Education, MedicalNCT04619615
Increasing Access to Evidence-based Treatments for Depression
A study testing Asynchronous self-directed digital training and Synchronous large group online workshop in people with Education, Medical, run by Mount Sinai Hospital, Canada at 4 sites in Canada.
Trial summary
The goal of this single-blind, randomized controlled pilot study is to evaluate the acceptability and feasibility of an Interpersonal Psychotherapy (IPT) asynchronous self-directed digital training platform for psychiatry residents, as compared to synchronous large group online workshop teaching. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Education, Medical
- What is being tested?
- Asynchronous self-directed digital training and Synchronous large group online workshop
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 4 sitesCanada
- Study dates
- 27 Jul 2020to 30 Dec 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
- Mount Sinai Hospital (MSH), Sunnybrook Health Sciences Centre (SHSC), Women's College Hospital (WCH) and the Centre for Addition and Mental Health (CAMH) PGY2-5 psychiatry residents treating patients
- Able to participate in the asynchronous self-directed on-line/synchronous large group online workshop
- Ability to add 1-2 patients to their caseload and provide a minimum of 12 IPT sessions over 6 months.
- Adults (≥18 years)
- Experiencing clinically significant depressive symptoms (defined as a score of ≥10 on the Patient Health Questionnaire-9, PHQ-9, during eligibility screening).
- Able to commit to attending a minimum of 12 IPT sessions over 6 months
- Sufficient English and literacy levels to fill in self-report measures
Who cannot join
- Academic concerns as flagged by the University of Toronto General Psychiatry program as evidenced by a referral to the University of Toronto Psychiatry Resident Evaluation Subcommittee OR significant concerns regarding promotion or progression as flagged by the University of Toronto Psychiatry Post-graduate Competence Sub-committee (responsible for reviewing all resident files twice a year).
- Diagnosis of borderline personality disorder, or psychotic or manic symptoms
- Active alcohol or substance use disorder within the past 6 months, assessed by a score >1 on items "2" through "5" the Global Appraisal of Individual Needs-Short Screener (GAIN-SS).
- Self-harm and/or at high risk of suicide or suicidal behaviors, as assessed by a score of >1 on question 9 of the PHQ-9, followed by an assessment of active suicidal ideation on the Mini International Neuropsychiatric Interview (MINI), as confirmed by the site PI
- Severe symptoms of depression, defined as a score of ≥20 on the PHQ-9 during eligibility screening
- <6 months discharged from psychiatric in-patient unit
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
Women's College Hospital
Toronto, Ontario, M5S 1B2
The Centre for Addiction and Mental Health
Toronto, Ontario, M6J 1H4
About this study
Official title: Increasing Access to Evidence-based Treatments for Depression: The Development and Evaluation of a Digital Training Platform for Interpersonal Psychotherapy.
The goal of this single-blind, randomized controlled pilot study is to evaluate the acceptability and feasibility of an Interpersonal Psychotherapy (IPT) asynchronous self-directed digital training platform for psychiatry residents, as compared to synchronous large group online workshop teaching. This study has the potential to improve access to competency-based training and dissemination of IPT, impacting healthcare delivery with increasing access to this evidence-based psychological depression treatment.
Read the detailed description
Background/Rational
The COVID-19 pandemic is expected to have an unprecedented impact on the mental health and well-being of patients, healthcare workers and our society at large. Among these illnesses, depression is expected to be the most prevalent to emerge and is already the leading cause of disability worldwide; it affects up to 1.8 million Canadians. While physical distancing is required to curb the spread of COVID-19, it is well known that social isolation is a substantive risk factor of mental illness and suicide.
Effective treatments exist but as few as 20% of Canadians receive minimally-adequate treatment for depression. One effective treatment for depression includes Interpersonal Psychotherapy (IPT) which may be particularly relevant for the isolation and life changes brought on by the COVID-19 pandemic. IPT is recommended in key consensus guidelines from the World Health Organization and the Canadian Network for Mood and Anxiety Treatments. IPT is a brief, structured psychological treatment that has been shown to effectively reduce depressive symptoms and enhance remission rates for patients across the lifespan. IPT proposes that the key to reducing depression is to increase connection with social supports and help patients work through triggering interpersonal experiences of loss/grief, life changes/social role transitions, interpersonal sensitivity/loneliness, or relational conflicts/role disputes. We selected IPT for three reasons: i) its strong evidence base for effectiveness as an antidepressant treatment, comparable in efficacy to CBT, with fewer patients dropping out of treatments; ii) its effectiveness in treating depression among culturally diverse patients across the lifespan; and iii) its parsimonious approach that is easy to understand and implement. This is critical when training novice clinicians. The poor dissemination of effective psychological therapies such as IPT is partly due to the limited number of available mental health professionals who can train novice clinicians with high fidelity; and one key obstacle is how these individuals are trained. Prior to the COVID-19 pandemic, this typically involved a trainee attending an expert-led workshop and then practicing the treatment under the supervision of someone experienced in delivering that treatment. The recent development of digital training platforms in various psychological treatments has attempted to address this training gap. In addition, web-conferencing applications have opened the door for distance psychotherapy training and supervision.
