Mental DisordersNCT03544450
Effectiveness of Non-medical Health Worker (NMHW) Led Counseling on Common Mental Disorders in Rural Mid-western Nepal
A study testing Psychosocial counselling in people with Mental Disorders and Psychological Distress, run by Centre for Victims of Torture, Nepal.
Trial summary
Psychological treatments may be provided by non-medical health workers (NMHW) to increase accessibility. Task shifting of screening and treatment of non-communicable diseases to non-medical health workers is both effective and cost-effective. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Mental Disorders, Psychological Distress, Depression
- What is being tested?
- Psychosocial counselling
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 287 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Dec 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 16
- GHQ-12 ≥ 6
- Willing to participate in the intervention and research program
- Able to communicate fluently in Nepali and to participate the required visits
- Resident in Dang for the subsequent 10 months
Who cannot join
- Age < 16
- GHQ-12 < 6
- Signs of severe mental health problems (i.e., psychotic features)
- Severe illnesses or conditions requiring immediate attentions( i.e., suicidal)
- Not willing to participate in the intervention and research program
About this study
Psychological treatments may be provided by non-medical health workers (NMHW) to increase accessibility. Task shifting of screening and treatment of non-communicable diseases to non-medical health workers is both effective and cost-effective. A recent review included five randomized controlled trials to assess effectiveness of NMHW provided psychological interventions to treat common mental disorders and depression, and all five trials found the intervention beneficial over usual treatment.
The aim of this study is to assess the effectiveness of psychosocial counselling as practiced by non-medical psychosocial counsellors in improving the outcomes of persons with common mental disorders in a primary health care setting.
Read more
Patients with psychosocial distress will be randomized to receive either counseling + enhanced usual care or enhanced usual care by health workers. The hypothesis is that adding psychosocial counselling to enhanced usual care, will be more effective than enhanced care alone in reducing the symptoms of depression, anxiety and posttraumatic stress disorder and in improving day-to-day functioning of clients receiving services in primary health care settings.
If proven effective, non-medical health worker led counseling could be an affordable treatment to alleviate psychological suffering and improve functional capacity of Nepalese people.
Read the detailed description
Statement of problem
Psychosocial interventions, such as counselling, are effective in improving social functioning in common mental disorders. Specifically, culturally adapted psychological treatments are effective in the treatment of depression, according to a recent meta-analysis.
Psychological treatments may be provided by non-medical health workers (NMHW) to increase accessibility. Task-shifting of screening and treatment of non-communicable diseases to non-medical health workers is both effective and cost-effective. A recent review included five randomized controlled trials to assess effectiveness of NMHW provided psychological interventions to treat common mental disorders and depression, and all five trials found the intervention beneficial over usual treatment.
In the MANAS trial in India, for example, those receiving the intervention were 55% more likely to recover from common mental disorders than the control group in public health facilities. The stepped-care intervention was provided by NMHWs who had received a two-month training in counselling. In Pakistan, a psychological treatment delivered by Lady Health Workers (NMHWs) resulted in 78% reduction in maternal depression, compared with usual care.
In Nepal, the need for psychosocial interventions led by NMHWs is high because of the very limited number of mental health professionals. Centre for Victims of Torture (CVICT) has extensive experience in developing psychosocial counseling services and training counsellors. CVICT has experienced that even a short intervention, including only 1-5 counselling sessions, leads to decreased mental distress. Positive feedback has been given both by the patients and the people working in primary health care. However, no rigorous research has been conducted on the effectiveness of counselling on the symptoms of common mental disorders. This will be the first study comparing the effectiveness of psychosocial counseling and enhanced usual care to enhanced usual in rural Nepal.
Conceptual framework
This trial will examine the added value of psychosocial counseling in individuals with psychological distress when provided together with enhanced usual care in rural health posts.
The psychosocial approach emphasizes the close connection between psychological aspects of an individual's experience (namely, thoughts, feelings and beliefs) and the wider social experience (namely, relationships with family, community and friends) as well as the broader social environment (i.e. culture, traditions, religion, socio-political environment). There is a dynamic relationship between the psychological and social effects of experiences on the individual person, with each continually influencing the other.
Psychosocial counselling starts with the complaints that a client brings into the session, and is aimed at decreasing disability. The client is assisted in dealing with problems himself/herself within a counselling process, or is sometimes referred to other existing resources if the counsellor feels that to be more appropriate. Specifically, the counselling process consists of: (i) introduction, explanation and rapport building; (ii) assessment of and understanding of the problem (including looking for positive assets); (iii) goal setting (asking the client what outcomes are preferred); (iv) problem management (exploring and identifying solutions, brainstorming, working with existing coping strategies, using social and cultural resources, and additional techniques such as relaxation and psycho-education); (v) implementation (making a plan of action and transition); and, finally, (vi) termination of counselling (including closing and follow-up). This process helps to reduce psychological distress experienced by the patients and is practiced by trained psychosocial counselors.
