Clinical trial NCT04619615: Increasing Access to Evidence-based Treatments for Depression
Official title: Increasing Access to Evidence-based Treatments for Depression: The Development and Evaluation of a Digital Training Platform for Interpersonal Psychotherapy.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Education, Medical
Keywords: Interpersonal Psychotherapy
Resident Education
Online Training
Depression
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
Collaborators: name: Sunnybrook Health Sciences Centre
name: Centre for Addiction and Mental Health
name: Women's College Hospital
First posted: 2020-11-06
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.

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.

Eligibility 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

Primary outcomes:
measure: Recruitment rate - resident and patient participants
timeFrame: 1.5 year recruitment period
measure: Retention rate - resident and patient participants
timeFrame: two years
measure: Participation rate - resident participants
timeFrame: Assessed throughout the 2-3 weeks training period.
Secondary outcomes:
measure: Acceptability of the intervention
timeFrame: Immediately after resident participants' final session with their IPT patient.
measure: Depression - patient participant
timeFrame: up to 12 weeks
measure: Anxiety - patient participant
timeFrame: up to 12 weeks
measure: Patient improvement - resident participant
timeFrame: up to 12 weeks
measure: Therapeutic alliance - patient participants
timeFrame: At week 3 and week 12.
measure: Therapy quality - resident participant
timeFrame: up to 12 weeks
measure: IPT knowledge - resident participant
timeFrame: Baseline and at 12 weeks.
measure: Counseling self-efficacy - resident participant
timeFrame: Baseline and the 12-week course of therapy.
measure: Resident competence - resident participant
timeFrame: Immediately after the intervention.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: Women's College Hospital
state: Ontario
city: Toronto
country: Canada
facility: The Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Sinai Health System
name: Paula Ravitz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sinai Health System
name: Daisy Singla, PhD, C. Psyc
role: PRINCIPAL_INVESTIGATOR
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