Online training methods need to be developed and examined to address this significant bottleneck, particularly in light of the current COVID-19 pandemic where in-person trainings have stopped but the need for evidence-based psychotherapy grows. The current study aims to examine two online training methods with consenting psychiatry resident/trainee therapists: a) asynchronous self-directed training through a novel digital training course which they will complete on their own schedule; and b) synchronous large group workshop where residents will participate in a live training workshop at a specific time. Asynchronous training is a more cost-effective and scalable method of training which permits residents (and other trainees) to learn psychotherapy according to their preferred schedules. To date, several asynchronous IPT training courses have been developed, however none have been compared to synchronous large group online workshop. The current study will provide preliminary evidence to examine the acceptability and feasibility of both models among psychiatry residents at University of Toronto affiliated hospitals.
Purpose
The main purpose of the current study is to examine the acceptability and feasibility of a digital training platform for psychiatry residents in IPT for depression treatment.
Aim 1. What is the feasibility of an asynchronous self-directed online digital training platform? To assess feasibility, we will examine psychiatric resident recruitment, and participation (completion of the online modules and homework assignments) for the intervention condition vs control (synchronous large group online workshop).
Aim 2. What is the acceptability of the asynchronous self-directed online digital training process and platform? We will assess acceptability by conducting a process evaluation; this will take the form of semi-structured interviews with all residents in the intervention to explore experiences of learning through the asynchronous self-directed online curriculum and platform along with facilitators and barriers to attaining the learning objectives of achieving competency in delivering IPT.
Aim 3. Does the asynchronous self-directed online training platform demonstrate preliminary efficacy when training PGY 2-5 psychiatry residents in IPT for depressed patients, as compared to a synchronous large group online workshop? This will be estimated by assessing changes in patient outcomes of depressive symptoms over the course of treatment. A secondary patient outcome will be changes in patient anxiety symptoms over the course of IPT treatment. In addition, therapist-related outcomes will be assessed including therapeutic alliance, therapy quality as assessed by IPT- specific skills and non-specific therapeutic communication skills, IPT-knowledge, and counseling self-efficacy.
Target Population
The target population are psychiatry residents in good standing with the University of Toronto (UofT), Faculty of Medicine, post-graduate psychiatry residency program, all of whom require training in IPT as part of the residency requirements, and their IPT patients. Specifically, this will include psychiatry residents from four UofT-affiliated hospitals, Mount Sinai Hospital (MSH), Women's College Hospital (WCH), Sunnybrook Health Sciences Centre (SHSC) and the Centre for Addition and Mental Health (CAMH).
Study Design
This is a mixed-methods feasibility and acceptability study, with a single blind randomized controlled design comparing asynchronous self-directed digital IPT training to a synchronous large group online IPT workshop. Patients will be blind to therapist study arm allocation.
Procedure
Residents doing clinical rotations at MSH, SHSC,WCH and CAMH as part of their Psychiatry Residency training at the University of Toronto will be approached for consent by the Research Coordinator (RC) at the beginning of each academic semester. Consenting resident participants will complete a measure of their counseling self-efficacy and IPT knowledge before randomization to the intervention or the control condition, stratified by study site (MSH, WCH, SHSC and CAMH). Patient recruitment will be through referrals via treatment providers at all study sites (MSH, SHSC, WCH, and CAMH). Patient participants will be stratified by site and then randomly assigned to residents in the intervention or control condition.
Resident participants will be randomized to one of two training conditions: (1) synchronous self-directed digital training (intervention condition), where residents will complete an interactive modular curriculum covering evidence-based psychotherapy principles and IPT-specific principles and strategies at their own pace over a two week time period; or (2) a synchronous online training workshop (control condition), which will involve the same content contained in the asynchronous self-directed digital training platform, except delivered over a one day online workshop.
Immediately after training has been completed, each resident participant will participate in structured role plays designed to assess the resident's competence on IPT-specific and general psychotherapy skills, as rated by two IPT experts. Resident participants will then begin their 12-week course of therapy with their assigned patient participant. During treatment delivery, residents will have once weekly one-on-one supervisory sessions with an IPT expert supervisor/faculty member of the University of Toronto, Department of Psychiatry, who will be blind to residents' foundational didactic training modality.
Patient participants will complete measures of their depressive and anxiety symptoms just before each weekly session, as well as a measure of therapeutic alliance at the 3rd and final therapy sessions. At every session resident participants will complete a measure of their impression of their patient's improvement (or lack thereof) as well as a measure of therapy quality. They will complete the measures of counseling self-efficacy and IPT knowledge at the conclusion of the course of therapy with their patient. Consenting resident-patient pairs will audio record each therapy session; these recordings will be transcribed and coded for therapy quality. Resident participants randomized to the intervention condition (asynchronous digital training) will complete a semi-structured interview exploring the barriers and facilitators to engaging with the digital training platform in order to assess the acceptability of the intervention.
