Effect of Patient Participation in Mental Health Care

August 18, 2015 updated by: Norwegian University of Science and Technology

Randomised Controlled Trial on the Effect of Individual User Involvement in a Mental Health Center

The purpose of this study is to evaluate the effect of individual user involvement in an outpatient mental health center. The intervention consists of patients completing a self-report symptom and problem questionnaire and reviewing it with a clinician.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway
        • St. Olavs Hospital, Nidaros Mental Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Over 18 years of age.

Exclusion Criteria:

  • Not able to complete the questionnaires.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment as usual
Behavioral: Treatment as usual
Treatment as usual, consultations
Experimental: Client feedback
Behavioral: Client feedback
Client feedback during consultations using ORS (Outcome rating scale) and SRS (Session rating scale).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mental health symptom score (Basis-32)
Time Frame: Baseline, 6 weeks, 6 months & 12 months
Baseline, 6 weeks, 6 months & 12 months
Patient activation (Patient Activation Measure)
Time Frame: Baseline, 6 weeks, 6 months & 12 months
Baseline, 6 weeks, 6 months & 12 months
Alliance (Inpatient treatment alliance scale)
Time Frame: Baseline, 6 weeks, 6 months & 12 months
Baseline, 6 weeks, 6 months & 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient satisfaction (Client Satisfaction Questionnaire)
Time Frame: Baseline, 6 weeks, 6 months & 12 months
Baseline, 6 weeks, 6 months & 12 months
Quality of life (Short form 12)
Time Frame: Baseline, 6 weeks, 6 months & 12 months
Baseline, 6 weeks, 6 months & 12 months
Evaluation of problems (Outcome rating scale)
Time Frame: Baseline, 6 weeks, 6 months & 12 months
Baseline, 6 weeks, 6 months & 12 months
Evaluation of consultations (Session Rating Scale)
Time Frame: Baseline, 6 weeks, 6 months & 12 months
Baseline, 6 weeks, 6 months & 12 months
Evaluation of involvement
Time Frame: Baseline, 6 weeks, 6 months & 12 months
Baseline, 6 weeks, 6 months & 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

The Research Council of Norway
Norwegian Foundation for Health and Rehabilitation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

February 23, 2010

First Submitted That Met QC Criteria

March 8, 2010

First Posted (Estimate)

March 9, 2010

Study Record Updates

Last Update Posted (Estimate)

August 19, 2015

Last Update Submitted That Met QC Criteria

August 18, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 2008/2/0325

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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