline (M0), 2 months after baseline (M2), 3 months postnatal (M4-M8)
Changes in World Health Organization's Disability Assessment Schedule
Time frame: Baseline (M0), 2 months after baseline (M2), 3 months postnatal (M4-M8)
Changes in Alcohol Use Disorder Identification Test
Time frame: Baseline (M0), 2 months after baseline (M2), 3 months postnatal (M4-M8)
Changes in Internalized Stigma of Mental Illness
Time frame: Baseline (M0), 2 months after baseline (M2), 3 months postnatal (M4-M8)
Changes in Multidimensional Scale of Perceived Social Support
Time frame: Baseline (M0), 2 months after baseline (M2), 3 months postnatal (M4-M8)
Suicide Assessment
Time frame: Baseline (M0), 2 months after baseline (M2), 3 months postnatal (M4-M8)
Antenatal care attendance
Time frame: Baseline (M0), 2 months after baseline (M2)
Domestic violence
Time frame: Baseline (M0), 2 months after baseline (M2), 3 months postnatal (M4-M8)
Postnatal care attendance
Time frame: 3 months postnatal (M4-M8)
Exclusive breastfeeding
Time frame: 3 months postnatal (M4-M8)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thinking Healthy Programme in people with Perinatal Depression, run by Transcultural Psychosocial Organization Nepal at 1 site in Nepal.
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 31 Aug 2023. 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 Nepal. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Female Community Health Volunteers' clinical skills to provide psychological support (time frame: From pre training to immediate post training). The study lists 7 primary outcomes in all. 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 31 Aug 2023.