- Conditions
- Education, Medical
- Being tested
- Asynchronous self-directed digital training, Synchronous large group online workshop
- Keywords
- Interpersonal Psychotherapy, Resident Education, Online Training, Depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asynchronous self-directed digital trainingOther
Resident participants will be able to complete the digital training at their own pace.
Synchronous large group online workshopOther
Resident participants will complete the digital training platform in real time over the course of a one day, live workshop (4.5 hours of online instruction).
| Study group | Role | What they receive |
|---|---|---|
| Asynchronous self-directed digital training | Experimental | A digital training program platform that delivers an interactive case-based modular curriculum covering evidence-based psychotherapy principles and IPT-specific principles and strategies with homework will take roughly 13 hours to complete, with 4.5 hours of online learning, and an additional 7.5 hours of reading and homework assignments. The reading and homework includes viewing captioned videotaped role plays and completing self-directed lesson plans. The digital curriculum leverages audio, video, and visual content, and is self-directed - for completion within a 2-week period. Residents can access this content through a smartphone, tablet or computer at their own pace, revisit modules and digital content as needed, and access a curated list of additional resources to supplement their learning. Receives: Other: Asynchronous self-directed digital training |
| Synchronous large group online workshop | Active comparator | This condition will reflect training as usual. Training will involve the same content contained in the asynchronous self-directed digital training platform, except delivered over a one day (4.5 hours of online instruction) workshop; and residents will be required to do the same reading and homework of lesson plans and viewing of the on-line videotaped role plays (an additional ~7.5 hours in total). Receives: Other: Synchronous large group online workshop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate - resident and patient participants
Number recruited per site per month for the intervention arm vs the control arm
Measured: 1.5 year recruitment period
Retention rate - resident and patient participants
Percentage of patient and resident participants retained and assessed with valid primary outcome data for the intervention vs control.
Measured: two years
Participation rate - resident participants
Percentage of resident participants who complete the online modules and homework assignments for the intervention vs control.
Measured: Assessed throughout the 2-3 weeks training period.
Secondary outcomes (9)
Acceptability of the intervention
We will assess acceptability by conducting a process evaluation; this will take the form of semi-structured interviews with all residents in the intervention to explore experiences of learning through the asynchronous self-directed online curriculum and platform along with facilitators and barriers to attaining the learning objectives of achieving competency in delivering IPT.
Measured: Immediately after resident participants' final session with their IPT patient.
Depression - patient participant
Depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9), a self-rating instrument that assesses symptoms of depression experienced during the past 2 weeks and is based on the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for MDD. Each of the nine items includes four possible responses related to symptom duration (e.g. not at all to nearly every day). Scores ≥10 (scale range 0-27) are often used to identify major depression.
Measured: up to 12 weeks
Anxiety - patient participant
Anxiety symptoms as measured by the General Anxiety Disorder-7 scale (GAD-7). The GAD-7 is a 7-item, self-rated scale developed as a screening tool and severity indicator for Generalized Anxiety Disorder. Items are rated on a 4-point Likert-type scale (0 = not at all to 3 = nearly every day). Scores range from 0 to 21 with higher scores indicating more severe GAD symptoms.
Measured: up to 12 weeks
Patient improvement - resident participant
Resident participants will fill in a measure of their global impression of their patient's improvement via the Clinical Global Impressions of Improvement (CGI-I) scale. This is a clinician rated scale that assesses the extent of clinical change in the patient at the point of assessment compared with baseline, and has a 7-point range, from 'Very much improved' 1 to 'Very much worse' 7. Higher scores signify greater severity and/or worse outcomes. The CGI-I has been found to be highly sensitive to change.
Measured: up to 12 weeks
Therapeutic alliance - patient participants
The Working Alliance Inventory-Short Revised (WAI-SR) is used by psychotherapists to assess and measure the therapeutic alliance for supervision and research purposes. The WAI-SR is a 12- item scale and consists of three subscales that measure three aspects of the therapeutic alliance: goals (agreement on the goals of therapy), tasks (agreement on the agenda of the therapy) and affective bond (development of relational bond between the client and the therapist). Each item is rated on a 7- point scale ranging from 1 (never) to 7 (always).
Measured: At week 3 and week 12.
Therapy quality - resident participant
The Brief IPT Checklist (BIC) will assess therapy quality. Developed by the study PI and used in other IPT-training initiatives in Ethiopia, China and Canada, this 15-item checklist includes essential IPT therapist behaviours across all sessions and within specific phases (beginning, middle or end). Response options for each item are recorded on a Likert scale of 0 (not done) to 4 (excellent). For consenting resident and patient pairs, each IPT therapy session will be audio recorded, and 1 randomly chosen from each of the early (sessions 1-2), middle (sessions 3-10) and late (sessions 11-12) phases of the therapy will be rated by independent experts in IPT (not study supervisors) and the resident therapist (after each therapy session) using the BIC.
Measured: up to 12 weeks
IPT knowledge - resident participant
IPT knowledge will be measured by a 25-item quiz derived from principles of IPT. The quiz will include case-based multiple-choice and short-answer questions that examine the trainees understanding of phase- and focus-specific therapeutic guidelines of IPT.
