Depression, AnxietyNCT05290142
Pre-and-post Study With a Nested Randomized Trial of Digital Training to Teach Problem-solving Counselling in India
A study testing Digital Training with Coaching (DT-C) and Self-Guided Digital Training in people with Depression, Anxiety, run by Sangath at 9 sites in India.
Trial summary
This study is part of a Wellcome Trust-funded research program in India called PRIDE (PRemIum for aDolEscents, 2016-2022) led by Principal Investigator Prof. Vikram Patel (Harvard Medical School). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Digital Training with Coaching (DT-C) and Self-Guided Digital Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 277 participants
- Where
- 9 sitesIndia
- Study dates
- 6 Apr 2022to 16 Aug 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or above
- Associated with one of the partner organizations/institutes
- Access to an internet-enabled smartphone or computer device
- Provides consent to participate
Who cannot join
- Prior practice-based education and/or training in psychotherapy or mental health interventions.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
India9 sites
Acharya Institue
Bangalore, Karnataka, 560107
Christ University
Ghaziabad, Uttar Pradesh, 201003
Maniben Nanavati Women's College
Mumbai, Maharashtra, 110024
Ballygunj Society for Children in Pain
Mumbai, Maharashtra, 400104
Al-Falah University
New Delhi, National Capital Territory of Delhi, 110025
Agragami India
New Delhi, National Capital Territory of Delhi, 110076
Youth for Mental Health
New Delhi, National Capital Territory of Delhi, 110092
World Health Partners
New Delhi, 110074
YP Foundation
Noida, Uttar Pradesh, 201301
About this study
Official title: A Pre-and-post Study With a Nested Randomised Controlled Trial of Coach Versus Self-guided Digital Training in a Youth-focused Problem-solving Intervention
This study is part of a Wellcome Trust-funded research program in India called PRIDE (PRemIum for aDolEscents, 2016-2022) led by Principal Investigator Prof. Vikram Patel (Harvard Medical School). The goal of PRIDE is to establish a suite of scalable psychosocial interventions for common adolescent mental health problems in India.
Following on from earlier studies to develop and evaluate the various PRIDE interventions in school settings, the current study aims to generate evidence on methods to support implementation. We will undertake a pre-and-post study design with a nested randomized controlled trial with the specific aims to:
- Evaluate the effects of digital training on non-specialists' competency to deliver an evidence-based problem-solving intervention for common adolescent mental health problems
- Evaluate the incremental effect of digital training with coaching (DT-C) in comparison with self-guided digital training (DT) on non-specialists' competency to deliver an evidence-based problem-solving intervention for common adolescent mental health problems
- Evaluate the processes affecting the implementation of training interventions in both arms
Read the detailed description
PRIDE has been implemented in India to address the scarcity of evidence- based interventions for common adolescent mental health problems nationally and in low-resource settings more widely (Michelson et al., 2020). The goal is to develop and evaluate a suite of scalable, transdiagnostic psychological interventions (i.e., suitable for a variety of mental health presentations) that can be delivered by non-specialist ('lay') counsellors in resource-poor school settings.
There is a major knowledge gap concerning how to build capacity outside of specialist health settings and how to motivate and support non-specialists through structured capacity building activities in absence of adequate specialist trainers.
Hence, the aim of the current study is to evaluate the effectiveness of a digital training for non-specialists to improve their competency in delivering an evidence-based adolescent mental health intervention.
SIGNIFICANCE:
The health care system in India faces a number of key challenges: (1) poor quality and inadequately resourced primary health care; (2) low numbers and unequally distributed skilled human resources; (3) a large, unregulated, private sector; (4) low public spending on health leading to high levels of out of pocket expenditure; (5) fragmented health information systems; (6) irrational use and spiralling costs of drugs and technology; and (7) weak governance and accountability.
The current study will address the dearth of evidence on workforce development strategies necessary to scale-up evidence-based adolescent mental health interventions in low-resource settings.