Enhanced usual care is provided by health workers, who have already been trained on diagnosis and treatment of common mental disorders, and usage of basic psychosocial counseling skills (communication, listening and basic emotional support).
It is important to note that in this conceptual framework psychosocial counselling is just one part of the spectrum of psychosocial care and dealing with distress in Nepal's context where there are other issues such as poverty, human rights abuses, gender based violence etc.
General objective
To assess the effectiveness of psychosocial counseling as practiced by non-medical psychosocial counselors in improve the outcomes of persons with common health disorders in primary health care setting.
Specific objective
To assess the effectiveness of psychosocial counselling on:
- reducing symptoms of depression and anxiety
- improving functional capacity
- improving coping and use of available resources
To assess acceptability of psychosocial counseling.
Study variables
Depressive symptoms, anxiety symptoms, coping mechanisms and usage of available resources, functional capacity
Covariates: Demographic variable (gender, age, socioeconomic position)
Study population
Residents of Dang
Study units
Individuals
Sampling methods
As this is a randomized controlled trial, randomization will be done using a randomization table. Participants coming to the health post for treatment of symptoms of psychological distress will be potential participants for this research. Individuals referred by the counselors during their field mental health promotion work will also be potential participants for this research. Individuals will be screened with the General Health Questionnaire (GHQ-12, validated Nepali version, and those who score 6 or more on will be invited to participate in the study. The Research Assistant will use the GHQ. In the Nepali context, score of 6 or more in the GHQ-12 reveals psychological distress. The GHQ-12 was validated using Likert scale in Nepal. Randomization will be done by a health worker at the health post. Research Assistant will be blinded to the study.
Sampling size
A sample size of 132 in each group will be required to detect a clinically important difference of three points on the Beck scale of depression (BDI: Beck Depression Inventory), using a two-tailed test of the difference between means and a power of 80%, and a significance level of 5%. Based on a previous study, we assume a standard deviation of 8.7 for BDI and also the calculation is based on the assumption that the measurements on BDI are normally distributed. However, considering the possible 30% dropout rates, we will need to recruit 176 individuals per group, 352 in total.
Data collection technique
Data will be collected on paper and stored safely in lockers. No names will appear on study forms. All participants will be read out consent forms and asked to sign on the form. All questions of the data tools will be read aloud and participants will be asked to choose which level they agree with on Likert's scale. RA's data and counselors data will be kept separately. Study coordinator will enter data into SPSS bi-weekly. Participants will be referred by the project counselors, female community health volunteers and health workers of other health posts to the centres for study/ treatment.
Data collection tools
For the Quantitative study, questionnaires will be used to collect the data from each group. The questionnaire will have five sections. The sections are: Socio and Demographic information, Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), World Health Organization Disability Assessment Schedule-II (WHODAS-II) and Resource and Coping Mechanism will be used. All in all tools are validated in Nepal and study area (Dang), availed in Nepali language and used by CVICT in their previous Research.
- Conditions
- Mental Disorders, Psychological Distress, Depression, Anxiety, Coping
- Being tested
- Psychosocial counselling, Enhanced Usual Care
- Medical subject headings
- Mental Disorders, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial counsellingBehavioural
Individuals with psychological distress receive psychosocial counselling and enhanced usual care. The psychosocial the counselling process consists of: (i) introduction, explanation and rapport building; (ii) assessment of and understanding of the problem (including looking for positive assets); (iii) goal setting (asking the client what outcomes are preferred); (iv) problem management (exploring and identifying solutions, brainstorming, working with existing coping strategies, using social and cultural resources, and additional techniques such as relaxation and psycho-education); (v) implementation (making a plan of action and transition); and, finally, (vi) termination of counselling (including closing and follow-up)." Enhanced usual care is provided by health workers, who have already been trained on diagnosis and treatment of common mental disorders, and usage of basic psychosocial counseling skills (communication, listening and basic emotional support).