Measured: Baseline and at 12 weeks.
Counseling self-efficacy - resident participant
Counselling self-efficacy will be measured by using the counselling self-estimate inventory (COSE). It is a 42-item scale and includes both positive and negative statements about counselling self-efficacy. Respondents are asked to rate on a 6-point Likert scale from 1 (strongly disagree) to 6 (strongly agree) how they would perform in a counselling situation at the present time. The higher the score the stronger perception of counselling self-efficacy.
Measured: Baseline and the 12-week course of therapy.
Resident competence - resident participant
Resident participants will be assessed for competency through structured role plays using the investigator-developed Brief IPT Checklist (BIC) Using standardized patients, there will be two vignettes per resident on 2 differing IPT focal areas of social role transitions and disputes which will be rated by two experts in IPT (not study supervisors) on IPT-specific and general psychotherapy skills, on a scale of 0 (not done) to 2 (done well). The average score between the two role plays will be selected as a measure of the trainee competence. After the role play is finished, the standardized patients will be asked four questions to assess their impression of the resident participant's performance, and whether they would want to return for psychotherapy treatment with the resident.
Measured: Immediately after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start27 Jul 2020
- Primary completion30 Apr 2022
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (47)Papers the sponsor has linked to this study.
- Other trials for Education, MedicalStudies 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
- This is a mixed-methods feasibility and acceptability study, with a single blind randomized controlled design comparing asynchronous self-directed digital IPT training to a synchronous large group online IPT workshop.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre, Centre for Addiction and Mental Health, Women's College Hospital
- Responsible party
- Sponsor
- Investigators
- Paula Ravitz, MD, Principal investigator, Sinai Health SystemDaisy Singla, PhD, C. Psyc, Principal investigator, Sinai Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04619615
- Sponsor's protocol ID
- 19-0333-E
- Status last verified
- Mar 2022
- First submitted
- 26 Oct 2020
- Last updated
- 26 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ferrari AJ, Charlson FJ, Norman RE, Patten SB, Freedman G, Murray CJ, Vos T, Whiteford HA. Burden of depressive disorders by country, sex, age, and year: findings from the global burden of disease study 2010. PLoS Med. 2013 Nov;10(11):e1001547. doi: 10.1371/journal.pmed.1001547. Epub 2013 Nov 5.
PubMed 24223526Heinrich LM, Gullone E. The clinical significance of loneliness: a literature review. Clin Psychol Rev. 2006 Oct;26(6):695-718. doi: 10.1016/j.cpr.2006.04.002. Epub 2006 Jun 19.
PubMed 16952717Thornicroft G, Chatterji S, Evans-Lacko S, Gruber M, Sampson N, Aguilar-Gaxiola S, Al-Hamzawi A, Alonso J, Andrade L, Borges G, Bruffaerts R, Bunting B, de Almeida JM, Florescu S, de Girolamo G, Gureje O, Haro JM, He Y, Hinkov H, Karam E, Kawakami N, Lee S, Navarro-Mateu F, Piazza M, Posada-Villa J, de Galvis YT, Kessler RC. Undertreatment of people with major depressive disorder in 21 countries. Br J Psychiatry. 2017 Feb;210(2):119-124. doi: 10.1192/bjp.bp.116.188078. Epub 2016 Dec 1.
PubMed 27908899Cuijpers P, Donker T, Weissman MM, Ravitz P, Cristea IA. Interpersonal Psychotherapy for Mental Health Problems: A Comprehensive Meta-Analysis. Am J Psychiatry. 2016 Jul 1;173(7):680-7. doi: 10.1176/appi.ajp.2015.15091141. Epub 2016 Apr 1.
PubMed 27032627Ravitz P, Watson P, Lawson A, Constantino MJ, Bernecker S, Park J, Swartz HA. Interpersonal Psychotherapy: A Scoping Review and Historical Perspective (1974-2017). Harv Rev Psychiatry. 2019 May/Jun;27(3):165-180. doi: 10.1097/HRP.0000000000000219.
PubMed 30883446Elkin I, Shea MT, Watkins JT, Imber SD, Sotsky SM, Collins JF, Glass DR, Pilkonis PA, Leber WR, Docherty JP, et al. National Institute of Mental Health Treatment of Depression Collaborative Research Program. General effectiveness of treatments. Arch Gen Psychiatry. 1989 Nov;46(11):971-82; discussion 983. doi: 10.1001/archpsyc.1989.01810110013002.
PubMed 2684085Bass J, Neugebauer R, Clougherty KF, Verdeli H, Wickramaratne P, Ndogoni L, Speelman L, Weissman M, Bolton P. Group interpersonal psychotherapy for depression in rural Uganda: 6-month outcomes: randomised controlled trial. Br J Psychiatry. 2006 Jun;188:567-73. doi: 10.1192/bjp.188.6.567.
PubMed 16738348Bolton P, Bass J, Betancourt T, Speelman L, Onyango G, Clougherty KF, Neugebauer R, Murray L, Verdeli H. Interventions for depression symptoms among adolescent survivors of war and displacement in northern Uganda: a randomized controlled trial. JAMA. 2007 Aug 1;298(5):519-27. doi: 10.1001/jama.298.5.519.
