NCT07087730

Brief Summary

Several types of psychotherapy are equally effective to treat mental disorders. However, many patients remain symptomatic after treatment. The investigators demonstrated that a professional development training program to improve psychotherapists' skills at identifying and repairing therapeutic alliance tensions resulted in improved therapeutic alliance (an important therapeutic ingredient) and patient mental health outcomes. However, the investigators delivered this training program by conventional in-person workshops which limited access by psychotherapists living outside large urban centres. Further, post-study interviews with therapists suggested that cultural/diversity factors complicated the therapeutic alliance. In the current study, the investigators will test the effectiveness and acceptability of a virtually-delivered training program to psychotherapists in North America to improve their capacity to identify and repair problems in the therapeutic alliance, including tensions related to patient diversity. The investigators will also examine how acceptable the virtually-delivered training is to psychotherapists and whether they would use such training in their practice. Participants in the study will be community-based licensed psychotherapists and their patients engaging in therapy in North America. Patient mental health outcomes, therapeutic alliance, and diversity issues will be assessed by comparing outcome measures between three groups: 1) therapists complete a self-paced virtual course + consultation, 2) therapists complete synchronous workshop + consultation, 3) control: therapists do not complete training. The team of investigators developed Canada's largest psychotherapy practice-research network and has expertise in clinical trials, diversity, and education research of virtual training. State of the art training is often out of the reach of therapists who live outside of urban centres, and the effectiveness and acceptability of providing training virtually is not well-studied in mental health care. This study will improve psychotherapists' effectiveness at managing the therapeutic alliance and issues related to diversity, and will improve patient mental health outcomes thus promising to reduce the burden of mental illness.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
489

participants targeted

Target at P75+ for not_applicable

Timeline
12mo left

Started Aug 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress74%
Aug 2023May 2027

Study Start

First participant enrolled

August 2, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2024

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

July 28, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

July 28, 2025

Status Verified

July 1, 2025

Enrollment Period

3.3 years

First QC Date

April 23, 2024

Last Update Submit

July 18, 2025

Conditions

Keywords

PsychotherapistsPsychotherapyOutcome Assessment, HealthcareCultural DiversityHumansMental DisordersTelemedicine

Outcome Measures

Primary Outcomes (2)

  • Working Alliance Inventory (WAI) therapist or patient short form

    12-item self-report measure used to assess the therapeutic alliance by either therapist or client. Yields scores on three subscales: task, bond, and goal. Min subscale score is 12, max score is 84 with higher scores indicate greater alliance.

    Patients and therapists will complete it after each of 6 consecutive study psychotherapy session (frequency will range from once a week to once a month depending on the client's typical session interval).

  • Ruptures Resolution Rating System (3RS)

    Observer-based coding system for identifying therapeutic alliance ruptures and resolutions.

    Sessions will be coded by trained raters after all session recordings have been collected.

Secondary Outcomes (21)

  • Patient Health Questionnaire (PHQ-9)

    Patients will complete it before starting study psychotherapy sessions, after completing all study sessions (6 weeks to 6 months depending on the client's typical session interval), and at 3-month follow-up.

  • Generalized Anxiety Disorder questionnaire (GAD-7)

    Patients will complete it before starting study psychotherapy sessions, after completing all study sessions (6 weeks to 6 months depending on the client's typical session interval), and at 3-month follow-up.

  • Inventory of Interpersonal Problems (IIP-32)

    Patients will complete it before starting study psychotherapy sessions (6 weeks to 6 months depending on the client's typical session interval), after completing all study sessions, and at 3-month follow-up.

  • Defense Mechanism Rating Scales (DMRS-SR-30)

    Patients will complete it before starting study psychotherapy sessions, after completing all study sessions (6 weeks to 6 months depending on the client's typical session interval), and at 3-month follow-up.

  • Experiences in Close Relationships (ECR-12)

    Patients will complete it before starting study psychotherapy sessions and 3 months after completing therapy sessions. Therapists will completed it before receiving training.

