Effects of Systematic Patient Feedback on Therapy Outcome

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Norwegian University of Science and Technology
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01796223
First received: February 19, 2013
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

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 (Week 1,start of treatment) 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: T1 (1 month), 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 (Week, 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 and T3 ] [ Designated as safety issue: No ]
    Modified Control Preferences Scale (6 items)

  • Patient Activation Measure [ Time Frame: T0, T1, T3 and T4 ] [ Designated as safety issue: No ]
    Patient Activation Measure Mental Health Questionnaire (13 items)


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: 120
Study Start Date: December 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (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:
  • PCOMS
  • KOR (Norwegian)
Active Comparator: control
Psychotherapy as usual
Behavioral: Control

  Eligibility

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

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

Contacts
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

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

No publications provided

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: April 16, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics

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

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on July 20, 2014