PubMed 17666672Mufson L, Dorta KP, Wickramaratne P, Nomura Y, Olfson M, Weissman MM. A randomized effectiveness trial of interpersonal psychotherapy for depressed adolescents. Arch Gen Psychiatry. 2004 Jun;61(6):577-84. doi: 10.1001/archpsyc.61.6.577.
PubMed 15184237Cooper Z, Bailey-Straebler S, Morgan KE, O'Connor ME, Caddy C, Hamadi L, Fairburn CG. Using the Internet to Train Therapists: Randomized Comparison of Two Scalable Methods. J Med Internet Res. 2017 Oct 18;19(10):e355. doi: 10.2196/jmir.8336.
PubMed 29046265Ravitz P, Lawson A, Fefergrad M, Rawkins S, Lancee W, Maunder R, Leszcz M, Kivlighan DM Jr. Psychotherapy Competency Milestones: an Exploratory Pilot of CBT and Psychodynamic Psychotherapy Skills Acquisition in Junior Psychiatry Residents. Acad Psychiatry. 2019 Feb;43(1):61-66. doi: 10.1007/s40596-018-0940-4. Epub 2018 Jun 1.
PubMed 29858773Ravitz P, Cooke RG, Mitchell S, Reeves S, Teshima J, Lokuge B, Lawson A, McNaughton N, Skinner W, Cooper C, Fefergrad M, Zaretsky A. Continuing education to go: capacity building in psychotherapies for front-line mental health workers in underserviced communities. Can J Psychiatry. 2013 Jun;58(6):335-43. doi: 10.1177/070674371305800605.
PubMed 23768261Weingardt KR, Cucciare MA, Bellotti C, Lai WP. A randomized trial comparing two models of web-based training in cognitive-behavioral therapy for substance abuse counselors. J Subst Abuse Treat. 2009 Oct;37(3):219-27. doi: 10.1016/j.jsat.2009.01.002. Epub 2009 Mar 31.
PubMed 19339136Kobak KA, Lipsitz JD, Markowitz JC, Bleiberg KL. Web-Based Therapist Training in Interpersonal Psychotherapy for Depression: Pilot Study. J Med Internet Res. 2017 Jul 17;19(7):e257. doi: 10.2196/jmir.7966.
PubMed 28716769Fluckiger C, Del Re AC, Wampold BE, Horvath AO. The alliance in adult psychotherapy: A meta-analytic synthesis. Psychotherapy (Chic). 2018 Dec;55(4):316-340. doi: 10.1037/pst0000172. Epub 2018 May 24.
PubMed 29792475
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Access to Evidence-based Treatments for Depression: The Development and Evaluation of a Digital Training Platform for Interpersonal Psychotherapy.
- ClinicalTrials.gov ID
- NCT04619615
- Acronym / sponsor ID
- 19-0333-E
- Conditions
- Education, Medical
- Keywords
- Interpersonal Psychotherapy, Resident Education, Online Training, Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre, Centre for Addiction and Mental Health, Women's College Hospital
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 6 Nov 2020 (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 single-blind, randomized controlled pilot study is to evaluate the acceptability and feasibility of an Interpersonal Psychotherapy (IPT) asynchronous self-directed digital training platform for psychiatry residents, as compared to synchronous large group online workshop teaching. This study has the potential to improve access to competency-based training and dissemination of IPT, impacting healthcare delivery with increasing access to this evidence-based psychological depression treatment.
Detailed description
Background/Rational
The COVID-19 pandemic is expected to have an unprecedented impact on the mental health and well-being of patients, healthcare workers and our society at large. Among these illnesses, depression is expected to be the most prevalent to emerge and is already the leading cause of disability worldwide; it affects up to 1.8 million Canadians. While physical distancing is required to curb the spread of COVID-19, it is well known that social isolation is a substantive risk factor of mental illness and suicide.
Effective treatments exist but as few as 20% of Canadians receive minimally-adequate treatment for depression. One effective treatment for depression includes Interpersonal Psychotherapy (IPT) which may be particularly relevant for the isolation and life changes brought on by the COVID-19 pandemic. IPT is recommended in key consensus guidelines from the World Health Organization and the Canadian Network for Mood and Anxiety Treatments. IPT is a brief, structured psychological treatment that has been shown to effectively reduce depressive symptoms and enhance remission rates for patients across the lifespan. IPT proposes that the key to reducing depression is to increase connection with social supports and help patients work through triggering interpersonal experiences of loss/grief, life changes/social role transitions, interpersonal sensitivity/loneliness, or relational conflicts/role disputes. We selected IPT for three reasons: i) its strong evidence base for effectiveness as an antidepressant treatment, comparable in efficacy to CBT, with fewer patients dropping out of treatments; ii) its effectiveness in treating depression among culturally diverse patients across the lifespan; and iii) its parsimonious approach that is easy to understand and implement. This is critical when training novice clinicians. The poor dissemination of effective psychological therapies such as IPT is partly due to the limited number of available mental health professionals who can train novice clinicians with high fidelity; and one key obstacle is how these individuals are trained. Prior to the COVID-19 pandemic, this typically involved a trainee attending an expert-led workshop and then practicing the treatment under the supervision of someone experienced in delivering that treatment. The recent development of digital training platforms in various psychological treatments has attempted to address this training gap. In addition, web-conferencing applications have opened the door for distance psychotherapy training and supervision.
