Effects of Systematic Patient Feedback on Therapy Outcome

This study is currently recruiting participants.
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
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 April 23, 2014