Mental DisordersNCT00967265
Introduction Seminar About Patient Participation and Treatment Options for Psychiatric Patients on Waiting List
A study testing Introduction seminar in people with Mental Disorders, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
Patient participation is a central concept in Norwegian health policy. It is mandatory in hospitals and emphasised as one of the most prioritised areas by the Government. Studies from Norway have repeatedly found that patients who seek help in community mental health centres ("DPS") are dissatisfied with the… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mental Disorders
- What is being tested?
- Introduction seminar
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteNorway
- Study dates
- Jun 2009to Jul 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 18 years referred for out patient treatment who get a guarantee of starting treatment between 2 and 6 months will be included.
Who cannot join
- patients with a guarantee of starting treatment in less than two months and
- patients who do not understand the consequences of taking part in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Introduction Seminar About Patient Participation and Treatment Options for Patients on Waiting List in a Community Mental Health Centre - Development, Effect, Experiences and Costs
Patient participation is a central concept in Norwegian health policy. It is mandatory in hospitals and emphasised as one of the most prioritised areas by the Government. Studies from Norway have repeatedly found that patients who seek help in community mental health centres ("DPS") are dissatisfied with the information they receive and about their possibility for real influence in their treatment.
One way to improve individual patient participation might be to give patients information before they start their treatment. This can be done as group based patient education to reduce the resources needed. Furthermore, as there are waiting lists for treatment, such introduction seminars could be held while patients are waiting to use this time in a meaningful way.
The present study therefore aims at testing the effect of an introduction seminar for patients on waiting list in a community mental health centre.
- Conditions
- Mental Disorders
- Being tested
- Introduction seminar, Usual care
- Keywords
- Introduction seminar, Psychoeducation, Waiting list, Patient participation, Mental disorders
- Medical subject headings
- Mental Disorders, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Introduction seminarBehavioural
Also called psychoeducation
The seminar will be held over two half days, each lasting 2.5 hours. Up to 30 patients can participate in each seminar. The details of the content of the program will be developed based on study one. The preliminarily plans are to give general information about the community mental health centre, the available treatment options and patients rights by presentations from health personnel and user representatives. At the end of each day, the patients will be divided into small groups mentored by health personnel were they can discuss the presentations and ask questions. In the breaks, literature and other type of information for patients will be on display. All participants will get a folder with details of the program and leaflets from patient organisations and governmental agencies.
Usual careOther
Usual care
| Study group | Role | What they receive |
|---|---|---|
| Introduction seminar | Experimental | Psychoeducation for patients on waiting list Receives: Behavioral: Introduction seminar |
| Usual care | Active comparator | Usual care Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavior and symptoms
Behavior and Symptom Identification Scale (BASIS-32)
Measured: 12 months
knowledge on treatment preference
Measured: 1 month
patient activation (coping)
measured with Patient Activation Measure (PAM)
Measured: 4 months
Secondary outcomes (7)
Client satisfaction
Satisfaction measured with Client Satisfaction Questionnaire (CSQ-8)
Measured: Baseline, 4 and 12 months
Perceived participation
Perceived participation measured with Perception of care (PoC)
Measured: Baseline, 4 and 12 months
Psychiatric Out-Patient Experiences
Psychiatric Out-Patient Experiences Questionnaire (POPEQ)
Measured: Baseline, 4 and 12 months
Quality of Life
WHO-5
Measured: Baseline, 4 and 12 months
motivation for treatment
motivation for treatment (questions)
Measured: Baseline, 1 and 4 months
costs
data on health care use, sick leave, medication and other direct and indirect costs will be collected
Measured: Baseline, 1, 4 and 12 months
Knowledge
measured using a self developed questionnaire
Measured: Baseline, 1, 4 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2009 (estimated)
- Study startJun 2009
- Primary completionJun 2011
- Study completionJul 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 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
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Nord-Trøndelag HF
- Responsible party
- Sponsor
- Investigators
- Aslak Steinsbekk, PhD, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00967265
- Sponsor's protocol ID
- Introduction seminar
- Status last verified
- Aug 2018
- First submitted
- 26 Aug 2009
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Koksvik JM, Linaker OM, Grawe RW, Bjorngaard JH, Lara-Cabrera ML. The effects of a pretreatment educational group programme on mental health treatment outcomes: a randomized controlled trial. BMC Health Serv Res. 2018 Aug 29;18(1):665. doi: 10.1186/s12913-018-3466-2.
