Psychological DistressEQUIPNCT04704362
Ensuring Quality in Psychological Support
A study testing Ensuring Quality in Psychological Support and Standard Training and Supervision in people with Psychological Distress and Depression, run by George Washington University at 7 sites in 7 countries.
Trial summary
The goal of this project is to test tools that will be part of a platform for training and supervision of mental health and psychosocial support helpers, including providers without specialized training in mental health. Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychological Distress, Depression
- What is being tested?
- Ensuring Quality in Psychological Support and Standard Training and Supervision
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 896 participants
- Where
- 7 sitesin 7 countries
- Study dates
- 20 Jun 2020to 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 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Trainees: Non-specialist in mental health and psychosocial support
- Clients: Site-specific level of distress to determine psychological intervention participation
Who cannot join
- Trainees: Unable to comprehend language that training and supervision will be conducted in
- Clients: Serious mental illness, developmental disability
Trial locations and contacts
7 sites in 7 countries.
7 sites in 7 countries
About this study
The goal of this project is to test tools that will be part of a platform for training and supervision of mental health and psychosocial support helpers, including providers without specialized training in mental health. This platform, entitled Ensuring Quality in Psychological Support, is an online resource being developed to include: materials for evaluating core and specific competencies, training on core competencies, implementation guidance to conduct competency-based training. The Ensuring Quality in Psychological Support platform is designed to aid trainers and supervisors working with providers being trained to deliver World Health Organization and non-World Health Organization low-intensity psychological interventions. The research will address two study objectives: Objective 1. Determine feasibility, acceptability, and perceived utility of the Ensuring Quality in Psychological Support platform; Objective 2. Evaluate the reliability, validity, and sensitivity to change of Ensuring Quality in Psychological Support competency assessment tools. To maximize generalizability of findings, Ensuring Quality in Psychological Support will be evaluated in seven countries: Ethiopia, Kenya, Lebanon, Peru, Uganda, Zambia and Jordan. The sites are varied by types of psychological intervention, beneficiaries, experience of trainers, and background of trainees. In each site, trainers will train non-specialist providers on a low-intensity psychological intervention.
Read the detailed description
There is increasing evidence that non-specialist or minimally trained mental health providers can effectively provide support and deliver psychosocial support and low-intensity psychological interventions for common mental disorders and substance use disorders in low resource settings. Psychological treatments delivered by non-specialists in low-resource settings have effectiveness comparable to high-income country studies of specialist interventions.
Low intensity interventions refer to interventions that do not rely on specialists and are modified, brief evidence-based therapies including guide self-help and e-mental health. The World Health Organization identifies such interventions as being: brief, basic, non-specialist-delivered versions of existing evidence-based psychological treatments (e.g., basic versions of cognitive-behavioral therapy, interpersonal therapy); and may include self-help materials (e.g., self-help books, audiovisual materials, and online or app-based self-help interventions); individual or group programs, and designed to be age-appropriate (i.e., delivered differently for children and adults). Moreover, low intensity interventions are particularly well suited to communities affected by adversity, as they use fewer resources which make them more scalable.
Psychosocial refers to interventions that are designed to address the psychological effects of conflict [or adversity], including the effects on behavior, emotion, thoughts, memory and functioning, and social effects, including changes in relationships, social support and economic status. The term psychosocial emphasizes, the close connection between psychological aspects of experience and wider social aspects of experience, inclusive of human capacity, social ecology, and culture and values. For the purpose of this study, low intensity psychological and psychosocial interventions were selected using the criteria above, and ensuring the interventions are freely accessible to the public.
To assure success of such interventions outside the context of resource-intensive research trials, it is crucial to develop training and supervision programs that produce competent providers of psychological and psychosocial support interventions. A necessary element to achieve this goal is development of standardized tools and procedures to assess the competency of those trained to deliver them; while ensuring competency assessment results are easily understandable to trainers and supervisors so that they can remediate areas of low competency.