- Conditions
- Depression, Anxiety
- Being tested
- Digital Training with Coaching (DT-C), Self-Guided Digital Training
- Keywords
- digital training, mental health intervention, adolescent mental health, non-specialists
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Training with Coaching (DT-C)Other
An identical digital training course and helpline will be available for the participants in this group. In addition to receiving the same digital training resources as the DT group, participants in DT-C will receive weekly individualized telephone calls from a coach who will motivate them and troubleshoot towards course completion. The focus will be on clarifying learning objectives and redirecting participants to relevant materials rather than providing new learning opportunities. Participants will also be able to send text messages to coaches with queries related to course content, progress and technical difficulties. Coaches will reply to participants' messages within one working day and send reminders about upcoming telephone sessions, as well as prompts if the participant has not logged into the course for 3 consecutive days.
Self-Guided Digital TrainingOther
Participants will be enrolled in a digital training course that addresses non-specific counselling skills and skills specific to an evidence-based problem-solving intervention. The course will be available offline and online on a smartphone app (called 'Sangath Training') as well as a website (https://training.sangath.in/login/index.php) that can be accessed through an internet-enabled device. The training will be delivered through didactic lectures, role-play demonstrations, and recommended readings spread across 16 modules. Participants will be provided with automated feedback on their learning through self-assessment quizzes after each module. Modules will be available sequentially and unlocked after accessing all content in the preceding module, over a period of 4 weeks. Technical helpline: Participants will also have an option to message a centralized helpline for assistance with accessing and navigating the digital interface.
| Study group | Role | What they receive |
|---|---|---|
| Self-Guided Digital Training (DT) | Active comparator | Participants will be enrolled in a digital training course that addresses non-specific counselling skills and skills specific to an evidence-based problem-solving intervention. The course will be available online on a smartphone app as well as a website that can be accessed through an internet-enabled device.
Participants will also have an option to message a centralized helpline for assistance with accessing and navigating the digital interface. Receives: Other: Self-Guided Digital Training |
| Digital Training with Coaching (DT-C) | Experimental | In addition to receiving the same digital training resources as the DT group, participants in DT-C will receive weekly individualized telephone calls from a coach who will motivate them and troubleshoot towards course completion. Participants will also be able to send text messages to coaches. Receives: Other: Digital Training with Coaching (DT-C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge quiz
The primary outcome is a knowledge-based competency measure that incorporates an 17-item multiple-choice quiz (MCQ), with questions related to case-based vignettes that will be administered through the REDCap platform. Parallel forms of the quiz will be used at baseline and endline assessments, the sequencing of which will be determined at random. The assessment format and topic domains have been informed by previous research on competency assessments for nonspecialists (Asher et al., 2021; Ottman, Kohrt, Pedersen \& Schafer, 2020; Pedersen et al., 2021; Kohrt et al. 2015a; Kohrt et al. 2015b, Kohrt et al. 2020). The measure includes questions related to psychotherapies generally as well as specific problem-solving competencies.). Prior to unblinding the dataset, we will carry out a psychometric analysis of MCQ item scores across the entire sample. Poorly performing items may be removed and the primary outcome analysis will be conducted using retained items.
Measured: Change from Baseline Knowledge-based Competency at 6 weeks post randomisation
Secondary outcomes (1)
MUSIC
This will be assessed post-training only. We will use a 26-item questionnaire adapted from MUSIC (eMpowerment, Usefulness, Success, Interest, Caring), an established measure of satisfaction with educational programs that has previously been used in the study setting (Jones, 2017). Items on the questionnaire cover the feasibility, acceptability, adoption and appropriateness of the training program. These are rated on 6 point likert scale ranging from Strongly Agree to Strongly Disagree. The purpose is to identify strengths and weaknesses related to course content that may influence participants' engagement and thus to inform improvements.