PubMed 30157839
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
- Introduction Seminar About Patient Participation and Treatment Options for Patients on Waiting List in a Community Mental Health Centre - Development, Effect, Experiences and Costs
- ClinicalTrials.gov ID
- NCT00967265
- Acronym / sponsor ID
- Introduction seminar
- Conditions
- Mental Disorders
- Keywords
- Introduction seminar, Psychoeducation, Waiting list, Patient participation, Mental disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Helse Nord-Trøndelag HF
- Study start
- Jun 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 27 Aug 2009 (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.
Patient participation is a central concept in Norwegian health policy. It is mandatory in hospitals and emphasised as one of the most prioritised areas by the Government. Studies from Norway have repeatedly found that patients who seek help in community mental health centres ("DPS") are dissatisfied with the information they receive and about their possibility for real influence in their treatment.
One way to improve individual patient participation might be to give patients information before they start their treatment. This can be done as group based patient education to reduce the resources needed. Furthermore, as there are waiting lists for treatment, such introduction seminars could be held while patients are waiting to use this time in a meaningful way.
The present study therefore aims at testing the effect of an introduction seminar for patients on waiting list in a community mental health centre.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Introduction seminar | Experimental | Behavioral: Introduction seminarPsychoeducation for patients on waiting list |
| Usual care | Active comparator | Other: Usual careUsual care |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients older than 18 years referred for out patient treatment who get a guarantee of starting treatment between 2 and 6 months will be included.
Key exclusion criteria (2 listed)
- patients with a guarantee of starting treatment in less than two months and
- patients who do not understand the consequences of taking part in the study
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 |
|---|---|---|
| Introduction seminarAlso: psychoeducationThe seminar will be held over two half days, each lasting 2.5 hours. Up to 30 patients can participate in each seminar. The details of the content of the program will be developed based on study one. The preliminarily plans are to give general information about the community mental health centre, the available treatment options and patients rights by presentations from health personnel and user representatives. At the end of each day, the patients will be divided into small groups mentored by health personnel were they can discuss the presentations and ask questions. In the breaks, literature and other type of information for patients will be on display. All participants will get a folder with details of the program and leaflets from patient organisations and governmental agencies. | Behavioural | Introduction seminar |
| Usual careUsual care | Other | Usual care |
Primary outcome
Behavior and symptoms
Time frame: 12 months
Behavior and Symptom Identification Scale (BASIS-32)
knowledge on treatment preference
Time frame: 1 month
patient activation (coping)
Time frame: 4 months
measured with Patient Activation Measure (PAM)
7 secondary outcomes
Client satisfaction
Time frame: Baseline, 4 and 12 months
Perceived participation
Time frame: Baseline, 4 and 12 months
Psychiatric Out-Patient Experiences
Time frame: Baseline, 4 and 12 months
Quality of Life
Time frame: Baseline, 4 and 12 months
motivation for treatment
Time frame: Baseline, 1 and 4 months
costs
Time frame: Baseline, 1, 4 and 12 months
Knowledge
Time frame: Baseline, 1, 4 and 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 5 Sep 2018.
- Results publication: PubMed 30157839Koksvik JM, Linaker OM, Grawe RW, Bjorngaard JH, Lara-Cabrera ML. The effects of a pretreatment educational group programme on mental health treatment outcomes: a randomized controlled trial. BMC Health Serv Res. 2018 Aug 29;18(1):665. doi: 10.1186/s12913-018-3466-2.
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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 Introduction seminar 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 2 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?
Behavior and symptoms (time frame: 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 NCT00967265, 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 5 Sep 2018.