Enhanced Usual CareOther
Enhanced usual care is provided by health workers, who have already been trained on diagnosis and treatment of common mental disorders, and usage of basic psychosocial counseling skills (communication, listening and basic emotional support).
| Study group | Role | What they receive |
|---|---|---|
| Psychosocial counselling + Enhanced usual care (EUC) | Experimental | This arm receives psychosocial counselling from the counsellor as well as enhanced usual care from health worker Receives: Behavioral: Psychosocial counselling; Other: Enhanced Usual Care |
| Enhanced Usual Care (EUC) | Active comparator | This arm receives enhanced usual care from health worker Receives: Other: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of participants who have a response to treatment when assessed by change in the symptoms of depressive symptoms measured by Beck Depression Inventory
The range of scale is 0-63 scores and higher scores indicate higher levels of depression. Reduction of 50% or more from initial BDI score indicates response. The instrument is used at baseline, 1 month and 6 months in both groups.
Measured: 0 months, 1 month, 6 months
Secondary outcomes (3)
Change in the symptoms of anxiety assessed by Beck Anxiety Inventory
The range of scale is 0-63 scores and higher scores indicate higher levels of anxiety. The instrument is used at baseline, 1 month and 6 months in both groups.
Measured: 0 months, 1 month, 6 months
Change in the functional capacity assessed by World Health Organisation Disability Assessment Schedule - II
The validated Nepali version of WHODAS-II includes 13 questions and the range of scale is 13-65 scores. Higher scores indicate lower level of functional capacity. The instrument is used at baseline, 1 month and 6 months in both groups.
Measured: 0 months, 1 month, 6 months
Change in the symptoms of depression assessed by Beck Depression Inventory
The range of scale is 0-63 scores and higher scores indicate higher levels of depression. The instrument is used at baseline, 1 month and 6 months in both groups.
Measured: 0 months, 1 month, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study startMay 2016
- Primary completionAug 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mental DisordersStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Victims of Torture, Nepal
- Sponsor type
- University, hospital or other
- Collaborators
- Physicians for Social Responsibility, Finland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03544450
- Sponsor's protocol ID
- CounselingCvict
- Status last verified
- Jun 2018
- First submitted
- 25 Apr 2016
- Last updated
- 11 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Patel V, Weiss HA, Chowdhary N, Naik S, Pednekar S, Chatterjee S, De Silva MJ, Bhat B, Araya R, King M, Simon G, Verdeli H, Kirkwood BR. Effectiveness of an intervention led by lay health counsellors for depressive and anxiety disorders in primary care in Goa, India (MANAS): a cluster randomised controlled trial. Lancet. 2010 Dec 18;376(9758):2086-95. doi: 10.1016/S0140-6736(10)61508-5. Epub 2010 Dec 13.
PubMed 21159375Tol WA, Jordans MJ, Regmi S, Sharma B. Cultural challenges to psychosocial counselling in Nepal. Transcult Psychiatry. 2005 Jun;42(2):317-33. doi: 10.1177/1363461505052670.
PubMed 16114588
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Non-medical Health Worker (NMHW) Led Counseling on Common Mental Disorders in Rural Mid-western Nepal
- ClinicalTrials.gov ID
- NCT03544450
- Acronym / sponsor ID
- CounselingCvict
- Conditions
- Mental Disorders, Psychological Distress, Depression, Anxiety, Coping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- Centre for Victims of Torture, NepalUniversity, hospital or other
- Collaborators
- Physicians for Social Responsibility, Finland
- Study start
- May 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 1 Jun 2018 (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.
Psychological treatments may be provided by non-medical health workers (NMHW) to increase accessibility. Task shifting of screening and treatment of non-communicable diseases to non-medical health workers is both effective and cost-effective. A recent review included five randomized controlled trials to assess effectiveness of NMHW provided psychological interventions to treat common mental disorders and depression, and all five trials found the intervention beneficial over usual treatment.
The aim of this study is to assess the effectiveness of psychosocial counselling as practiced by non-medical psychosocial counsellors in improving the outcomes of persons with common mental disorders in a primary health care setting.
Patients with psychosocial distress will be randomized to receive either counseling + enhanced usual care or enhanced usual care by health workers. The hypothesis is that adding psychosocial counselling to enhanced usual care, will be more effective than enhanced care alone in reducing the symptoms of depression, anxiety and posttraumatic stress disorder and in improving day-to-day functioning of clients receiving services in primary health care settings.
If proven effective, non-medical health worker led counseling could be an affordable treatment to alleviate psychological suffering and improve functional capacity of Nepalese people.
Detailed description
Statement of problem
Psychosocial interventions, such as counselling, are effective in improving social functioning in common mental disorders. Specifically, culturally adapted psychological treatments are effective in the treatment of depression, according to a recent meta-analysis.
Psychological treatments may be provided by non-medical health workers (NMHW) to increase accessibility. Task-shifting of screening and treatment of non-communicable diseases to non-medical health workers is both effective and cost-effective. A recent review included five randomized controlled trials to assess effectiveness of NMHW provided psychological interventions to treat common mental disorders and depression, and all five trials found the intervention beneficial over usual treatment.
