Individual Psychiatric DisorderNCT02023736
Assessing Psychotherapy Outcome With Feedback
A study testing Systemic Therapy Inventory of Change (STIC) and Treatment as Usual in people with Individual Psychiatric Disorder and Couple Dysfunction, run by The Family Institute at Northwestern University at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Individual Psychiatric Disorder, Couple Dysfunction, Family Dysfunction
- What is being tested?
- Systemic Therapy Inventory of Change (STIC) and Treatment as Usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2013to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites, 4 recruiting
- Recruiting
Community Counseling Centers of Chicago
Chicago, Illinois, 60640
- Recruiting
Jewish Child and Family Services
Chicago, Illinois, 60645
- Recruiting
Catholic Charities
Chicago, Illinois, 60654
- Recruiting
The Family Institute at Northwestern University
Evanston, Illinois, 60201
William Pinsof, Ph.D.
About this study
Official title: Assessing Psychotherapy Outcome in Treatment as Usual Versus Treatment as Usual With the STIC Feedback System
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.
- Being tested
- Systemic Therapy Inventory of Change (STIC), Treatment as Usual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systemic Therapy Inventory of Change (STIC)Other
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 UsualOther
Clients receive psychotherapy treatment as planned and implemented by their psychotherapists. Exact type of treatment varies by therapist and according to client need.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual | Active comparator | Patients in the Treatment as Usual condition receive the same psychotherapy treatment as they would were they not enrolled in the study. Receives: Other: Treatment as Usual |
| Treatment as Usual with the STIC (TAU + STIC) | Experimental | Patients in the TAU + STIC condition receive the treatment that they normally would from their therapist, but with the addition of the STIC measurement and feedback system. Receives: Other: Systemic Therapy Inventory of Change (STIC); Other: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Secondary outcomes (2)
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.
Measured: 6 months post termination
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.
Measured: 12 months post termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionJan 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Individual Psychiatric DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Family Institute at Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- The Chicago Community Trust, Jewish Child and Family Services, Catholic Charities, Community Counseling Centers of Chicago
- Responsible party
- Sponsor
- Investigators
- William Pinsof, Ph.D., Principal investigator, The Family Institute at Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02023736
- Sponsor's protocol ID
- TFI-001
- Status last verified
- Aug 2016
- First submitted
- 19 Dec 2013
- Last updated
- 9 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Psychotherapy Outcome in Treatment as Usual Versus Treatment as Usual With the STIC Feedback System
- ClinicalTrials.gov ID
- NCT02023736
- Acronym / sponsor ID
- TFI-001
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- The Family Institute at Northwestern UniversityUniversity, hospital or other
- Collaborators
- The Chicago Community Trust, Jewish Child and Family Services, Catholic Charities, Community Counseling Centers of Chicago
- Study start
- Dec 2013
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 30 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual | Active comparator | Other: Treatment as UsualPatients in the Treatment as Usual condition receive the same psychotherapy treatment as they would were they not enrolled in the study. |
| Treatment as Usual with the STIC (TAU + STIC) | Experimental | Other: Systemic Therapy Inventory of Change (STIC), Other: Treatment as UsualPatients in the TAU + STIC condition receive the treatment that they normally would from their therapist, but with the addition of the STIC measurement and feedback system. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Treatment as Usual with the STIC (TAU + STIC) |
| Treatment as UsualClients receive psychotherapy treatment as planned and implemented by their psychotherapists. Exact type of treatment varies by therapist and according to client need. | Other | Treatment as Usual, Treatment as Usual with the STIC (TAU + STIC) |
Primary outcome
Change in mental health symptoms at termination
Time frame: 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.
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.
2 secondary outcomes
Change in mental health symptoms at 6-month follow up
Time frame: 6 months post termination
Change in mental health symptoms at 12-month follow-up
Time frame: 12 months post termination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Pinsof, Ph.D. principal investigator
The Family Institute at Northwestern University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systemic Therapy Inventory of Change (STIC) and Treatment as Usual in people with Individual Psychiatric Disorder and Couple Dysfunction, run by The Family Institute at Northwestern University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jacob Z Goldsmith, Ph.D. (847 733 4300 ext. 650, jgoldsmith2@family-institute.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mental health symptoms at termination (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2016.