NCT03453957

Brief Summary

This study evaluates a professional development program intended to improve the relationship or alliance between therapists and patients/clients who are receiving psychotherapy in the community. Half of the participating therapists will receive training to detect and improve alliance with new patients while half will not. The professional development training is expected to improve therapists effectiveness in identifying and correcting alliance tensions which will, in turn, improve therapeutic outcomes for patients/clients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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 Start

First participant enrolled

February 1, 2018

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 5, 2018

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2021

Completed
Last Updated

May 1, 2026

Status Verified

June 1, 2022

Enrollment Period

3.3 years

First QC Date

February 16, 2018

Last Update Submit

April 27, 2026

Conditions

Keywords

Practice based research

Outcome Measures

Primary Outcomes (1)

  • Mean tension resolution rating scale

    The Rupture Resolution Rating System (3RS) is an observer-based measure to identify alliance tensions and resolution processes. Independent blind reliable trained judges will rate video recordings of 6 psychotherapy session recorded with participating clients. A mean tension score will be assigned per client which will be the average of the 6 session scores. score ranges from 1 (withdrawal/confrontation rupture(s) did not occur; not significant for the alliance) to 5 (withdrawal/confrontation rupture(s) occurred; significant for the alliance).

    6 therapy sessions over 6 weeks up to 6 months depending on the frequency of therapy

Secondary Outcomes (2)

  • Generalized Anxiety Disorder 7-item scale (GAD-7) change from baseline

    baseline and end of 6 therapy sessions, 6 weeks to 6 months depending on the frequency of therapy

  • Patient Health Questionnaire 9-item scale (PHQ-9) change from baseline

    baseline and end of 6 therapy sessions, 6 weeks to 6 months depending on the frequency of therapy

Study Arms (2)

Professional Development Program

EXPERIMENTAL

Therapists who participate in workshops and consultation sessions with study trainers during study-related therapy sessions and their participating patients/clients.

Other: Professional development program

Control

NO INTERVENTION

Therapists who did not participate in workshops and consultations sessions while engaging in study-related therapy sessions and their participating patients/clients.

Interventions

Professional development program consists of training including workshops and consultation sessions to enhance therapists ability to detect and repair alliance ruptures in active community based psychotherapy.

Professional Development Program

Eligibility Criteria

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

You may qualify if:

  • regulated health professional
  • in good standing with a Canadian provincial regulatory college
  • scope of practice includes psychotherapy
  • ability to add 3 or more new, English speaking clients to caseload over 6 to 9 months
  • ability to obtain timely permission to conduct research from therapist's employing institution or health group when applicable

You may not qualify if:

  • none
  • Patient/Client
  • years of age or older
  • will participate in psychotherapy sessions in English
  • will see the study-affiliated therapist for a minimum of 6 sessions in the next 6 months
  • already seeing another therapist
  • diagnosed with a neurocognitive disorder
  • diagnosed with a psychotic disorder
  • expressed suicidal behaviour in the past six months as assessed by their participating therapist

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Ottawa

Ottawa, Ontario, K1N 6N5, Canada

Location

Mt. Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Related Links

Study Officials

  • Giorgio Tasca, Ph.D.

    University of Ottawa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participating therapists will be aware of their group (Asynchronous virtual training, synchronous virtual workshop training, no training control); however, their participating patient/clients will not know which experimental group their therapists belongs to.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This will be a 2-arm, parallel, prospective, single-blind cluster RCT with 1-1 allocation comparing: (a) therapists who receive the professional development intervention to identify and repair alliance tensions at the study outset versus (b) therapists who receive the intervention after participation is complete (no training control). Therapists will be randomized to study condition and patients will be clustered within therapists. Randomization will control for: (a) the effect of therapist variables (age, gender, theoretical orientation, experience, differing initial skill level) on competence, therapeutic alliance, or patient outcomes; (b) potential biases caused by pre-treatment patient variables (symptom severity, co-morbidity, chronicity, psychoactive medications); and (c) treatment or study factors (e.g. frequency of sessions, time to complete the study sessions, treatment received after the study sessions). Patients will be blind to therapist study arm allocation.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 16, 2018

First Posted

March 5, 2018

Study Start

February 1, 2018

Primary Completion

May 14, 2021

Study Completion

August 14, 2021

Last Updated

May 1, 2026

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations