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Effects of Systematic Patient Feedback on Therapy Outcome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01796223
First Posted: February 21, 2013
Last Update Posted: June 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Norwegian University of Science and Technology
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]
    Referral- and drop-out rate


Secondary Outcome Measures:
  • Symptom level [ Time Frame: T 0 (baseline) and T4 (6 months, end of treatment) ]
    Outcome Rating Scale and BASIS 32 and WHO-5

  • Patient satisfaction [ Time Frame: T0, T2 (2 months), T4 (6 months, end of treatment) ]
    Client Satisfaction Questionnaire (CSQ-8; Attkinson & Zwick, 1982)

  • Level of functioning [ Time Frame: T1 (1 hour start of treatment) and T4 (6 months or end of treatment) ]
    Global Assessment of Functioning (GAF; Hall, 1995)

  • Preferences for involvement in decision making [ Time Frame: T0, T2 (2 months) and T3 (3 months) ]
    Modified Control Preferences Scale (6 items)

  • Patient Activation Measure [ Time Frame: T0, T1 (1 hour start of treatment), T3 (3 months) and T4 (6 months) ]
    Patient Activation Measure Mental Health Questionnaire (13 items)

  • Alliance [ Time Frame: T1 (1 hour start of treatment), T2 (2 months ]
    Working Alliance Inventory (WAI-S)


Other Outcome Measures:
  • Use of health services [ Time Frame: 12 months ]
    Number of visits at general practitioner or other health services


Enrollment: 170
Actual Study Start Date: December 2012
Study Completion Date: June 1, 2017
Primary Completion Date: June 1, 2017 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01796223


Locations
Norway
Tiller Distriktspsykiatriske Senter
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

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01796223     History of Changes
Other Study ID Numbers: 2011/1271
2011/1271 ( Registry Identifier: Regional committee for medical research ethics )
First Submitted: February 19, 2013
First Posted: February 21, 2013
Last Update Posted: June 14, 2017
Last Verified: June 2017

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 Spectrum and Other Psychotic Disorders