Effects of Systematic Patient Feedback on Therapy Outcome
Primary Purpose
Mental Disorders
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Feedback
Control
Sponsored by
About this trial
This is an interventional treatment trial for Mental Disorders focused on measuring Community mental health services, Psychotherapy, Physician-Patient Relations, Norway
Eligibility 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
Sites / Locations
- Tiller Distriktspsykiatriske Senter
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Feedback
control
Arm Description
Feedback system included in psychotherapy
Psychotherapy as usual
Outcomes
Primary Outcome Measures
Health care utilization
Referral- and drop-out rate
Secondary Outcome Measures
Symptom level
Outcome Rating Scale and BASIS 32 and WHO-5
Patient satisfaction
Client Satisfaction Questionnaire (CSQ-8; Attkinson & Zwick, 1982)
Level of functioning
Global Assessment of Functioning (GAF; Hall, 1995)
Preferences for involvement in decision making
Modified Control Preferences Scale (6 items)
Patient Activation Measure
Patient Activation Measure Mental Health Questionnaire (13 items)
Alliance
Working Alliance Inventory (WAI-S)
Full Information
NCT ID
NCT01796223
First Posted
February 19, 2013
Last Updated
August 31, 2018
Sponsor
Norwegian University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT01796223
Brief Title
Effects of Systematic Patient Feedback on Therapy Outcome
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
December 2012 (Actual)
Primary Completion Date
June 1, 2017 (Actual)
Study Completion Date
June 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorders
Keywords
Community mental health services, Psychotherapy, Physician-Patient Relations, Norway
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
170 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Feedback
Arm Type
Experimental
Arm Description
Feedback system included in psychotherapy
Arm Title
control
Arm Type
Active Comparator
Arm Description
Psychotherapy as usual
Intervention Type
Behavioral
Intervention Name(s)
Feedback
Other Intervention Name(s)
PCOMS, KOR (Norwegian)
Intervention Description
The Partners for Change Outcome Management System, administered at the beginning and ending of every therapy session.
Intervention Type
Behavioral
Intervention Name(s)
Control
Primary Outcome Measure Information:
Title
Health care utilization
Description
Referral- and drop-out rate
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Symptom level
Description
Outcome Rating Scale and BASIS 32 and WHO-5
Time Frame
T 0 (baseline) and T4 (6 months, end of treatment)
Title
Patient satisfaction
Description
Client Satisfaction Questionnaire (CSQ-8; Attkinson & Zwick, 1982)
Time Frame
T0, T2 (2 months), T4 (6 months, end of treatment)
Title
Level of functioning
Description
Global Assessment of Functioning (GAF; Hall, 1995)
Time Frame
T1 (1 hour start of treatment) and T4 (6 months or end of treatment)
Title
Preferences for involvement in decision making
Description
Modified Control Preferences Scale (6 items)
Time Frame
T0, T2 (2 months) and T3 (3 months)
Title
Patient Activation Measure
Description
Patient Activation Measure Mental Health Questionnaire (13 items)
Time Frame
T0, T1 (1 hour start of treatment), T3 (3 months) and T4 (6 months)
Title
Alliance
Description
Working Alliance Inventory (WAI-S)
Time Frame
T1 (1 hour start of treatment), T2 (2 months
Other Pre-specified Outcome Measures:
Title
Use of health services
Description
Number of visits at general practitioner or other health services
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olav M Linaker, MD, PhD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mariela M Lara, MA
Organizational Affiliation
National Taiwan Normal University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tiller Distriktspsykiatriske Senter
City
Trondheim
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
30113180
Citation
Brattland H, Koksvik JM, Burkeland O, Grawe RW, Klockner C, Linaker OM, Ryum T, Wampold B, Lara-Cabrera ML, Iversen VC. The effects of routine outcome monitoring (ROM) on therapy outcomes in the course of an implementation process: A randomized clinical trial. J Couns Psychol. 2018 Oct;65(5):641-652. doi: 10.1037/cou0000286. Epub 2018 Aug 16.
Results Reference
result
PubMed Identifier
30702322
Citation
Brattland H, Koksvik JM, Burkeland O, Klockner CA, Lara-Cabrera ML, Miller SD, Wampold B, Ryum T, Iversen VC. Does the working alliance mediate the effect of routine outcome monitoring (ROM) and alliance feedback on psychotherapy outcomes? A secondary analysis from a randomized clinical trial. J Couns Psychol. 2019 Mar;66(2):234-246. doi: 10.1037/cou0000320. Epub 2019 Jan 31.
Results Reference
derived
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Effects of Systematic Patient Feedback on Therapy Outcome
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