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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02023736
Other study ID # TFI-001
Secondary ID
Status Recruiting
Phase N/A
First received December 19, 2013
Last updated August 8, 2016
Start date December 2013
Est. completion date August 2017

Study information

Verified date August 2016
Source The Family Institute at Northwestern University
Contact Jacob Z Goldsmith, Ph.D.
Phone 847 733 4300
Email jgoldsmith2@family-institute.org
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

This study is a comparison of client outcomes in two different types of psychotherapy treatment. In one condition clients will receive treatment-as-usual (TAU); the therapy that they would normally receive. In the other condition clients will receive treatment-as-usual but in addition their therapist will have access to empirical feedback on client progress. Clients in the feedback condition will fill out weekly online questionnaires, and their therapists will have access to a website that feeds back the results of these questionnaires. The purpose of the study is to understand the impact of providing such feedback to therapists. Participating therapists at 4 sites will offer all of their clients the opportunity to participate, and participating clients will be randomly assigned to either condition. This should result in a representative sample of client seeking treatment at these 4 Chicago-area clinics.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date August 2017
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender Both
Age group 12 Years and older
Eligibility Inclusion Criteria:

- Client seeks therapy at one of the 4 participating sites

- For Individual therapy: client must consent and complete pre-test battery before the first therapy session

- For couple therapy: both clients must consent and complete pre-test battery before the first therapy session

- For family therapy: at least one client must consent and complete pre-test battery before the first therapy session

- Clients must be 12 years of age or older

- Clients must be able to read (English or Spanish) at a 6th grade level

Exclusion Criteria:

- Clients under 12 years of age

- Clients incapable of reading at a 6th grade level

- Clients who are blind, or are have sufficiently impaired sight as to be unable to read the questions on the web portal

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Other:
Systemic Therapy Inventory of Change (STIC)
The STIC is a computerized measurement and feedback system for use in psychotherapy. The measurement system consists of weekly questionnaires, completed on the computer, that target symptoms and functioning in a variety of domains of a clients life (e.g., individual symptoms, couple functioning, family functioning, relationship with children). The feedback system consists of a web-portal where therapists may access their clients' STIC responses, for the purposes of planning treatment, assessing progress, and discussing change with clients.
Treatment as Usual
Clients receive psychotherapy treatment as planned and implemented by their psychotherapists. Exact type of treatment varies by therapist and according to client need.

Locations

Country Name City State
United States Catholic Charities Chicago Illinois
United States Community Counseling Centers of Chicago Chicago Illinois
United States Jewish Child and Family Services Chicago Illinois
United States The Family Institute at Northwestern University Evanston Illinois

Sponsors (5)

Lead Sponsor Collaborator
The Family Institute at Northwestern University Catholic Charities, Community Counseling Centers of Chicago, Jewish Child and Family Services, The Chicago Community Trust

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in mental health symptoms at termination Clients complete a self-report outcome packet measuring mental health symptoms, tailored to their demographics, including some or all of the following:
Beck Depression Inventory II:
Beck Anxiety Inventory:
Outcome Questionnaire 45:
Short-form 36 Health Survey:
Revised Dyadic Adjustment Scale:
Family Assessment Device:
Strengths-Difficulties Questionnaire.
At the termination of therapy (varies naturally case-to-case, but an average of 7 weeks) clients complete the outcome packet that asks about mental health symptoms in the previous month. No
Secondary Change in mental health symptoms at 6-month follow up Clients complete a self-report outcome packet measuring mental health symptoms, tailored to their demographics, including some or all of the following:
Beck Depression Inventory II:
Beck Anxiety Inventory:
Outcome Questionnaire 45:
Short Form 36 Health Survey:
Revised Dyadic Adjustment Scale:
Family Assessment Device:
Strengths-Difficulties Questionnaire.
6 months post termination No
Secondary Change in mental health symptoms at 12-month follow-up Clients complete a self-report outcome packet measuring mental health symptoms, tailored to their demographics, including some or all of the following:
Beck Depression Inventory II:
Beck Anxiety Inventory:
Outcome Questionnaire 45:
Short Form 36 Health Survey:
Revised Dyadic Adjustment Scale:
Family Assessment Device:
Strengths-Difficulties Questionnaire.
12 months post termination No
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