NCT01083225

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2010

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 9, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

August 19, 2015

Status Verified

August 1, 2015

Enrollment Period

2.2 years

First QC Date

February 23, 2010

Last Update Submit

August 18, 2015

Conditions

Outcome Measures

Primary Outcomes (3)

  • Mental health symptom score (Basis-32)

    Baseline, 6 weeks, 6 months & 12 months

  • Patient activation (Patient Activation Measure)

    Baseline, 6 weeks, 6 months & 12 months

  • Alliance (Inpatient treatment alliance scale)

    Baseline, 6 weeks, 6 months & 12 months

Secondary Outcomes (5)

  • Patient satisfaction (Client Satisfaction Questionnaire)

    Baseline, 6 weeks, 6 months & 12 months

  • Quality of life (Short form 12)

    Baseline, 6 weeks, 6 months & 12 months

  • Evaluation of problems (Outcome rating scale)

    Baseline, 6 weeks, 6 months & 12 months

  • Evaluation of consultations (Session Rating Scale)

    Baseline, 6 weeks, 6 months & 12 months

  • Evaluation of involvement

    Baseline, 6 weeks, 6 months & 12 months

Study Arms (2)

Client feedback

EXPERIMENTAL
Behavioral: Client feedback

Treatment as usual

ACTIVE COMPARATOR
Behavioral: Treatment as usual

Interventions

Client feedbackBEHAVIORAL

Client feedback during consultations using ORS (Outcome rating scale) and SRS (Session rating scale).

Client feedback

Treatment as usual, consultations

Treatment as usual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 18 years of age.

You may not qualify if:

  • Not able to complete the questionnaires.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Olavs Hospital, Nidaros Mental Health Center

Trondheim, Norway

Location

Related Publications (1)

  • Rise MB, Eriksen L, Grimstad H, Steinsbekk A. The long-term effect on mental health symptoms and patient activation of using patient feedback scales in mental health out-patient treatment. A randomised controlled trial. Patient Educ Couns. 2016 Jan;99(1):164-8. doi: 10.1016/j.pec.2015.07.016. Epub 2015 Jul 19.

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Aslak Steinsbekk, PhD

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2010

First Posted

March 9, 2010

Study Start

January 1, 2010

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

August 19, 2015

Record last verified: 2015-08

Locations