- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01873742
The STIC Norway RCT Study: Using Feedback in Psychotherapy. (STICNorway)
April 22, 2020 updated by: Terje Tilden, PhD, Modum Bad
The STIC Online Feedback System in Psychotherapy Process-outcome Research: A Multi-site, Multi-modality, International RCT-study.
Feedback in psychotherapy involves clients monitoring therapy process and progress, and on a frequent basis clients register these data into online questionnaires.
These data are then fed back to the therapist, hence informing about the process and progress in therapy.
This information can be shared with the client, something that may enhance the client involvement in evaluating and planning of the therapy.
The same data can be used for research purpose.
This randomized controlled multicenter study within Norwegian couple and family contexts will explore the effects of feedback in natural settings, and it collaborates closely with a similar American study in Chicago/Evanston, Ill.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The improvement rate in psychotherapy is generally regarded as 50%, while 10% of clients deteriorate after therapy.
This indicates a potential for improvement.
Research shows that in therapies with the lack of progress, the clients rarely express dissatisfaction about progress to their therapists, and parallel, these therapists consider the therapies to proceed in the right direction.
There is therefore a need for more knowledge about (a) how to obtain reliable information about the therapy progress and process monitored frequently during the course of therapy, and (b) that this information is fed back to the therapist and the client so that they (c) jointly can evaluate and adjust the aims and means for improving the therapy, something that may (d) enable them to test more appropriate approaches.
This clinical practice should also enhance the client collaboration and empowerment in therapy, hopefully leading to higher recovery rate, shorter treatments, and reduced drop-out.
To date, there is limited research on whether and how the use of feedback can contribute to improved outcomes.
Such research is especially lacking in couple and family therapy.
In a 3-year Norwegian pilot project at the Center for Family and relationships, Modum Bad, Department of Child and Adolescent Mental Health, Sørlandet Sykehus, and at Ålesund family counseling office, the online-based feedback system STIC (Systemic Therapy Inventory of Change) has been implemented and tested.
The clinical experience is positive, and the system is considered suitable.
This project has evolved parallel to a similar project at the Family Institute at Northwestern University, Evanston, Ill., supervised by the founder of the STIC system, professor William M. Pinsof.
The project now enters a new phase by conducting a randomized, controlled trial (RCT) at three Norwegian couple- and family therapy sites in collaboration with five American psychotherapy sites to investigate whether the use of ongoing feedback is associated to more effective therapy compared with therapy without use of feedback.
Study Type
Interventional
Enrollment (Actual)
328
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Buskerud
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Drammen, Buskerud, Norway, 3000
- Drammen - Kongsberg family agency
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Vikersund, Buskerud, Norway, 3370
- Center for family and relationship, Modum Bad
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Vest Agder
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Kristiansand, Vest Agder, Norway, 4604
- ABUP, Sørlandet sykehus
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 70 years (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- individuals,
- couples,
- families in Norwegian couple- and family therapy contexts
Exclusion Criteria:
- psychosis,
- current drug and alcohol abuse,
- violent and threatening behavior,
- not enable to understand Norwegian or English language.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: The use of STIC feedback system
This will constitute the experimental condition, using of STIC feedback system.
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This condition includes the use of the STIC feedback system.
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EXPERIMENTAL: Treatment as usual
This condition will not include the use of the STIC feedback system.
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This condition includes the use of the STIC feedback system.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Beck Depression Inventory II
Time Frame: The BDI was completed at the start and end of treatment. In this study the treatment length varied from two to 22 sessions.
|
The Beck Depression Inventory (BDI-II - Beck et al., 1995a) is a widely used 21-item self-report questionnaire assessing cognitive, affective, motivational, and physiological symptoms of depression and variation over time.
Items are scored on a scale from 0 to 3 and the sum-score expressed the depth of the depression, graded from no clinical depression (0-9), through mild (10-19), moderate (20-29) and severe depression (30-63).
The BDI shows adequate psychometric properties (Beck et al., 1995b).
|
The BDI was completed at the start and end of treatment. In this study the treatment length varied from two to 22 sessions.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: KariAnne Vrabel, PhD, Modum Bad Research Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Pinsof WM, Zinbarg RE, Lebow JL, Knobloch-Fedders LM, Durbin E, Chambers A, Latta T, Karam E, Goldsmith J, Friedman G. Laying the foundation for progress research in family, couple, and individual therapy: the development and psychometric features of the initial systemic therapy inventory of change. Psychother Res. 2009 Mar;19(2):143-56. doi: 10.1080/10503300802669973.