  • +16 more secondary outcomes

Other Outcomes (5)

  • Cultural Humility Scale (CHS)

    Patients will complete the measure after completing all study therapy sessions.

  • Sexist Microaggression Scale (MAWS)

    Patients who self-identify as women will complete it after each study psychotherapy session (over 6 weeks to 6 months depending on the frequency of sessions).

  • Racial Microaggressions in Counseling Scale (RMSC)

    Patients who self-identify with a marginalized race will complete it after each study psychotherapy session. Sessions will occur over a 6 week to 6 month period depending on the frequency of sessions.

  • +2 more other outcomes

Study Arms (3)

Virtual Training Program

EXPERIMENTAL

Asynchronous virtual training professional development program including consultation.

Behavioral: Virtual Training Program

Training as Usual

ACTIVE COMPARATOR

Synchronous virtual workshop professional development including consultation.

Behavioral: Training as Usual

No Training

ACTIVE COMPARATOR

No training, therapy as usual.

Behavioral: No Training

Interventions

Therapists randomized to this condition will receive the professional development via an asynchronous virtual training course. The Virtual Training will include written material, videos, interactive learning activities, and a text-based discussion forum where therapists and faculty will be able to interact in relation to the given activities. Clinical scenario and simulation-based interactive learning will allow therapists to explore clinical situations, make decisions, and evaluate consequences of their actions in a safe environment. Therapists will complete 6 study-related therapy sessions with 3 new patients. After therapists receive the Virtual Training and after they enroll their first patient, therapists will attend bi-weekly 1-hour online consultation meetings that include up to 6 therapists at a time and led by two of the training faculty. Each therapist will attend 10 of these posttraining consultation sessions.

Virtual Training Program

Therapists randomized to this condition will receive the professional development training via a 3-day synchronous workshop delivered via video conference covering the same didactic content as the virtual training course. The workshop will include lectures, written material, videos, and live role play activities. Therapists will complete 6 study-related sessions with 3 new patients. After therapists receive the professional development through Training as Usual and after they enroll their first patient, therapists will attend bi-weekly 1-hour online consultation meetings that include up to 6 therapists at a time and led by two of the training faculty. Each therapist will attend 10 of these posttraining consultation sessions.

Training as Usual
No TrainingBEHAVIORAL

Therapists randomized to this control condition will provide psychotherapy via the study video conference platform to 3 new enrolled patients in their typical manner except that they and their patients will also complete the assessments necessary for the study. After study completion, the investigators will provide therapists in the control condition with access to virtual training.

No Training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Therapist participants: The investigators will exclude therapists who are employed by an organization if the investigators cannot obtain organizational approval from their employer or coordinate data collection from an alternate virtual platform in instances where the employing organization does not permit the use of the study platform. Therapists will also be excluded if they have completed professional development workshop after 2017 with PPRNet.
  • Patient participants: The investigators will exclude patients if they: (a) have a psychotic or neurocognitive disorder that may preclude engagement in psychotherapy, (b) are in concurrent psychological treatment with another practitioner, (c) are at high risk of suicide or suicidal behaviors as assessed by their therapist (e.g., suicide attempt or hospitalization for suicidal behaviors in the past 6 months), or (d) for whom the therapist judge that approaching them with information about the study will be harmful.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ottawa

Ottawa, Ontario, K1N 6N5, Canada

RECRUITING

Related Links

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • Giorgio A Tasca, PhD

    University of Ottawa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Giorgio A Tasca, PhD

CONTACT

Stephanie Baker, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Patients will be blind to therapist study arm allocation.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 3-arm, prospective, single blind randomized controlled trial with 2-1-1 allocation comparing (i) Virtual training, (ii) training as usual, (iii) no training.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Full Professor

Study Record Dates

First Submitted

April 23, 2024

First Posted

July 28, 2025

Study Start

August 2, 2023

Primary Completion (Estimated)

December 5, 2026

Study Completion (Estimated)

May 1, 2027

Last Updated

July 28, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations