Effects of Systematic Patient Feedback on Therapy Outcome

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by Norwegian University of Science and Technology
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
First received: February 19, 2013
Last updated: May 10, 2016
Last verified: May 2016
The aim of this study is to evaluate the effects of a feedback-system in psychotherapy on adult out-patients at a community mental health centre. It is hypothesized that the intervention will lead to more effective treatment, decreasing treatment dropout as well as improving patient-therapist relationship and patient activation in treatment.

Condition Intervention
Mental Disorders
Behavioral: Feedback
Behavioral: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Systematic Patient Feedback on Therapy Outcome and Dropout: A Randomized Controlled Study on Adult Out-patients at a Community Mental Health Centre.

Resource links provided by NLM:

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Health care utilization [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Referral- and drop-out rate

Secondary Outcome Measures:
  • Symptom level [ Time Frame: T 0 (baseline) and T4 (6 months, end of treatment) ] [ Designated as safety issue: No ]
    Outcome Rating Scale and BASIS 32 and WHO-5

  • Patient satisfaction [ Time Frame: T0, T2 (2 months), T4 (6 months, end of treatment) ] [ Designated as safety issue: No ]
    Client Satisfaction Questionnaire (CSQ-8; Attkinson & Zwick, 1982)

  • Level of functioning [ Time Frame: T1 (1 hour start of treament) and T4 (6 months or end of treatment) ] [ Designated as safety issue: No ]
    Global Assessment of Functioning (GAF; Hall, 1995)

  • Preferences for involvement in decision making [ Time Frame: T0, T2 (2 months) and T3 (3 months) ] [ Designated as safety issue: No ]
    Modified Control Preferences Scale (6 items)

  • Patient Activation Measure [ Time Frame: T0, T1 (1 hour start of treament), T3 (3 months) and T4 (6 months) ] [ Designated as safety issue: No ]
    Patient Activation Measure Mental Health Questionnaire (13 items)

  • Alliance [ Time Frame: T1 (1 hour start of treament), T2 (2 months ] [ Designated as safety issue: No ]
    Working Alliance Inventory (WAI-S)

Other Outcome Measures:
  • Use of health services [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Number of visits at general practitioner or other health services

Estimated Enrollment: 170
Study Start Date: December 2012
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Feedback
Feedback system included in psychotherapy
Behavioral: Feedback
The Partners for Change Outcome Management System, administered at the beginning and ending of every therapy session.
Other Names:
  • KOR (Norwegian)
Active Comparator: control
Psychotherapy as usual
Behavioral: Control


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

The aim is to include a total of 128 patients.

Inclusion Criteria:

  • Referred for treatment of mental disorder(s)

Exclusion Criteria:

  • Psychiatric emergency
  • Poor/no understanding of Norwegian language
  • Lack of ability to execute the practical procedures required for the project
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01796223

Contact: John Morten Koksvik, MD 0047 73 86 40 00 john.morten.koksvik@stolav.no
Contact: Mariela Lara 0047 73 86 40 00 mariela.lara@stolav.no

Tiller Distriktspsykiatriske Senter Recruiting
Trondheim, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
Study Chair: Olav M Linaker, MD, PhD Norwegian University of Science and Technology
Principal Investigator: Mariela M Lara, MA NTNU
  More Information

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01796223     History of Changes
Other Study ID Numbers: 2011/1271  2011/1271 
Study First Received: February 19, 2013
Last Updated: May 10, 2016
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Norwegian University of Science and Technology:
Community mental health services
Physician-Patient Relations

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders

ClinicalTrials.gov processed this record on May 23, 2016