DepressionEQUIP-PM+NCT04954872
Competency-based Training in Problem Management Plus: a Randomized Controlled Trial
A study testing Standard Problem Management Plus training (training as usual) and Equip-based Problem Management Plus training in people with Depression, run by George Washington University at 1 site in Nepal.
Trial summary
The proposed study in Nepal will evaluate if non-specialists participating in Equip-based Problem Management Plus training show greater competencies compared to non-specialists participating in standard Problem Management Plus training. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Standard Problem Management Plus training (training as usual) and Equip-based Problem Management Plus training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteNepal
- Study dates
- 1 Jun 2021to 31 Dec 2021
- 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
- No prior mental health professional training
- Literate in Nepali
Who cannot join
- Any prior mental health professional training
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Strategies for Competency-based Training in Problem Management Plus to Improve Non-specialist Competencies for Responding to Psychological Distress: a Randomized Controlled Trial
The proposed study in Nepal will evaluate if non-specialists participating in Equip-based Problem Management Plus training show greater competencies compared to non-specialists participating in standard Problem Management Plus training. The proposed study is a randomized controlled trial with mixed-methods components evaluating both quantitative outcomes and qualitative outcomes among non-specialists participating in the training and their trainers.
Read the detailed description
There is increasing recognition of the high burden of psychological distress among populations around the world. Increasingly, non-specialists (persons who do not have expertise in formal mental health training) are being used to deliver psychological services. There is a long history of successful implementation of psychological services by non-specialists in Nepal. Recently, a cluster randomized controlled trial of Problem Management Plus showed modest benefit over enhanced care as usual in southeastern Nepal. A recent initiative by the World Health Organization is being rolled out to improve the competencies of non-specialists participating in Problem Management Plus and similar trainings. This initiative is Ensuring Quality in Psychological Services (Equip). The proposed study in Nepal will evaluate if non-specialists participating in Equip-based Problem Management Plus training show greater competencies compared to non-specialists participating in standard Problem Management Plus training. The proposed study is a randomized controlled trial with mixed-methods components evaluating both quantitative outcomes and qualitative outcomes among non-specialists participating in the training and their trainers.
- Conditions
- Depression
- Being tested
- Standard Problem Management Plus training (training as usual), Equip-based Problem Management Plus training
- Keywords
- Training, Competency, Psychological treatment
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Problem Management Plus training (training as usual)Behavioural
10-day training on Problem Management Plus.
Equip-based Problem Management Plus trainingBehavioural
Training and supervision for Problem Management Plus in which the trainers and supervisors use the EQUIP platform for competency assessment and feedback.
| Study group | Role | What they receive |
|---|---|---|
| Training as usual | Active comparator | Standard Problem Management Plus training. Receives: Behavioral: Standard Problem Management Plus training (training as usual) |
| Equip-based training | Experimental | Training that uses the Equip platform to assess competencies and incorporate this information into trainers and supervisors activities. Receives: Behavioral: Equip-based Problem Management Plus training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enhancing Assessment of Common Therapeutic Factors (unabbreviated title: Enhancing Assessment of Common Therapeutic Factors)
15-item tool with 4 response levels, range is 15 to 60, with higher scores equating to more competency
Measured: Immediately after Problem Management Plus training (10-days post-baseline)
Secondary outcomes (5)
Enhancing Assessment of Common Therapeutic Factors (unabbreviated title: Enhancing Assessment of Common Therapeutic Factors)
15-item tool with 4 response levels, range is 15 to 60, with higher scores equating to more competency
Measured: After Problem Management Plus supervision (approximately 45-days post-baseline)
Problem Management Plus Competency Assessment (unabbreviated title: Problem Management Plus Competency Assessment)
12-item tool with 4 response levels, range is 12 to 48, with higher scores equating to more competency
Measured: Immediately after Problem Management Plus training (10-days post-baseline)
Problem Management Plus Competency Assessment (unabbreviated title: Problem Management Plus Competency Assessment)
12-item tool with 4 response levels, range is 12 to 48, with higher scores equating to more competency
Measured: After Problem Management Plus supervision (approximately 45-days post-baseline)
Group Facilitation Competency Assessment (unabbreviated title: Group Facilitation Competency Assessment)
8-item tool with 4 response levels, range is 8 to 32, with higher scores equating to more competency
Measured: Immediately after Problem Management Plus training (10-days post-baseline)
Group Facilitation Competency Assessment (unabbreviated title: Group Facilitation Competency Assessment)
8-item tool with 4 response levels, range is 8 to 32, with higher scores equating to more competency
Measured: After Problem Management Plus supervision (approximately 45-days post-baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start1 Jun 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Persons without mental health professional experience will be randomized to either training as usual to develop Problem Management Plus competencies or they will be randomized to Problem Management Plus training that uses Equip principles of competency-based training.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Collaborators
- Transcultural Psychosocial Organization Nepal
- Responsible party
- Principal investigator, Brandon A Kohrt, MD, PhD, George Washington University
- Investigators
- Brandon A Kohrt, MD, PhD, Principal investigator, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04954872
- Sponsor's protocol ID
- NCR191797-v2
- Acronym
- EQUIP-PM+
- Status last verified
- Sep 2022
- First submitted
- 29 Jun 2021
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Researchers can contact the principal investigator for access to data.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Strategies for Competency-based Training in Problem Management Plus to Improve Non-specialist Competencies for Responding to Psychological Distress: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04954872
- Acronym / sponsor ID
- EQUIP-PM+ / NCR191797-v2
- Conditions
- Depression
- Keywords
- Training, Competency, Psychological treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Collaborators
- Transcultural Psychosocial Organization Nepal
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 8 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study in Nepal will evaluate if non-specialists participating in Equip-based Problem Management Plus training show greater competencies compared to non-specialists participating in standard Problem Management Plus training. The proposed study is a randomized controlled trial with mixed-methods components evaluating both quantitative outcomes and qualitative outcomes among non-specialists participating in the training and their trainers.