Measured: 6 weeks post randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start6 Apr 2022
- Primary completion16 Aug 2022
- Study completion16 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Depression, AnxietyStudies 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
- Model description
- Interventional Study Model: Digital training intervention: delivered to all participants (pre-and-post comparison) Additional coaching intervention: two-arm, individually randomized controlled trial with parallel assignment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 277 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sangath
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM), London School of Hygiene and Tropical Medicine
- Responsible party
- Sponsor
- Investigators
- Vikram Patel, PhD, Principal investigator, Harvard Medical School (HMS and HSDM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05290142
- Sponsor's protocol ID
- VP_2015_017
- Other IDs
- 106919/Z/15/Z
- Status last verified
- May 2022
- First submitted
- 11 Mar 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan to Share IPD: Anonymised participant data, data dictionary and case report forms will be made available 12 months after study completion. Data will be shared after approval by the corresponding author, following a reasonable submitted request. The study protocol and statistical analysis plan are publicly available.
Publications
Michelson D, Malik K, Parikh R, Weiss HA, Doyle AM, Bhat B, Sahu R, Chilhate B, Mathur S, Krishna M, Sharma R, Sudhir P, King M, Cuijpers P, Chorpita B, Fairburn CG, Patel V. Effectiveness of a brief lay counsellor-delivered, problem-solving intervention for adolescent mental health problems in urban, low-income schools in India: a randomised controlled trial. Lancet Child Adolesc Health. 2020 Aug;4(8):571-582. doi: 10.1016/S2352-4642(20)30173-5. Epub 2020 Jun 23.
PubMed 32585185Asher L, Birhane R, Teferra S, Milkias B, Worku B, Habtamu A, Kohrt BA, Hanlon C. "Like a doctor, like a brother": Achieving competence amongst lay health workers delivering community-based rehabilitation for people with schizophrenia in Ethiopia. PLoS One. 2021 Feb 25;16(2):e0246158. doi: 10.1371/journal.pone.0246158. eCollection 2021.
PubMed 33630893Ottman KE, Kohrt BA, Pedersen GA, Schafer A. Use of role plays to assess therapist competency and its association with client outcomes in psychological interventions: A scoping review and competency research agenda. Behav Res Ther. 2020 Jul;130:103531. doi: 10.1016/j.brat.2019.103531. Epub 2019 Dec 14.
PubMed 31902517Pedersen, G. A., Gebrekristos, F., Eloul, L., Golden, S., Hemmo, M., Akhtar, A., ... & Kohrt, B. A. (2021). Development of a Tool to Assess Competencies of Problem Management Plus Facilitators Using Observed Standardised Role Plays: The EQUIP Competency Rating Scale for Problem Management Plus. Intervention, 19(1), 107.
Kohrt BA, Jordans MJ, Rai S, Shrestha P, Luitel NP, Ramaiya MK, Singla DR, Patel V. Therapist competence in global mental health: Development of the ENhancing Assessment of Common Therapeutic factors (ENACT) rating scale. Behav Res Ther. 2015 Jun;69:11-21. doi: 10.1016/j.brat.2015.03.009. Epub 2015 Mar 24.
PubMed 25847276Kohrt BA, Ramaiya MK, Rai S, Bhardwaj A, Jordans MJD. Development of a scoring system for non-specialist ratings of clinical competence in global mental health: a qualitative process evaluation of the Enhancing Assessment of Common Therapeutic Factors (ENACT) scale. Glob Ment Health (Camb). 2015;2:e23. doi: 10.1017/gmh.2015.21. Epub 2015 Dec 9.
PubMed 28593049Kohrt BA, Schafer A, Willhoite A, Van't Hof E, Pedersen GA, Watts S, Ottman K, Carswell K, van Ommeren M. Ensuring Quality in Psychological Support (WHO EQUIP): developing a competent global workforce. World Psychiatry. 2020 Feb;19(1):115-116. doi: 10.1002/wps.20704. No abstract available.
