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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
328

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Norway
    • Buskerud
      • Drammen, Buskerud, Norway, 3000
        • Drammen - Kongsberg family agency
      • Vikersund, Buskerud, Norway, 3370
        • Center for family and relationship, Modum Bad
    • Vest Agder
      • Kristiansand, Vest Agder, Norway, 4604
        • ABUP, Sørlandet sykehus

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: The use of STIC feedback system
This will constitute the experimental condition, using of STIC feedback system.
Other: STIC feedback system
This condition includes the use of the STIC feedback system.
EXPERIMENTAL: Treatment as usual
This condition will not include the use of the STIC feedback system.
Other: STIC feedback system
This condition includes the use of the STIC feedback system.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Modum Bad

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Stiftelsen Helse og Rehabilitering

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 15, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 15, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 21, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 10, 2013

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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