Online training methods need to be developed and examined to address this significant bottleneck, particularly in light of the current COVID-19 pandemic where in-person trainings have stopped but the need for evidence-based psychotherapy grows. The current study aims to examine two online training methods with consenting psychiatry resident/trainee therapists: a) asynchronous self-directed training through a novel digital training course which they will complete on their own schedule; and b) synchronous large group workshop where residents will participate in a live training workshop at a specific time. Asynchronous training is a more cost-effective and scalable method of training which permits residents (and other trainees) to learn psychotherapy according to their preferred schedules. To date, several asynchronous IPT training courses have been developed, however none have been compared to synchronous large group online workshop. The current study will provide preliminary evidence to examine the acceptability and feasibility of both models among psychiatry residents at University of Toronto affiliated hospitals.
Purpose
The main purpose of the current study is to examine the acceptability and feasibility of a digital training platform for psychiatry residents in IPT for depression treatment.
Aim 1. What is the feasibility of an asynchronous self-directed online digital training platform? To assess feasibility, we will examine psychiatric resident recruitment, and participation (completion of the online modules and homework assignments) for the intervention condition vs control (synchronous large group online workshop).
Aim 2. What is the acceptability of the asynchronous self-directed online digital training process and platform? We will assess acceptability by conducting a process evaluation; this will take the form of semi-structured interviews with all residents in the intervention to explore experiences of learning through the asynchronous self-directed online curriculum and platform along with facilitators and barriers to attaining the learning objectives of achieving competency in delivering IPT.
Aim 3. Does the asynchronous self-directed online training platform demonstrate preliminary efficacy when training PGY 2-5 psychiatry residents in IPT for depressed patients, as compared to a synchronous large group online workshop? This will be estimated by assessing changes in patient outcomes of depressive symptoms over the course of treatment. A secondary patient outcome will be changes in patient anxiety symptoms over the course of IPT treatment. In addition, therapist-related outcomes will be assessed including therapeutic alliance, therapy quality as assessed by IPT- specific skills and non-specific therapeutic communication skills, IPT-knowledge, and counseling self-efficacy.
Target Population
The target population are psychiatry residents in good standing with the University of Toronto (UofT), Faculty of Medicine, post-graduate psychiatry residency program, all of whom require training in IPT as part of the residency requirements, and their IPT patients. Specifically, this will include psychiatry residents from four UofT-affiliated hospitals, Mount Sinai Hospital (MSH), Women's College Hospital (WCH), Sunnybrook Health Sciences Centre (SHSC) and the Centre for Addition and Mental Health (CAMH).
Study Design
This is a mixed-methods feasibility and acceptability study, with a single blind randomized controlled design comparing asynchronous self-directed digital IPT training to a synchronous large group online IPT workshop. Patients will be blind to therapist study arm allocation.
Procedure
Residents doing clinical rotations at MSH, SHSC,WCH and CAMH as part of their Psychiatry Residency training at the University of Toronto will be approached for consent by the Research Coordinator (RC) at the beginning of each academic semester. Consenting resident participants will complete a measure of their counseling self-efficacy and IPT knowledge before randomization to the intervention or the control condition, stratified by study site (MSH, WCH, SHSC and CAMH). Patient recruitment will be through referrals via treatment providers at all study sites (MSH, SHSC, WCH, and CAMH). Patient participants will be stratified by site and then randomly assigned to residents in the intervention or control condition.
Resident participants will be randomized to one of two training conditions: (1) synchronous self-directed digital training (intervention condition), where residents will complete an interactive modular curriculum covering evidence-based psychotherapy principles and IPT-specific principles and strategies at their own pace over a two week time period; or (2) a synchronous online training workshop (control condition), which will involve the same content contained in the asynchronous self-directed digital training platform, except delivered over a one day online workshop.
Immediately after training has been completed, each resident participant will participate in structured role plays designed to assess the resident's competence on IPT-specific and general psychotherapy skills, as rated by two IPT experts. Resident participants will then begin their 12-week course of therapy with their assigned patient participant. During treatment delivery, residents will have once weekly one-on-one supervisory sessions with an IPT expert supervisor/faculty member of the University of Toronto, Department of Psychiatry, who will be blind to residents' foundational didactic training modality.
Patient participants will complete measures of their depressive and anxiety symptoms just before each weekly session, as well as a measure of therapeutic alliance at the 3rd and final therapy sessions. At every session resident participants will complete a measure of their impression of their patient's improvement (or lack thereof) as well as a measure of therapy quality. They will complete the measures of counseling self-efficacy and IPT knowledge at the conclusion of the course of therapy with their patient. Consenting resident-patient pairs will audio record each therapy session; these recordings will be transcribed and coded for therapy quality. Resident participants randomized to the intervention condition (asynchronous digital training) will complete a semi-structured interview exploring the barriers and facilitators to engaging with the digital training platform in order to assess the acceptability of the intervention.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a mixed-methods feasibility and acceptability study, with a single blind randomized controlled design comparing asynchronous self-directed digital IPT training to a synchronous large group online IPT workshop.
| Arm | Type | Receives |
|---|---|---|
| Asynchronous self-directed digital training | Experimental | Other: Asynchronous self-directed digital trainingA digital training program platform that delivers an interactive case-based modular curriculum covering evidence-based psychotherapy principles and IPT-specific principles and strategies with homework will take roughly 13 hours to complete, with 4.5 hours of online learning, and an additional 7.5 hours of reading and homework assignments. The reading and homework includes viewing captioned videotaped role plays and completing self-directed lesson plans. The digital curriculum leverages audio, video, and visual content, and is self-directed - for completion within a 2-week period. Residents can access this content through a smartphone, tablet or computer at their own pace, revisit modules and digital content as needed, and access a curated list of additional resources to supplement their learning. |
| Synchronous large group online workshop | Active comparator | Other: Synchronous large group online workshopThis condition will reflect training as usual. Training will involve the same content contained in the asynchronous self-directed digital training platform, except delivered over a one day (4.5 hours of online instruction) workshop; and residents will be required to do the same reading and homework of lesson plans and viewing of the on-line videotaped role plays (an additional ~7.5 hours in total). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Mount Sinai Hospital (MSH), Sunnybrook Health Sciences Centre (SHSC), Women's College Hospital (WCH) and the Centre for Addition and Mental Health (CAMH) PGY2-5 psychiatry residents treating patients
- Able to participate in the asynchronous self-directed on-line/synchronous large group online workshop
- Ability to add 1-2 patients to their caseload and provide a minimum of 12 IPT sessions over 6 months.
- Adults (≥18 years)
- Experiencing clinically significant depressive symptoms (defined as a score of ≥10 on the Patient Health Questionnaire-9, PHQ-9, during eligibility screening).
Key exclusion criteria (6 listed)
- Academic concerns as flagged by the University of Toronto General Psychiatry program as evidenced by a referral to the University of Toronto Psychiatry Resident Evaluation Subcommittee OR significant concerns regarding promotion or progression as flagged by the University of Toronto Psychiatry Post-graduate Competence Sub-committee (responsible for reviewing all resident files twice a year).
- Diagnosis of borderline personality disorder, or psychotic or manic symptoms
- Active alcohol or substance use disorder within the past 6 months, assessed by a score >1 on items "2" through "5" the Global Appraisal of Individual Needs-Short Screener (GAIN-SS).
- Self-harm and/or at high risk of suicide or suicidal behaviors, as assessed by a score of >1 on question 9 of the PHQ-9, followed by an assessment of active suicidal ideation on the Mini International Neuropsychiatric Interview (MINI), as confirmed by the site PI
- Severe symptoms of depression, defined as a score of ≥20 on the PHQ-9 during eligibility screening
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 |
|---|---|---|
| Asynchronous self-directed digital trainingResident participants will be able to complete the digital training at their own pace. | Other | Asynchronous self-directed digital training |
| Synchronous large group online workshopResident participants will complete the digital training platform in real time over the course of a one day, live workshop (4.5 hours of online instruction). | Other | Synchronous large group online workshop |
Primary outcome
Recruitment rate - resident and patient participants
Time frame: 1.5 year recruitment period
Number recruited per site per month for the intervention arm vs the control arm
Retention rate - resident and patient participants
Time frame: two years
Percentage of patient and resident participants retained and assessed with valid primary outcome data for the intervention vs control.
Participation rate - resident participants
Time frame: Assessed throughout the 2-3 weeks training period.
Percentage of resident participants who complete the online modules and homework assignments for the intervention vs control.
9 secondary outcomes
Acceptability of the intervention
Time frame: Immediately after resident participants' final session with their IPT patient.
Depression - patient participant
Time frame: up to 12 weeks
Anxiety - patient participant
Time frame: up to 12 weeks
Patient improvement - resident participant
Time frame: up to 12 weeks
Therapeutic alliance - patient participants
Time frame: At week 3 and week 12.
Therapy quality - resident participant
Time frame: up to 12 weeks
IPT knowledge - resident participant
Time frame: Baseline and at 12 weeks.
Counseling self-efficacy - resident participant
Time frame: Baseline and the 12-week course of therapy.
Resident competence - resident participant
Time frame: Immediately after the intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2022.
- Background: PubMed 24223526Ferrari AJ, Charlson FJ, Norman RE, Patten SB, Freedman G, Murray CJ, Vos T, Whiteford HA. Burden of depressive disorders by country, sex, age, and year: findings from the global burden of disease study 2010. PLoS Med. 2013 Nov;10(11):e1001547. doi: 10.1371/journal.pmed.1001547. Epub 2013 Nov 5.
