NCT01796223

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2012

Longer than P75 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

December 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 21, 2013

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

September 5, 2018

Status Verified

August 1, 2018

Enrollment Period

4.5 years

First QC Date

February 19, 2013

Last Update Submit

August 31, 2018

Conditions

Keywords

Community mental health servicesPsychotherapyPhysician-Patient RelationsNorway

Outcome Measures

Primary Outcomes (1)

  • Health care utilization

    Referral- and drop-out rate

    12 months

Secondary Outcomes (6)

  • Symptom level

    T 0 (baseline) and T4 (6 months, end of treatment)

  • Patient satisfaction

    T0, T2 (2 months), T4 (6 months, end of treatment)

  • Level of functioning

    T1 (1 hour start of treatment) and T4 (6 months or end of treatment)

  • Preferences for involvement in decision making

    T0, T2 (2 months) and T3 (3 months)

  • Patient Activation Measure

    T0, T1 (1 hour start of treatment), T3 (3 months) and T4 (6 months)

  • +1 more secondary outcomes

Other Outcomes (1)

  • Use of health services

    12 months

Study Arms (2)

Feedback

EXPERIMENTAL

Feedback system included in psychotherapy

Behavioral: Feedback

control

ACTIVE COMPARATOR

Psychotherapy as usual

Behavioral: Control

Interventions

FeedbackBEHAVIORAL

The Partners for Change Outcome Management System, administered at the beginning and ending of every therapy session.

Also known as: PCOMS, KOR (Norwegian)
Feedback
ControlBEHAVIORAL
control

Eligibility Criteria

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

You may qualify if:

  • Referred for treatment of mental disorder(s)

You may not qualify if:

  • Psychiatric emergency
  • Poor/no understanding of Norwegian language
  • Lack of ability to execute the practical procedures required for the project

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tiller Distriktspsykiatriske Senter

Trondheim, Norway

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • Olav M Linaker, MD, PhD

    Norwegian University of Science and Technology

    STUDY CHAIR
  • Mariela M Lara, MA

    National Taiwan Normal University

    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 19, 2013

First Posted

February 21, 2013

Study Start

December 1, 2012

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

September 5, 2018

Record last verified: 2018-08

Locations