In the context of psychological and psychosocial interventions, competency refers the extent to which a therapist [including non-specialists] has the knowledge and skill required to deliver a treatment to the standard needed for it to achieve its expected effects. Competency is typically assessed through structured role-plays in which trained standardized [mock] clients elicit trainee's ability to perform the key skills of an intervention. Role-plays such as this are commonly used in health professional training and evaluation in the form of observed structured clinical evaluations with simulated patients. The Ensuring Quality in Psychological Support initiative was developed out of need to have easily implementable competency evaluation tools and remediation training materials that can be used with specialists and non-specialists in diverse global settings. To supplement the platform, Ensuring Quality in Psychological Support will also include various implementation, trainer and training resources and guidance.
The need for these competency assessment tools and training materials was identified in May 2018, during a Theory of Change Workshop conducted by the World Health Organization Ensuring Quality in Psychological Support team with frontline psychological service practitioners, clinicians, non-governmental organization training and supervision staff, and researchers. The four key elements of the platform will be (a) competency tools for evaluation of non-specific (core competencies or common factors) and specific practice elements (or treatment specific factors); (b) role-play vignettes for conducting competency evaluations; (c) instructional materials on how to conduct competency evaluations (training standardized clients, establishing inter-rater reliability when conducting competency evaluations, using rating tools, interpreting results); and (d) instructional materials on how to integrate competency evaluations into trainings and supervision (giving feedback to participants, modifying training programs, feedback to trainers and supervisors) including core competency training and remediation materials.
Study Goals and Objectives:
The goal of the study is to inform development of the Ensuring Quality in Psychological Support platform and its tools, ensuring feasibility, acceptability, utility, reliability, and validity to support the provision of quality psychological support.
Study Objectives
- Determine the feasibility, acceptability, and perceived utility, of the Ensuring Quality in Psychological Support platform to facilitate assessment of competency and employ competency assessment results and remediation training materials to support training and supervision of non-specialists on low-intensity psychological interventions.
- Evaluate the reliability, validity, and sensitivity to change of Ensuring Quality in Psychological Support competency assessment tools based on inter-rater reliability of the tools within and between sites, ability to detect changes in competency over the course of training and supervision, and association with trainer ratings, as well as service delivery metrics and client outcomes across different psychological interventions and implementation sites.
- Conditions
- Psychological Distress, Depression
- Being tested
- Ensuring Quality in Psychological Support, Standard Training and Supervision
- Keywords
- Training, Competency, Mental health, Psychological treatment
- Medical subject headings
- Depression, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ensuring Quality in Psychological SupportBehavioural
Trainees are evaluated with the Enhancing Assessment of Common Therapeutic factors structured role play tool and the results are shared with trainers and/or supervisors to modify training based on strengths and weakness on the competency scores.
Standard Training and SupervisionBehavioural
Trainees are trained using a manual for non-specialist-delivered psychological interventions.
| Study group | Role | What they receive |
|---|---|---|
| Training and Supervision as Usual | Active comparator | Non-specialists are trained in a psychological intervention under standard conditions. No feedback from competency-based evaluations is provided to modify the training or supervision curriculum. Receives: Behavioral: Standard Training and Supervision |
| Competency-based Training and Supervision | Experimental | Non-specialists are trained and supervised in a competency-based approach in which trainers and/or supervisors are provided with the competency scores of trainees in order to modify the training and supervision content and approach as needed. Receives: Behavioral: Ensuring Quality in Psychological Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trainee - Enhancing Assessment of Common Therapeutic factors; Unabbreviated scale title: "Enhancing Assessment of Common Therapeutic Factors"
15-item objective structured clinical examination using a role play, minimum value = 15, maximum value = 60, higher score means greater competency
Measured: Post-intensive supervision (approximately 1 month post-training)
Secondary outcomes (7)
Trainee - Enhancing Assessment of Common Therapeutic factors; Unabbreviated scale title: "Enhancing Assessment of Common Therapeutic Factors"
15-item objective structured clinical examination using a role play, minimum value = 15, maximum value = 60, higher score means greater competency
Measured: immediately after the manualized psychological treatment training
Trainee - Trainer Subjective Rating of Competency; unabbrievated scale title "Trainer Subjective Rating of Competency"
Trainer's subjective competency rating of trainee on a scale from 1 to 4, with higher scores reflecting greater competency.
Measured: immediately after the manualized psychological treatment training
Trainer's subjective competency rating of trainee on a scale from 1 to 4, with higher scores reflecting greater competency.
Trainer's subjective competency rating of trainee on a scale from 1 to 4, with higher scores reflecting greater competency.
Measured: Post-intensive supervision (approximately 1 month post-training)
Trainee - Equip-Treatment-specific competencies; unabbreviated title "Ensuring Quality in Psychological Support Treatment Specific Competency"
Site specific measure of trainee's competencies in manualized psychological intervention delivered by non-specialists; mean scores range from 1=potentially harmful, 2=some basic skills; 3=all basic skills; 4=advanced skills; higher score is more competency
Measured: Immediate post-training (last day of training on manualized intervention)
Trainee - Equip-Treatment-specific competencies; unabbreviated title "Ensuring Quality in Psychological Support Treatment Specific Competency"
Site specific measure of trainee's competencies in manualized psychological intervention delivered by non-specialists; mean scores range from 1=potentially harmful, 2=some basic skills; 3=all basic skills; 4=advanced skills; higher score is more competency
Measured: Post-intensive supervision (approximately 1 month post-training)
Client - mental health outcome, for example, Patient Health Questionnaire; unabbreviated title "Patient Health Questionnaire"
Site specific mental health outcome measure of client; higher scores reflect greater psychological distress; for example, Patient Health questionnaire range from 0 to 27; greater score is more symptoms.
Measured: Immediately after completion of the manualized psychological treatment
Client - functioning outcome, for example, unabbreviated title: "World Health Organization Disability Assessment Schedule"
Site specific client functional impairment measure; higher scores reflect greater functional impairment; for example, World Health Organization Disability Assessment Schedule score range from 0 to 60; greater score is more impairment.
Measured: Immediately after completion of the manualized psychological treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start20 Jun 2020
- 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 Psychological DistressStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a non-randomized controlled trial comparing training and supervision as usual with training and supervision using a competency-based approach.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 896 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization, The Center for Victims of Torture, United States, University of Washington, University of Nairobi, War Child Holland, Socios En Salud Sucursal, Peru, University of South Florida, HealthRight International, Johns Hopkins University, Centre for Infectious Disease Research in Zambia, The University of New South Wales
- Responsible party
- Principal investigator, Brandon A Kohrt, MD, PhD, George Washington University
- Investigators
- Alison Schafer, PhD, Principal investigator, World Health Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04704362
- Sponsor's protocol ID
- NCR191797
- Acronym
- EQUIP
- Status last verified
- Sep 2022
- First submitted
- 29 Jul 2020
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be shared after completion of primary outcome publications from all sites.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ensuring Quality in Psychological Support
- ClinicalTrials.gov ID
- NCT04704362
- Acronym / sponsor ID
- EQUIP / NCR191797
- Conditions
- Psychological Distress, Depression
- Keywords
- Training, Competency, Mental health, Psychological treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 896 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Collaborators
- World Health Organization, The Center for Victims of Torture, United States, University of Washington, University of Nairobi, War Child Holland, Socios En Salud Sucursal, Peru, University of South Florida, HealthRight International, Johns Hopkins University, Centre for Infectious Disease Research in Zambia, The University of New South Wales
- Study start
- 20 Jun 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 11 Jan 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 goal of this project is to test tools that will be part of a platform for training and supervision of mental health and psychosocial support helpers, including providers without specialized training in mental health. This platform, entitled Ensuring Quality in Psychological Support, is an online resource being developed to include: materials for evaluating core and specific competencies, training on core competencies, implementation guidance to conduct competency-based training. The Ensuring Quality in Psychological Support platform is designed to aid trainers and supervisors working with providers being trained to deliver World Health Organization and non-World Health Organization low-intensity psychological interventions. The research will address two study objectives: Objective 1. Determine feasibility, acceptability, and perceived utility of the Ensuring Quality in Psychological Support platform; Objective 2. Evaluate the reliability, validity, and sensitivity to change of Ensuring Quality in Psychological Support competency assessment tools. To maximize generalizability of findings, Ensuring Quality in Psychological Support will be evaluated in seven countries: Ethiopia, Kenya, Lebanon, Peru, Uganda, Zambia and Jordan. The sites are varied by types of psychological intervention, beneficiaries, experience of trainers, and background of trainees. In each site, trainers will train non-specialist providers on a low-intensity psychological intervention.
Detailed description
There is increasing evidence that non-specialist or minimally trained mental health providers can effectively provide support and deliver psychosocial support and low-intensity psychological interventions for common mental disorders and substance use disorders in low resource settings. Psychological treatments delivered by non-specialists in low-resource settings have effectiveness comparable to high-income country studies of specialist interventions.
Low intensity interventions refer to interventions that do not rely on specialists and are modified, brief evidence-based therapies including guide self-help and e-mental health. The World Health Organization identifies such interventions as being: brief, basic, non-specialist-delivered versions of existing evidence-based psychological treatments (e.g., basic versions of cognitive-behavioral therapy, interpersonal therapy); and may include self-help materials (e.g., self-help books, audiovisual materials, and online or app-based self-help interventions); individual or group programs, and designed to be age-appropriate (i.e., delivered differently for children and adults). Moreover, low intensity interventions are particularly well suited to communities affected by adversity, as they use fewer resources which make them more scalable.
Psychosocial refers to interventions that are designed to address the psychological effects of conflict [or adversity], including the effects on behavior, emotion, thoughts, memory and functioning, and social effects, including changes in relationships, social support and economic status. The term psychosocial emphasizes, the close connection between psychological aspects of experience and wider social aspects of experience, inclusive of human capacity, social ecology, and culture and values. For the purpose of this study, low intensity psychological and psychosocial interventions were selected using the criteria above, and ensuring the interventions are freely accessible to the public.
To assure success of such interventions outside the context of resource-intensive research trials, it is crucial to develop training and supervision programs that produce competent providers of psychological and psychosocial support interventions. A necessary element to achieve this goal is development of standardized tools and procedures to assess the competency of those trained to deliver them; while ensuring competency assessment results are easily understandable to trainers and supervisors so that they can remediate areas of low competency.
In the context of psychological and psychosocial interventions, competency refers the extent to which a therapist [including non-specialists] has the knowledge and skill required to deliver a treatment to the standard needed for it to achieve its expected effects. Competency is typically assessed through structured role-plays in which trained standardized [mock] clients elicit trainee's ability to perform the key skills of an intervention. Role-plays such as this are commonly used in health professional training and evaluation in the form of observed structured clinical evaluations with simulated patients. The Ensuring Quality in Psychological Support initiative was developed out of need to have easily implementable competency evaluation tools and remediation training materials that can be used with specialists and non-specialists in diverse global settings. To supplement the platform, Ensuring Quality in Psychological Support will also include various implementation, trainer and training resources and guidance.
The need for these competency assessment tools and training materials was identified in May 2018, during a Theory of Change Workshop conducted by the World Health Organization Ensuring Quality in Psychological Support team with frontline psychological service practitioners, clinicians, non-governmental organization training and supervision staff, and researchers. The four key elements of the platform will be (a) competency tools for evaluation of non-specific (core competencies or common factors) and specific practice elements (or treatment specific factors); (b) role-play vignettes for conducting competency evaluations; (c) instructional materials on how to conduct competency evaluations (training standardized clients, establishing inter-rater reliability when conducting competency evaluations, using rating tools, interpreting results); and (d) instructional materials on how to integrate competency evaluations into trainings and supervision (giving feedback to participants, modifying training programs, feedback to trainers and supervisors) including core competency training and remediation materials.
Study Goals and Objectives:
The goal of the study is to inform development of the Ensuring Quality in Psychological Support platform and its tools, ensuring feasibility, acceptability, utility, reliability, and validity to support the provision of quality psychological support.
Study Objectives
- Determine the feasibility, acceptability, and perceived utility, of the Ensuring Quality in Psychological Support platform to facilitate assessment of competency and employ competency assessment results and remediation training materials to support training and supervision of non-specialists on low-intensity psychological interventions.
- Evaluate the reliability, validity, and sensitivity to change of Ensuring Quality in Psychological Support competency assessment tools based on inter-rater reliability of the tools within and between sites, ability to detect changes in competency over the course of training and supervision, and association with trainer ratings, as well as service delivery metrics and client outcomes across different psychological interventions and implementation sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a non-randomized controlled trial comparing training and supervision as usual with training and supervision using a competency-based approach.
| Arm | Type | Receives |
|---|---|---|
| Training and Supervision as Usual | Active comparator | Behavioral: Standard Training and SupervisionNon-specialists are trained in a psychological intervention under standard conditions. No feedback from competency-based evaluations is provided to modify the training or supervision curriculum. |
| Competency-based Training and Supervision | Experimental | Behavioral: Ensuring Quality in Psychological SupportNon-specialists are trained and supervised in a competency-based approach in which trainers and/or supervisors are provided with the competency scores of trainees in order to modify the training and supervision content and approach as needed. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Trainees: Non-specialist in mental health and psychosocial support
- Clients: Site-specific level of distress to determine psychological intervention participation
Key exclusion criteria (2 listed)
- Trainees: Unable to comprehend language that training and supervision will be conducted in
- Clients: Serious mental illness, developmental disability
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 |
|---|---|---|
| Ensuring Quality in Psychological SupportTrainees are evaluated with the Enhancing Assessment of Common Therapeutic factors structured role play tool and the results are shared with trainers and/or supervisors to modify training based on strengths and weakness on the competency scores. | Behavioural | Competency-based Training and Supervision |
| Standard Training and SupervisionTrainees are trained using a manual for non-specialist-delivered psychological interventions. | Behavioural | Training and Supervision as Usual |
Primary outcome
Trainee - Enhancing Assessment of Common Therapeutic factors; Unabbreviated scale title: "Enhancing Assessment of Common Therapeutic Factors"
Time frame: Post-intensive supervision (approximately 1 month post-training)
15-item objective structured clinical examination using a role play, minimum value = 15, maximum value = 60, higher score means greater competency
7 secondary outcomes
Trainee - Enhancing Assessment of Common Therapeutic factors; Unabbreviated scale title: "Enhancing Assessment of Common Therapeutic Factors"
Time frame: immediately after the manualized psychological treatment training
Trainee - Trainer Subjective Rating of Competency; unabbrievated scale title "Trainer Subjective Rating of Competency"
Time frame: immediately after the manualized psychological treatment training
Trainer's subjective competency rating of trainee on a scale from 1 to 4, with higher scores reflecting greater competency.
Time frame: Post-intensive supervision (approximately 1 month post-training)
Trainee - Equip-Treatment-specific competencies; unabbreviated title "Ensuring Quality in Psychological Support Treatment Specific Competency"
Time frame: Immediate post-training (last day of training on manualized intervention)
Trainee - Equip-Treatment-specific competencies; unabbreviated title "Ensuring Quality in Psychological Support Treatment Specific Competency"
Time frame: Post-intensive supervision (approximately 1 month post-training)
Client - mental health outcome, for example, Patient Health Questionnaire; unabbreviated title "Patient Health Questionnaire"
Time frame: Immediately after completion of the manualized psychological treatment
Client - functioning outcome, for example, unabbreviated title: "World Health Organization Disability Assessment Schedule"
Time frame: Immediately after completion of the manualized psychological treatment
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 28 Sep 2022.
- Individual participant dataSharing planned: Yes. Individual participant data will be shared after completion of primary outcome publications from all sites.
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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.
Alison Schafer, PhD principal investigator
World Health Organization
7 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ensuring Quality in Psychological Support and Standard Training and Supervision in people with Psychological Distress and Depression, run by George Washington University at 7 sites in 7 countries.
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 2 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 28 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 7 sites in Ethiopia, Jordan, Kenya, Lebanon, Peru and 2 more countries. 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?
Trainee - Enhancing Assessment of Common Therapeutic factors; Unabbreviated scale title: "Enhancing Assessment of Common Therapeutic Factors" (time frame: Post-intensive supervision (approximately 1 month post-training)). 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 28 Sep 2022.