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Therapeutic Alliance Tensions and Repair in Psychotherapy Practices

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ClinicalTrials.gov Identifier: NCT03453957
Recruitment Status : Recruiting
First Posted : March 5, 2018
Last Update Posted : March 5, 2018
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Giorgio A. Tasca, University of Ottawa

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.

Condition or disease Intervention/treatment Phase
Psychotherapy Therapeutic Alliance Other: Professional development program Not Applicable

Detailed Description:
Psychotherapy is the treatment of choice for many mental disorders, yet there is a gap between research and practice. Research indicates that: the therapist-patient alliance is important to reduce patient symptoms, alliance tensions are detrimental to patients, and those therapists who identify and repair alliance tensions can improve patient outcomes. In this study we will use state of the art research to train community-based therapists in evidence-based interventions to identify and repair alliance tensions. Trained therapists and their patients will be compared to therapists who provide usual care to their patients. We will measure improvement in therapists' skills in identifying and repairing alliance tensions and how this is associated with better patient mental health outcomes. We will also interview trained therapists to identify the best ways of improving the training and disseminating the findings to psychotherapists across Canada. Research to improve practicing therapists' ability to identify and repair therapeutic alliance tensions will result in better mental health outcomes for patients.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Single (Participant)
Masking Description: Participating therapists will be aware of their group (Professional development training vs no training control); however, their participating patient/clients will not know which experimental group their therapists belongs to.
Primary Purpose: Health Services Research
Official Title: Therapeutic Alliance Tensions and Repair in Psychotherapy Practices: A Psychotherapy Practice Research Network (PPRNet) Study
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : February 2020

Arm Intervention/treatment
Experimental: Professional Development Program
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
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.

No Intervention: Control
Therapists who did not participate in workshops and consultations sessions while engaging in study-related therapy sessions and their participating patients/clients.



Primary Outcome Measures :
  1. Mean tension resolution rating scale [ Time Frame: 6 therapy sessions - 6 weeks ]
    The Rupture Resolution Rating System (3RS) is an observer-based measure to identify alliance tensions and resolution processes, and strategies therapists might use to resolve alliance tensions. Independent blind reliable trained judges will rate video recordings made during 6 psychotherapy session with participating clients and provide a mean tension resolution score.


Secondary Outcome Measures :
  1. Generalized Anxiety Disorder 7-item scale (GAD-7) change following therapy [ Time Frame: baseline and end of 6 therapy sessions, typically 7 weeks ]
    Self-report measurement of severity of anxiety using the GAD-7 scale. A change in anxiety scores will be assess following 6 therapy session with data collected before therapy and again after all 6 sessions of therapy have been completed.

  2. Patient Health Questionnaire 9-item scale (PHQ-9) change following therapy [ Time Frame: baseline and end of 6 therapy sessions, typically 7 weeks ]
    Self-report measurement of depression symptoms using the PHQ-9 scale. A change in depression symptom scores will be assess following 6 therapy session with data collected before therapy and again after all 6 sessions of therapy have been completed.



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

Therapist

Inclusion Criteria:

  • 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

Exclusion Criteria:

Patient/Client

Inclusion Criteria:

  • 18 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03453957


Contacts
Contact: Giorgio Tasca, Ph.D. 1-613-562-5800 ext 3890 GTASCA@uottawa.ca
Contact: Stephanie Baker, Ph.D. 1-562-5800 ext 4218 pprnet@uottawa.ca

Locations
Canada, Ontario
University of Ottawa Recruiting
Ottawa, Ontario, Canada, K1N 6N5
Contact: Giorgio Tasca, Ph.D, C.Psych.    1-613-562-5800 ext 3890    GTASCA@uottawa.ca   
Contact: Stephanie Baker, Ph.D    1-613-562-5800 ext 4218    pprnet@uottawa.ca   
Mt. Sinai Hospital Recruiting
Toronto, Ontario, Canada, M5G 1X5
Contact: Paula Ravitz, M.D.       Paula.Ravitz@sinaihealthsystems.ca   
Sponsors and Collaborators
University of Ottawa
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Giorgio Tasca, Ph.D. University of Ottawa

Additional Information:
Responsible Party: Giorgio A. Tasca, Associate Professor, University of Ottawa
ClinicalTrials.gov Identifier: NCT03453957     History of Changes
Other Study ID Numbers: 363733
First Posted: March 5, 2018    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: February 2018
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 Giorgio A. Tasca, University of Ottawa:
Practice based research