Detailed description
There is increasing recognition of the high burden of psychological distress among populations around the world. Increasingly, non-specialists (persons who do not have expertise in formal mental health training) are being used to deliver psychological services. There is a long history of successful implementation of psychological services by non-specialists in Nepal. Recently, a cluster randomized controlled trial of Problem Management Plus showed modest benefit over enhanced care as usual in southeastern Nepal. A recent initiative by the World Health Organization is being rolled out to improve the competencies of non-specialists participating in Problem Management Plus and similar trainings. This initiative is Ensuring Quality in Psychological Services (Equip). The proposed study in Nepal will evaluate if non-specialists participating in Equip-based Problem Management Plus training show greater competencies compared to non-specialists participating in standard Problem Management Plus training. The proposed study is a randomized controlled trial with mixed-methods components evaluating both quantitative outcomes and qualitative outcomes among non-specialists participating in the training and their trainers.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Persons without mental health professional experience will be randomized to either training as usual to develop Problem Management Plus competencies or they will be randomized to Problem Management Plus training that uses Equip principles of competency-based training.
| Arm | Type | Receives |
|---|---|---|
| Training as usual | Active comparator | Behavioral: Standard Problem Management Plus training (training as usual)Standard Problem Management Plus training. |
| Equip-based training | Experimental | Behavioral: Equip-based Problem Management Plus trainingTraining that uses the Equip platform to assess competencies and incorporate this information into trainers and supervisors activities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- No prior mental health professional training
- Literate in Nepali
Key exclusion criteria (1 listed)
- Any prior mental health professional training
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 |
|---|---|---|
| Standard Problem Management Plus training (training as usual)10-day training on Problem Management Plus. | Behavioural | Training as usual |
| Equip-based Problem Management Plus trainingTraining and supervision for Problem Management Plus in which the trainers and supervisors use the EQUIP platform for competency assessment and feedback. | Behavioural | Equip-based training |
Primary outcome
Enhancing Assessment of Common Therapeutic Factors (unabbreviated title: Enhancing Assessment of Common Therapeutic Factors)
Time frame: Immediately after Problem Management Plus training (10-days post-baseline)
15-item tool with 4 response levels, range is 15 to 60, with higher scores equating to more competency
5 secondary outcomes
Enhancing Assessment of Common Therapeutic Factors (unabbreviated title: Enhancing Assessment of Common Therapeutic Factors)
Time frame: After Problem Management Plus supervision (approximately 45-days post-baseline)
Problem Management Plus Competency Assessment (unabbreviated title: Problem Management Plus Competency Assessment)
Time frame: Immediately after Problem Management Plus training (10-days post-baseline)
Problem Management Plus Competency Assessment (unabbreviated title: Problem Management Plus Competency Assessment)
Time frame: After Problem Management Plus supervision (approximately 45-days post-baseline)
Group Facilitation Competency Assessment (unabbreviated title: Group Facilitation Competency Assessment)
Time frame: Immediately after Problem Management Plus training (10-days post-baseline)
Group Facilitation Competency Assessment (unabbreviated title: Group Facilitation Competency Assessment)
Time frame: After Problem Management Plus supervision (approximately 45-days post-baseline)
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 29 Sep 2022.
- Individual participant dataSharing planned: Yes. Researchers can contact the principal investigator for access to data.
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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.
Brandon A Kohrt, MD, PhD principal investigator
George Washington University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Problem Management Plus training (training as usual) and Equip-based Problem Management Plus training in people with Depression, run by George Washington University 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 2 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 29 Sep 2022. 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?
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?
Enhancing Assessment of Common Therapeutic Factors (unabbreviated title: Enhancing Assessment of Common Therapeutic Factors) (time frame: Immediately after Problem Management Plus training (10-days post-baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2022.