Mental DisordersNCT01796223
Effects of Systematic Patient Feedback on Therapy Outcome
A study testing Feedback in people with Mental Disorders, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Disorders
- What is being tested?
- Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteNorway
- Study dates
- Dec 2012to 1 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Referred for treatment of mental disorder(s)
Who cannot join
- Psychiatric emergency
- Poor/no understanding of Norwegian language
- Lack of ability to execute the practical procedures required for the project
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Mental Disorders
- Being tested
- Feedback, Control
- Keywords
- Community mental health services, Psychotherapy, Physician-Patient Relations, Norway
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FeedbackBehavioural
Also called PCOMS, KOR (Norwegian)
The Partners for Change Outcome Management System, administered at the beginning and ending of every therapy session.
ControlBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Feedback | Experimental | Feedback system included in psychotherapy Receives: Behavioral: Feedback |
| control | Active comparator | Psychotherapy as usual Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health care utilization
Referral- and drop-out rate
Measured: 12 months
Secondary outcomes (6)
Symptom level
Outcome Rating Scale and BASIS 32 and WHO-5
Measured: T 0 (baseline) and T4 (6 months, end of treatment)
Patient satisfaction
Client Satisfaction Questionnaire (CSQ-8; Attkinson \& Zwick, 1982)
Measured: T0, T2 (2 months), T4 (6 months, end of treatment)
Level of functioning
Global Assessment of Functioning (GAF; Hall, 1995)
Measured: T1 (1 hour start of treatment) and T4 (6 months or end of treatment)
Preferences for involvement in decision making
Modified Control Preferences Scale (6 items)
Measured: T0, T2 (2 months) and T3 (3 months)
Patient Activation Measure
Patient Activation Measure Mental Health Questionnaire (13 items)
Measured: T0, T1 (1 hour start of treatment), T3 (3 months) and T4 (6 months)
Alliance
Working Alliance Inventory (WAI-S)
Measured: T1 (1 hour start of treatment), T2 (2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2013 (estimated)
- Study startDec 2012
- Primary completion1 Jun 2017
- Study completion1 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mental DisordersStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olav M Linaker, MD, PhD, Study chair, Norwegian University of Science and TechnologyMariela M Lara, MA, Principal investigator, National Taiwan Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01796223
- Sponsor's protocol ID
- 2011/1271
- Other IDs
- 2011/1271
- Status last verified
- Aug 2018
- First submitted
- 19 Feb 2013
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30113180Brattland 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.
PubMed 30702322
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01796223
- Acronym / sponsor ID
- 2011/1271
- Conditions
- Mental Disorders
- Keywords
- Community mental health services, Psychotherapy, Physician-Patient Relations, Norway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Dec 2012 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 21 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Feedback | Experimental | Behavioral: FeedbackFeedback system included in psychotherapy |
| control | Active comparator | Behavioral: ControlPsychotherapy as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Referred for treatment of mental disorder(s)
Key exclusion criteria (3 listed)
- Psychiatric emergency
- Poor/no understanding of Norwegian language
- Lack of ability to execute the practical procedures required for the project
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FeedbackAlso: PCOMS, KOR (Norwegian)The Partners for Change Outcome Management System, administered at the beginning and ending of every therapy session. | Behavioural | Feedback |
| Control | Behavioural | control |
Primary outcome
Health care utilization
Time frame: 12 months
Referral- and drop-out rate
6 secondary outcomes
Symptom level
Time frame: T 0 (baseline) and T4 (6 months, end of treatment)
Patient satisfaction
Time frame: T0, T2 (2 months), T4 (6 months, end of treatment)
Level of functioning
Time frame: T1 (1 hour start of treatment) and T4 (6 months or end of treatment)
Preferences for involvement in decision making
Time frame: T0, T2 (2 months) and T3 (3 months)
Patient Activation Measure
Time frame: T0, T1 (1 hour start of treatment), T3 (3 months) and T4 (6 months)
Alliance
Time frame: T1 (1 hour start of treatment), T2 (2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
- Results publication: PubMed 30113180Brattland 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.
- Derived from this study: PubMed 30702322Brattland 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olav M Linaker, MD, PhD study chair
Norwegian University of Science and Technology
Mariela M Lara, MA principal investigator
National Taiwan Normal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feedback in people with Mental Disorders, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health care utilization (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01796223, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2018.