Increasing Access to Evidence-based Treatments for Depression

• ClinicalTrials.gov Identifier: NCT04619615
• Recruitment Status: Recruiting
• First Posted: November 6, 2020
• Last Update Posted: November 6, 2020
• Sponsor: Mount Sinai Hospital, Canada
• Collaborators: Sunnybrook Health Sciences Centre; Centre for Addiction and Mental Health; Women's College Hospital
• Information provided by (Responsible Party): Mount Sinai Hospital, Canada

Study Description

Brief 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. 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.

Condition or disease	Intervention/treatment	Phase
Education, Medical	Other: Asynchronous self-directed digital training; Other: Synchronous large group online workshop	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 87 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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 (Participant)
• Masking Description: Patient participants will be blind to which training modality their resident therapist has been randomized to.
• Primary Purpose: Other
• Official Title: Increasing Access to Evidence-based Treatments for Depression: The Development and Evaluation of a Digital Training Platform for Interpersonal Psychotherapy.
• Actual Study Start Date: July 27, 2020
• Estimated Primary Completion Date: December 2021
• Estimated Study Completion Date: July 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Asynchronous self-directed digital training; 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.	Other: Asynchronous self-directed digital training; Resident participants will be able to complete the digital training at their own pace.
Active Comparator: Synchronous large group online workshop; 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).	Other: Synchronous large group online workshop; 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).

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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.
3. 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.

Secondary Outcome Measures :

1. Acceptability of the intervention [ Time Frame: Immediately after resident participants' final session with their IPT patient. ]
   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.
2. Depression - patient participant [ Time Frame: up to 12 weeks ]
   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.
3. Anxiety - patient participant [ Time Frame: up to 12 weeks ]
   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.
4. Patient improvement - resident participant [ Time Frame: up to 12 weeks ]
   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.
5. Therapeutic alliance - patient participants [ Time Frame: At week 3 and week 12. ]
   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).
6. Therapy quality - resident participant [ Time Frame: up to 12 weeks ]
   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.
7. IPT knowledge - resident participant [ Time Frame: Baseline and at 12 weeks. ]
   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.
8. Counseling self-efficacy - resident participant [ Time Frame: Baseline and the 12-week course of therapy. ]
   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.
9. Resident competence - resident participant [ Time Frame: Immediately after the intervention. ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria - Residents

• 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.

Exclusion Criteria - Residents

• 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).

Inclusion Criteria - Patients

• 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

Exclusion Criteria - Patients

• 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

Contacts and Locations

Contacts

Contact: Shahana Sittamapalam, BA; 416-586-4800; Shahana.Sittamapalam@sinaihealth.ca

Contact: Andrea Lawson, PhD; andrea.lawson@wchospital.ca

Locations

Canada, Ontario

Sunnybrook Health Sciences Centre; Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contact: Sophie Grigoriadis, MD, MA, PhD 416-480-5677 sophie.grigoriadis@sunnybrook.ca

Principal Investigator: Mark Fefergrad, MD

Principal Investigator: Sophie Grigoriadis, MD, MA, PhD

Mount Sinai Hospital; Recruiting

Toronto, Ontario, Canada, M5G 1X5

Contact: Shahana Sittamapal, BA Shahana.Sittamapalam@sinaihealth.ca

Principal Investigator: Paula Ravitz, MD

Principal Investigator: Daisy Singla, PhD, C. Psyc

Women's College Hospital; Not yet recruiting

Toronto, Ontario, Canada, M5S 1B2

Contact: Simone Vigod, MD, MSc 416-323-6400 ext 4080 simone.vigod@wchospital.ca

Contact: Maria Michalowska 416-323-6400 Maria.Michalowska@wchospital.ca

Principal Investigator: Simone Vigod, MD, MSc

Sub-Investigator: Andrea Lawson, PhD

The Centre for Addiction and Mental Health; Not yet recruiting

Toronto, Ontario, Canada, M6J 1H4

Contact: Sophie Soklaridis, PhD (416) 535-8501 sophie.soklaridis@camh.ca

Principal Investigator: Sophie Soklaridis, PhD

Sub-Investigator: Jan Malat, MD

Sponsors and Collaborators

Mount Sinai Hospital, Canada

Sunnybrook Health Sciences Centre

Centre for Addiction and Mental Health

Women's College Hospital

Investigators

• Principal Investigator: Paula Ravitz, MD; Sinai Health System
• Principal Investigator: Daisy Singla, PhD, C. Psyc; Sinai Health System

More Information

Additional Information:

Mental Health Commission of Canada website 

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• Responsible Party: Mount Sinai Hospital, Canada
• ClinicalTrials.gov Identifier: NCT04619615
• Other Study ID Numbers: 19-0333-E
• First Posted: November 6, 2020
• Last Update Posted: November 6, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mount Sinai Hospital, Canada:

Interpersonal Psychotherapy; Resident Education; Online Training; Depression

Additional relevant MeSH terms:

Depression; Behavioral Symptoms