In the MANAS trial in India, for example, those receiving the intervention were 55% more likely to recover from common mental disorders than the control group in public health facilities. The stepped-care intervention was provided by NMHWs who had received a two-month training in counselling. In Pakistan, a psychological treatment delivered by Lady Health Workers (NMHWs) resulted in 78% reduction in maternal depression, compared with usual care.
In Nepal, the need for psychosocial interventions led by NMHWs is high because of the very limited number of mental health professionals. Centre for Victims of Torture (CVICT) has extensive experience in developing psychosocial counseling services and training counsellors. CVICT has experienced that even a short intervention, including only 1-5 counselling sessions, leads to decreased mental distress. Positive feedback has been given both by the patients and the people working in primary health care. However, no rigorous research has been conducted on the effectiveness of counselling on the symptoms of common mental disorders. This will be the first study comparing the effectiveness of psychosocial counseling and enhanced usual care to enhanced usual in rural Nepal.
Conceptual framework
This trial will examine the added value of psychosocial counseling in individuals with psychological distress when provided together with enhanced usual care in rural health posts.
The psychosocial approach emphasizes the close connection between psychological aspects of an individual's experience (namely, thoughts, feelings and beliefs) and the wider social experience (namely, relationships with family, community and friends) as well as the broader social environment (i.e. culture, traditions, religion, socio-political environment). There is a dynamic relationship between the psychological and social effects of experiences on the individual person, with each continually influencing the other.
Psychosocial counselling starts with the complaints that a client brings into the session, and is aimed at decreasing disability. The client is assisted in dealing with problems himself/herself within a counselling process, or is sometimes referred to other existing resources if the counsellor feels that to be more appropriate. Specifically, the counselling process consists of: (i) introduction, explanation and rapport building; (ii) assessment of and understanding of the problem (including looking for positive assets); (iii) goal setting (asking the client what outcomes are preferred); (iv) problem management (exploring and identifying solutions, brainstorming, working with existing coping strategies, using social and cultural resources, and additional techniques such as relaxation and psycho-education); (v) implementation (making a plan of action and transition); and, finally, (vi) termination of counselling (including closing and follow-up). This process helps to reduce psychological distress experienced by the patients and is practiced by trained psychosocial counselors.
Enhanced usual care is provided by health workers, who have already been trained on diagnosis and treatment of common mental disorders, and usage of basic psychosocial counseling skills (communication, listening and basic emotional support).
It is important to note that in this conceptual framework psychosocial counselling is just one part of the spectrum of psychosocial care and dealing with distress in Nepal's context where there are other issues such as poverty, human rights abuses, gender based violence etc.
General objective
To assess the effectiveness of psychosocial counseling as practiced by non-medical psychosocial counselors in improve the outcomes of persons with common health disorders in primary health care setting.
Specific objective
To assess the effectiveness of psychosocial counselling on:
- reducing symptoms of depression and anxiety
- improving functional capacity
- improving coping and use of available resources
To assess acceptability of psychosocial counseling.
Study variables
Depressive symptoms, anxiety symptoms, coping mechanisms and usage of available resources, functional capacity
Covariates: Demographic variable (gender, age, socioeconomic position)
Study population
Residents of Dang
Study units
Individuals
Sampling methods
As this is a randomized controlled trial, randomization will be done using a randomization table. Participants coming to the health post for treatment of symptoms of psychological distress will be potential participants for this research. Individuals referred by the counselors during their field mental health promotion work will also be potential participants for this research. Individuals will be screened with the General Health Questionnaire (GHQ-12, validated Nepali version, and those who score 6 or more on will be invited to participate in the study. The Research Assistant will use the GHQ. In the Nepali context, score of 6 or more in the GHQ-12 reveals psychological distress. The GHQ-12 was validated using Likert scale in Nepal. Randomization will be done by a health worker at the health post. Research Assistant will be blinded to the study.
Sampling size
A sample size of 132 in each group will be required to detect a clinically important difference of three points on the Beck scale of depression (BDI: Beck Depression Inventory), using a two-tailed test of the difference between means and a power of 80%, and a significance level of 5%. Based on a previous study, we assume a standard deviation of 8.7 for BDI and also the calculation is based on the assumption that the measurements on BDI are normally distributed. However, considering the possible 30% dropout rates, we will need to recruit 176 individuals per group, 352 in total.
