Increasing Access to Evidence-based Treatments for Depression

NCT04619615 | Unknown

• 1 other identifier: 19-0333-E
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 4

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.

Conditions

Education, Medical

Keywords

Interpersonal Psychotherapy; Resident Education; Online Training; Depression

Outcome Measures

Primary Outcomes (3)

• Recruitment rate - resident and patient participants

  Number recruited per site per month for the intervention arm vs the control arm

  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.

  two years

• Participation rate - resident participants

  Percentage of resident participants who complete the online modules and homework assignments for the intervention vs control.

  Assessed throughout the 2-3 weeks training period.

Secondary Outcomes (9)

• Acceptability of the intervention

  Immediately after resident participants' final session with their IPT patient.

• Depression - patient participant

  up to 12 weeks

• Anxiety - patient participant

  up to 12 weeks

• Patient improvement - resident participant

  up to 12 weeks

• Therapeutic alliance - patient participants

  At week 3 and week 12.

Study Arms (2)

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.

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).

Other: Synchronous large group online workshop

Interventions

Asynchronous self-directed digital training OTHER

Resident participants will be able to complete the digital training at their own pace.

Asynchronous self-directed digital training

Synchronous large group online workshop OTHER

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).

Synchronous large group online workshop

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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
• 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

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead
• Sunnybrook Health Sciences Centre: collaborator
• Centre for Addiction and Mental Health: collaborator
• Women's College Hospital: collaborator

Study Sites (4)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Location

The Centre for Addiction and Mental Health

Toronto, Ontario, M6J 1H4, Canada

Location

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Related Links

• Mental Health Commission of Canada website

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Paula Ravitz, MD

  Sinai Health System

  PRINCIPAL INVESTIGATOR

• Daisy Singla, PhD, C. Psyc

  Sinai Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patient participants will be blind to which training modality their resident therapist has been randomized to.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: November 6, 2020
• Study Start: July 27, 2020
• Primary Completion: April 30, 2022
• Study Completion: December 30, 2022
• Last Updated: September 26, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)