- Tilden T, Johnson SU, Hoffart A, Zahl-Olsen R, Wampold BE, Ulvenes P, Haland AT. Alliance predicting progress in couple therapy. Psychotherapy (Chic). 2021 Sep;58(3):391-400. doi: 10.1037/pst0000355. Epub 2021 Feb 4.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 1, 2013
Primary Completion (ACTUAL)
October 15, 2016
Study Completion (ACTUAL)
October 15, 2016
Study Registration Dates
First Submitted
February 21, 2013
First Submitted That Met QC Criteria
June 7, 2013
First Posted (ESTIMATE)
June 10, 2013
Study Record Updates
Last Update Posted (ACTUAL)
May 4, 2020
Last Update Submitted That Met QC Criteria
April 22, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1-Tilden
- 2012/2/0275 (OTHER: Rådet for psykisk helse, Norway)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Psychological Feedback
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Western Norway University of Applied SciencesUniversity of MalagaCompleted
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University of TrierGerman Research FoundationCompletedFeedback, PsychologicalGermany
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University of BergamoUniversity of Palermo; University of Sheffield; University of Ottawa; Leiden University and other collaboratorsRecruitingFeedback, PsychologicalItaly
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Istanbul University - CerrahpasaCompleted
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Weill Medical College of Cornell UniversityNational Cancer Institute (NCI); National Institutes of Health (NIH)WithdrawnCancer | Psychological Feedback | Liquid TumorUnited States
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Ginger YangUniversity of Iowa; Ohio State University; University of NebraskaRecruitingCommunication | Recidivism | Drive | Feedback, PsychologicalUnited States
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Ginger YangUniversity of Iowa; Ohio State University; University of NebraskaCompletedCommunication | Recidivism | Drive | Feedback, PsychologicalUnited States
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Sahmyook UniversityCompletedSpinal Curvatures | Feedback, Psychological | Sitting PositionKorea, Republic of
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National Taiwan University HospitalNational Taiwan University Hospital, Yun-Lin BranchCompletedPanic Disorder | Feedback, PsychologicalTaiwan
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Equa HealthNational Institute of Mental Health (NIMH); Worcester Polytechnic InstituteCompletedPsychological Distress | Develop a Respiration Biosignal Feedback Algorithm | Utilize Respiration Algorithm to Predict Mindfulness SkillsUnited States
Clinical Trials on STIC feedback system
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The Family Institute at Northwestern UniversityThe Chicago Community Trust; Jewish Child and Family Services; Catholic Charities and other collaboratorsUnknownFamily Dysfunction | Individual Psychiatric Disorder | Couple DysfunctionUnited States
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University of PittsburghUnited States Department of Defense; Georgia Institute of TechnologyCompletedPressure Ulcer | Pressure Injury | Pressure Ulcer, ButtockUnited States
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University of AarhusCompleted
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Molex Ventures LLCUniversity of VirginiaSuspended
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Northwestern UniversityNational Cancer Institute (NCI)RecruitingSarcoma | Cervical Cancer | Ovarian Cancer | Fallopian Tube Cancer | Vulvar Cancer | Endometrial Cancer | Vaginal Cancer | Hereditary Breast/Ovarian Cancer (brca1, brca2) | Uterine LeiomyomataUnited States
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Hadassah Medical OrganizationTel Aviv UniversityCompletedUnilateral Transradial AmputationIsrael
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Yale UniversityNational Institute on Drug Abuse (NIDA); National Institutes of Health (NIH); University of Connecticut and other collaboratorsCompleted
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University Medicine GreifswaldDeutsche Krebshilfe e.V., Bonn (Germany)UnknownSmoking | Passive Smoking | Exposure to Environmental SmokeGermany
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University of California, San DiegoNational Institute of Mental Health (NIMH); Gilead Sciences; Proteus Digital...Active, not recruiting
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Ottawa Hospital Research InstituteCompletedHypothermia | Surgical Site InfectionsCanada