PubMed 31922690Jones, B. D., Li, M., & Cruz, J. M. (2017). A cross-cultural validation of the MUSIC® Model of Academic Motivation Inventory: Evidence from Chinese-and Spanish-speaking university students. International Journal of Educational Psychology, 6(1), 25-44.
Mathur S, Weiss HA, Neuman M, Field AP, Leurent B, Shetty T, J JE, Nair P, Mathews R, Malik K, Michelson D, Patel V. Coach-Supported Versus Self-guided Digital Training Course for a Problem-solving Psychological Intervention for Nonspecialists: Protocol for a Pre-Post Nested Randomized Controlled Trial. JMIR Res Protoc. 2023 Jun 13;12:e41981. doi: 10.2196/41981.
PubMed 37310781
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pre-and-post Study With a Nested Randomised Controlled Trial of Coach Versus Self-guided Digital Training in a Youth-focused Problem-solving Intervention
- ClinicalTrials.gov ID
- NCT05290142
- Acronym / sponsor ID
- VP_2015_017
- Conditions
- Depression, Anxiety
- Keywords
- digital training, mental health intervention, adolescent mental health, non-specialists
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 277 participants (actual)
- Lead sponsor
- SangathUniversity, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM), London School of Hygiene and Tropical Medicine
- Study start
- 6 Apr 2022 (actual)
- Primary completion
- 16 Aug 2022 (actual)
- Study completion
- 16 Aug 2022 (actual)
- First posted
- 22 Mar 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.
This study is part of a Wellcome Trust-funded research program in India called PRIDE (PRemIum for aDolEscents, 2016-2022) led by Principal Investigator Prof. Vikram Patel (Harvard Medical School). The goal of PRIDE is to establish a suite of scalable psychosocial interventions for common adolescent mental health problems in India.
Following on from earlier studies to develop and evaluate the various PRIDE interventions in school settings, the current study aims to generate evidence on methods to support implementation. We will undertake a pre-and-post study design with a nested randomized controlled trial with the specific aims to:
- Evaluate the effects of digital training on non-specialists' competency to deliver an evidence-based problem-solving intervention for common adolescent mental health problems
- Evaluate the incremental effect of digital training with coaching (DT-C) in comparison with self-guided digital training (DT) on non-specialists' competency to deliver an evidence-based problem-solving intervention for common adolescent mental health problems
- Evaluate the processes affecting the implementation of training interventions in both arms
Detailed description
PRIDE has been implemented in India to address the scarcity of evidence- based interventions for common adolescent mental health problems nationally and in low-resource settings more widely (Michelson et al., 2020). The goal is to develop and evaluate a suite of scalable, transdiagnostic psychological interventions (i.e., suitable for a variety of mental health presentations) that can be delivered by non-specialist ('lay') counsellors in resource-poor school settings.
There is a major knowledge gap concerning how to build capacity outside of specialist health settings and how to motivate and support non-specialists through structured capacity building activities in absence of adequate specialist trainers.
Hence, the aim of the current study is to evaluate the effectiveness of a digital training for non-specialists to improve their competency in delivering an evidence-based adolescent mental health intervention.
SIGNIFICANCE:
The health care system in India faces a number of key challenges: (1) poor quality and inadequately resourced primary health care; (2) low numbers and unequally distributed skilled human resources; (3) a large, unregulated, private sector; (4) low public spending on health leading to high levels of out of pocket expenditure; (5) fragmented health information systems; (6) irrational use and spiralling costs of drugs and technology; and (7) weak governance and accountability.