- Background: PubMed 16952717Heinrich LM, Gullone E. The clinical significance of loneliness: a literature review. Clin Psychol Rev. 2006 Oct;26(6):695-718. doi: 10.1016/j.cpr.2006.04.002. Epub 2006 Jun 19.
- Background: PubMed 27908899Thornicroft G, Chatterji S, Evans-Lacko S, Gruber M, Sampson N, Aguilar-Gaxiola S, Al-Hamzawi A, Alonso J, Andrade L, Borges G, Bruffaerts R, Bunting B, de Almeida JM, Florescu S, de Girolamo G, Gureje O, Haro JM, He Y, Hinkov H, Karam E, Kawakami N, Lee S, Navarro-Mateu F, Piazza M, Posada-Villa J, de Galvis YT, Kessler RC. Undertreatment of people with major depressive disorder in 21 countries. Br J Psychiatry. 2017 Feb;210(2):119-124. doi: 10.1192/bjp.bp.116.188078. Epub 2016 Dec 1.
- Background: PubMed 27032627Cuijpers P, Donker T, Weissman MM, Ravitz P, Cristea IA. Interpersonal Psychotherapy for Mental Health Problems: A Comprehensive Meta-Analysis. Am J Psychiatry. 2016 Jul 1;173(7):680-7. doi: 10.1176/appi.ajp.2015.15091141. Epub 2016 Apr 1.
- Background: PubMed 30883446Ravitz P, Watson P, Lawson A, Constantino MJ, Bernecker S, Park J, Swartz HA. Interpersonal Psychotherapy: A Scoping Review and Historical Perspective (1974-2017). Harv Rev Psychiatry. 2019 May/Jun;27(3):165-180. doi: 10.1097/HRP.0000000000000219.
- Background: PubMed 2684085Elkin I, Shea MT, Watkins JT, Imber SD, Sotsky SM, Collins JF, Glass DR, Pilkonis PA, Leber WR, Docherty JP, et al. National Institute of Mental Health Treatment of Depression Collaborative Research Program. General effectiveness of treatments. Arch Gen Psychiatry. 1989 Nov;46(11):971-82; discussion 983. doi: 10.1001/archpsyc.1989.01810110013002.
- Background: PubMed 16738348Bass J, Neugebauer R, Clougherty KF, Verdeli H, Wickramaratne P, Ndogoni L, Speelman L, Weissman M, Bolton P. Group interpersonal psychotherapy for depression in rural Uganda: 6-month outcomes: randomised controlled trial. Br J Psychiatry. 2006 Jun;188:567-73. doi: 10.1192/bjp.188.6.567.
- Background: PubMed 17666672Bolton P, Bass J, Betancourt T, Speelman L, Onyango G, Clougherty KF, Neugebauer R, Murray L, Verdeli H. Interventions for depression symptoms among adolescent survivors of war and displacement in northern Uganda: a randomized controlled trial. JAMA. 2007 Aug 1;298(5):519-27. doi: 10.1001/jama.298.5.519.
- Background: PubMed 15184237Mufson L, Dorta KP, Wickramaratne P, Nomura Y, Olfson M, Weissman MM. A randomized effectiveness trial of interpersonal psychotherapy for depressed adolescents. Arch Gen Psychiatry. 2004 Jun;61(6):577-84. doi: 10.1001/archpsyc.61.6.577.
- Background: PubMed 29046265Cooper Z, Bailey-Straebler S, Morgan KE, O'Connor ME, Caddy C, Hamadi L, Fairburn CG. Using the Internet to Train Therapists: Randomized Comparison of Two Scalable Methods. J Med Internet Res. 2017 Oct 18;19(10):e355. doi: 10.2196/jmir.8336.
- Background: PubMed 29858773Ravitz P, Lawson A, Fefergrad M, Rawkins S, Lancee W, Maunder R, Leszcz M, Kivlighan DM Jr. Psychotherapy Competency Milestones: an Exploratory Pilot of CBT and Psychodynamic Psychotherapy Skills Acquisition in Junior Psychiatry Residents. Acad Psychiatry. 2019 Feb;43(1):61-66. doi: 10.1007/s40596-018-0940-4. Epub 2018 Jun 1.
- Background: PubMed 23768261Ravitz P, Cooke RG, Mitchell S, Reeves S, Teshima J, Lokuge B, Lawson A, McNaughton N, Skinner W, Cooper C, Fefergrad M, Zaretsky A. Continuing education to go: capacity building in psychotherapies for front-line mental health workers in underserviced communities. Can J Psychiatry. 2013 Jun;58(6):335-43. doi: 10.1177/070674371305800605.
- Mental Health Commission of Canada websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paula Ravitz, MD principal investigator
Sinai Health System
Daisy Singla, PhD, C. Psyc principal investigator
Sinai Health System
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Asynchronous self-directed digital training and Synchronous large group online workshop in people with Education, Medical, run by Mount Sinai Hospital, Canada at 4 sites in Canada.
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 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 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 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate - resident and patient participants (time frame: 1.5 year recruitment period). The study lists 3 primary outcomes in all. 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 NCT04619615, which also lists 47 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 26 Sep 2022.