Mental HealthNCT01083225
Effect of Patient Participation in Mental Health Care
A study testing Client feedback and Treatment as usual in people with Mental Health, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Health
- What is being tested?
- Client feedback and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2010to Mar 2012
- 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
- Over 18 years of age.
Who cannot join
- Not able to complete the questionnaires.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Mental Health
- Being tested
- Client feedback, Treatment as usual
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Client feedbackBehavioural
Client feedback during consultations using ORS (Outcome rating scale) and SRS (Session rating scale).
Treatment as usualBehavioural
Treatment as usual, consultations
| Study group | Role | What they receive |
|---|---|---|
| Client feedback | Experimental | Not described Receives: Behavioral: Client feedback |
| Treatment as usual | Active comparator | Not described Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental health symptom score (Basis-32)
Measured: Baseline, 6 weeks, 6 months & 12 months
Patient activation (Patient Activation Measure)
Measured: Baseline, 6 weeks, 6 months & 12 months
Alliance (Inpatient treatment alliance scale)
Measured: Baseline, 6 weeks, 6 months & 12 months
Secondary outcomes (5)
Patient satisfaction (Client Satisfaction Questionnaire)
Measured: Baseline, 6 weeks, 6 months & 12 months
Quality of life (Short form 12)
Measured: Baseline, 6 weeks, 6 months & 12 months
Evaluation of problems (Outcome rating scale)
Measured: Baseline, 6 weeks, 6 months & 12 months
Evaluation of consultations (Session Rating Scale)
Measured: Baseline, 6 weeks, 6 months & 12 months
Evaluation of involvement
Measured: Baseline, 6 weeks, 6 months & 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2010 (estimated)
- Study startJan 2010
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Foundation for Health and Rehabilitation, The Research Council of Norway
- Responsible party
- Sponsor
- Investigators
- Aslak Steinsbekk, PhD, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01083225
- Sponsor's protocol ID
- 2008/2/0325
- Status last verified
- Aug 2015
- First submitted
- 23 Feb 2010
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26227577
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial on the Effect of Individual User Involvement in a Mental Health Center
- ClinicalTrials.gov ID
- NCT01083225
- Acronym / sponsor ID
- 2008/2/0325
- Conditions
- Mental Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Norwegian Foundation for Health and Rehabilitation, The Research Council of Norway
- Study start
- Jan 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 9 Mar 2010 (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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Client feedback | Experimental | Behavioral: Client feedback |
| Treatment as usual | Active comparator | Behavioral: Treatment 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)
- Over 18 years of age.
Key exclusion criteria (1 listed)
- Not able to complete the questionnaires.
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 |
|---|---|---|
| Client feedbackClient feedback during consultations using ORS (Outcome rating scale) and SRS (Session rating scale). | Behavioural | Client feedback |
| Treatment as usualTreatment as usual, consultations | Behavioural | Treatment as usual |
Primary outcome
Mental health symptom score (Basis-32)
Time frame: Baseline, 6 weeks, 6 months & 12 months
Patient activation (Patient Activation Measure)
Time frame: Baseline, 6 weeks, 6 months & 12 months
Alliance (Inpatient treatment alliance scale)
Time frame: Baseline, 6 weeks, 6 months & 12 months
5 secondary outcomes
Patient satisfaction (Client Satisfaction Questionnaire)
Time frame: Baseline, 6 weeks, 6 months & 12 months
Quality of life (Short form 12)
Time frame: Baseline, 6 weeks, 6 months & 12 months
Evaluation of problems (Outcome rating scale)
Time frame: Baseline, 6 weeks, 6 months & 12 months
Evaluation of consultations (Session Rating Scale)
Time frame: Baseline, 6 weeks, 6 months & 12 months
Evaluation of involvement
Time frame: Baseline, 6 weeks, 6 months & 12 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 19 Aug 2015.
- Results publication: PubMed 26227577Rise 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.
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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.
Aslak Steinsbekk, PhD principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Client feedback and Treatment as usual in people with Mental Health, 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 1 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 19 Aug 2015. 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?
Mental health symptom score (Basis-32) (time frame: Baseline, 6 weeks, 6 months & 12 months). The study lists 3 primary outcomes in all. 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 NCT01083225, which also lists 1 linked publication.
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 19 Aug 2015.