The current study will address the dearth of evidence on workforce development strategies necessary to scale-up evidence-based adolescent mental health interventions in low-resource settings.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Interventional Study Model: Digital training intervention: delivered to all participants (pre-and-post comparison) Additional coaching intervention: two-arm, individually randomized controlled trial with parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Self-Guided Digital Training (DT) | Active comparator | Other: Self-Guided Digital TrainingParticipants will be enrolled in a digital training course that addresses non-specific counselling skills and skills specific to an evidence-based problem-solving intervention. The course will be available online on a smartphone app as well as a website that can be accessed through an internet-enabled device. Participants will also have an option to message a centralized helpline for assistance with accessing and navigating the digital interface. |
| Digital Training with Coaching (DT-C) | Experimental | Other: Digital Training with Coaching (DT-C)In addition to receiving the same digital training resources as the DT group, participants in DT-C will receive weekly individualized telephone calls from a coach who will motivate them and troubleshoot towards course completion. Participants will also be able to send text messages to coaches. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or above
- Associated with one of the partner organizations/institutes
- Access to an internet-enabled smartphone or computer device
- Provides consent to participate
Key exclusion criteria (1 listed)
- Prior practice-based education and/or training in psychotherapy or mental health interventions.
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 |
|---|---|---|
| Digital Training with Coaching (DT-C)An identical digital training course and helpline will be available for the participants in this group. In addition to receiving the same digital training resources as the DT group, participants in DT-C will receive weekly individualized telephone calls from a coach who will motivate them and troubleshoot towards course completion. The focus will be on clarifying learning objectives and redirecting participants to relevant materials rather than providing new learning opportunities. Participants will also be able to send text messages to coaches with queries related to course content, progress and technical difficulties. Coaches will reply to participants' messages within one working day and send reminders about upcoming telephone sessions, as well as prompts if the participant has not logged into the course for 3 consecutive days. | Other | Digital Training with Coaching (DT-C) |
| Self-Guided Digital TrainingParticipants will be enrolled in a digital training course that addresses non-specific counselling skills and skills specific to an evidence-based problem-solving intervention. The course will be available offline and online on a smartphone app (called 'Sangath Training') as well as a website (https://training.sangath.in/login/index.php) that can be accessed through an internet-enabled device. The training will be delivered through didactic lectures, role-play demonstrations, and recommended readings spread across 16 modules. Participants will be provided with automated feedback on their learning through self-assessment quizzes after each module. Modules will be available sequentially and unlocked after accessing all content in the preceding module, over a period of 4 weeks. Technical helpline: Participants will also have an option to message a centralized helpline for assistance with accessing and navigating the digital interface. | Other | Self-Guided Digital Training (DT) |
Primary outcome
Knowledge quiz
Time frame: Change from Baseline Knowledge-based Competency at 6 weeks post randomisation
The primary outcome is a knowledge-based competency measure that incorporates an 17-item multiple-choice quiz (MCQ), with questions related to case-based vignettes that will be administered through the REDCap platform. Parallel forms of the quiz will be used at baseline and endline assessments, the sequencing of which will be determined at random. The assessment format and topic domains have been informed by previous research on competency assessments for nonspecialists (Asher et al., 2021; Ottman, Kohrt, Pedersen \& Schafer, 2020; Pedersen et al., 2021; Kohrt et al. 2015a; Kohrt et al. 2015b, Kohrt et al. 2020). The measure includes questions related to psychotherapies generally as well as specific problem-solving competencies.). Prior to unblinding the dataset, we will carry out a psychometric analysis of MCQ item scores across the entire sample. Poorly performing items may be removed and the primary outcome analysis will be conducted using retained items.
1 secondary outcome
MUSIC
Time frame: 6 weeks post randomisation
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 8 Nov 2022.
- Background: PubMed 32585185Michelson D, Malik K, Parikh R, Weiss HA, Doyle AM, Bhat B, Sahu R, Chilhate B, Mathur S, Krishna M, Sharma R, Sudhir P, King M, Cuijpers P, Chorpita B, Fairburn CG, Patel V. Effectiveness of a brief lay counsellor-delivered, problem-solving intervention for adolescent mental health problems in urban, low-income schools in India: a randomised controlled trial. Lancet Child Adolesc Health. 2020 Aug;4(8):571-582. doi: 10.1016/S2352-4642(20)30173-5. Epub 2020 Jun 23.