Data collection technique
Data will be collected on paper and stored safely in lockers. No names will appear on study forms. All participants will be read out consent forms and asked to sign on the form. All questions of the data tools will be read aloud and participants will be asked to choose which level they agree with on Likert's scale. RA's data and counselors data will be kept separately. Study coordinator will enter data into SPSS bi-weekly. Participants will be referred by the project counselors, female community health volunteers and health workers of other health posts to the centres for study/ treatment.
Data collection tools
For the Quantitative study, questionnaires will be used to collect the data from each group. The questionnaire will have five sections. The sections are: Socio and Demographic information, Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), World Health Organization Disability Assessment Schedule-II (WHODAS-II) and Resource and Coping Mechanism will be used. All in all tools are validated in Nepal and study area (Dang), availed in Nepali language and used by CVICT in their previous Research.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychosocial counselling + Enhanced usual care (EUC) | Experimental | Behavioral: Psychosocial counselling, Other: Enhanced Usual CareThis arm receives psychosocial counselling from the counsellor as well as enhanced usual care from health worker |
| Enhanced Usual Care (EUC) | Active comparator | Other: Enhanced Usual CareThis arm receives enhanced usual care from health worker |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 16
- GHQ-12 ≥ 6
- Willing to participate in the intervention and research program
- Able to communicate fluently in Nepali and to participate the required visits
- Resident in Dang for the subsequent 10 months
Key exclusion criteria (5 listed)
- Age < 16
- GHQ-12 < 6
- Signs of severe mental health problems (i.e., psychotic features)
- Severe illnesses or conditions requiring immediate attentions( i.e., suicidal)
- Not willing to participate in the intervention and research program
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 |
|---|---|---|
| Psychosocial counsellingIndividuals with psychological distress receive psychosocial counselling and enhanced usual care. The psychosocial the counselling process consists of: (i) introduction, explanation and rapport building; (ii) assessment of and understanding of the problem (including looking for positive assets); (iii) goal setting (asking the client what outcomes are preferred); (iv) problem management (exploring and identifying solutions, brainstorming, working with existing coping strategies, using social and cultural resources, and additional techniques such as relaxation and psycho-education); (v) implementation (making a plan of action and transition); and, finally, (vi) termination of counselling (including closing and follow-up)." Enhanced usual care is provided by health workers, who have already been trained on diagnosis and treatment of common mental disorders, and usage of basic psychosocial counseling skills (communication, listening and basic emotional support). | Behavioural | Psychosocial counselling + Enhanced usual care (EUC) |
| Enhanced Usual CareEnhanced usual care is provided by health workers, who have already been trained on diagnosis and treatment of common mental disorders, and usage of basic psychosocial counseling skills (communication, listening and basic emotional support). | Other | Enhanced Usual Care (EUC), Psychosocial counselling + Enhanced usual care (EUC) |
Primary outcome
The proportion of participants who have a response to treatment when assessed by change in the symptoms of depressive symptoms measured by Beck Depression Inventory
Time frame: 0 months, 1 month, 6 months
The range of scale is 0-63 scores and higher scores indicate higher levels of depression. Reduction of 50% or more from initial BDI score indicates response. The instrument is used at baseline, 1 month and 6 months in both groups.
3 secondary outcomes
Change in the symptoms of anxiety assessed by Beck Anxiety Inventory
Time frame: 0 months, 1 month, 6 months
Change in the functional capacity assessed by World Health Organisation Disability Assessment Schedule - II
Time frame: 0 months, 1 month, 6 months
Change in the symptoms of depression assessed by Beck Depression Inventory
Time frame: 0 months, 1 month, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2018.
- Background: PubMed 21159375Patel V, Weiss HA, Chowdhary N, Naik S, Pednekar S, Chatterjee S, De Silva MJ, Bhat B, Araya R, King M, Simon G, Verdeli H, Kirkwood BR. Effectiveness of an intervention led by lay health counsellors for depressive and anxiety disorders in primary care in Goa, India (MANAS): a cluster randomised controlled trial. Lancet. 2010 Dec 18;376(9758):2086-95. doi: 10.1016/S0140-6736(10)61508-5. Epub 2010 Dec 13.
- Background: PubMed 16114588Tol WA, Jordans MJ, Regmi S, Sharma B. Cultural challenges to psychosocial counselling in Nepal. Transcult Psychiatry. 2005 Jun;42(2):317-33. doi: 10.1177/1363461505052670.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Psychosocial counselling in people with Mental Disorders and Psychological Distress, run by Centre for Victims of Torture, 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 5 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: finished, as of the sponsor's last update on 11 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The proportion of participants who have a response to treatment when assessed by change in the symptoms of depressive symptoms measured by Beck Depression Inventory (time frame: 0 months, 1 month, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03544450, which also lists 2 linked publications.
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 11 Jun 2018.