- Background: PubMed 33630893Asher L, Birhane R, Teferra S, Milkias B, Worku B, Habtamu A, Kohrt BA, Hanlon C. "Like a doctor, like a brother": Achieving competence amongst lay health workers delivering community-based rehabilitation for people with schizophrenia in Ethiopia. PLoS One. 2021 Feb 25;16(2):e0246158. doi: 10.1371/journal.pone.0246158. eCollection 2021.
- Background: PubMed 31902517Ottman KE, Kohrt BA, Pedersen GA, Schafer A. Use of role plays to assess therapist competency and its association with client outcomes in psychological interventions: A scoping review and competency research agenda. Behav Res Ther. 2020 Jul;130:103531. doi: 10.1016/j.brat.2019.103531. Epub 2019 Dec 14.
- BackgroundPedersen, G. A., Gebrekristos, F., Eloul, L., Golden, S., Hemmo, M., Akhtar, A., ... & Kohrt, B. A. (2021). Development of a Tool to Assess Competencies of Problem Management Plus Facilitators Using Observed Standardised Role Plays: The EQUIP Competency Rating Scale for Problem Management Plus. Intervention, 19(1), 107.
- Background: PubMed 25847276Kohrt BA, Jordans MJ, Rai S, Shrestha P, Luitel NP, Ramaiya MK, Singla DR, Patel V. Therapist competence in global mental health: Development of the ENhancing Assessment of Common Therapeutic factors (ENACT) rating scale. Behav Res Ther. 2015 Jun;69:11-21. doi: 10.1016/j.brat.2015.03.009. Epub 2015 Mar 24.
- Background: PubMed 28593049Kohrt BA, Ramaiya MK, Rai S, Bhardwaj A, Jordans MJD. Development of a scoring system for non-specialist ratings of clinical competence in global mental health: a qualitative process evaluation of the Enhancing Assessment of Common Therapeutic Factors (ENACT) scale. Glob Ment Health (Camb). 2015;2:e23. doi: 10.1017/gmh.2015.21. Epub 2015 Dec 9.
- Background: PubMed 31922690Kohrt BA, Schafer A, Willhoite A, Van't Hof E, Pedersen GA, Watts S, Ottman K, Carswell K, van Ommeren M. Ensuring Quality in Psychological Support (WHO EQUIP): developing a competent global workforce. World Psychiatry. 2020 Feb;19(1):115-116. doi: 10.1002/wps.20704. No abstract available.
- BackgroundJones, B. D., Li, M., & Cruz, J. M. (2017). A cross-cultural validation of the MUSIC® Model of Academic Motivation Inventory: Evidence from Chinese-and Spanish-speaking university students. International Journal of Educational Psychology, 6(1), 25-44.
- Derived from this study: PubMed 37310781Mathur S, Weiss HA, Neuman M, Field AP, Leurent B, Shetty T, J JE, Nair P, Mathews R, Malik K, Michelson D, Patel V. Coach-Supported Versus Self-guided Digital Training Course for a Problem-solving Psychological Intervention for Nonspecialists: Protocol for a Pre-Post Nested Randomized Controlled Trial. JMIR Res Protoc. 2023 Jun 13;12:e41981. doi: 10.2196/41981.
- Individual participant dataSharing planned: Yes. Plan to Share IPD: Anonymised participant data, data dictionary and case report forms will be made available 12 months after study completion. Data will be shared after approval by the corresponding author, following a reasonable submitted request. The study protocol and statistical analysis plan are publicly available.
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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.
Vikram Patel, PhD principal investigator
Harvard Medical School (HMS and HSDM)
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Training with Coaching (DT-C) and Self-Guided Digital Training in people with Depression, Anxiety, run by Sangath at 9 sites in India.
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 4 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: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in India. 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?
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?
Knowledge quiz (time frame: Change from Baseline Knowledge-based Competency at 6 weeks post randomisation). 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 NCT05290142, which also lists 9 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 8 Nov 2022.