Mental Health DisordersNCT01601587
Introduction Seminar About Patient Participation and Treatment Options Decisional Preferences
A study testing A psychoeducational group intervention. in people with Mental Health Disorders, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
Patient participation (PP) in Hospital is a goal defined by the Norwegian Health Authorities and it is a mandatory activity for District Psychiatric out-patient Centres (DPC) in Norway: patients are entitled to have influence on their treatment and should receive sufficient information directed at empowerment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Mental Health Disorders
- What is being tested?
- A psychoeducational group intervention.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteNorway
- Study dates
- May 2012to Jun 2015
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- older than 18 years
- referred for out-patient treatment
- guarantee of starting treatment between 2 and 4 months
Who cannot join
- guarantee of starting treatment in less than 2 months
- Patients who do not understand the consequences of taking part of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Introduction Seminar About Patient Participation, Treatment Options and Decisional Preferences for Psychiatric Outpatients on Waiting List
Patient participation (PP) in Hospital is a goal defined by the Norwegian Health Authorities and it is a mandatory activity for District Psychiatric out-patient Centres (DPC) in Norway: patients are entitled to have influence on their treatment and should receive sufficient information directed at empowerment. Nevertheless, studies from Norway have found that patients who seek help are dissatisfied with the information they receive and doubt their possibility for real influence on their treatment. One way to improve individual PP might be to give patients sufficient information and education before they start their treatment in the form of an educational group intervention, an introduction seminar (IS); this group intervention is less time and resource consuming than individual interventions.
Aims: The main purpose of this project is to develop and evaluate an IS for patients on a waiting list of DPC. The seminar will educate patients, so they can actively participate in their own treatment and, thereby, choosing treatment, reducing the risk of dropping out of treatment. Another aim is to enable patients to participate in their own treatment, to cope with their problems while they are waiting for treatment by providing them contact with primary health care and user organizations during their waiting time, and to increase adherence.
Methods: The project involves three components: an exploratory study of educational content of the seminar; RCT of that 4-hours program (to examine its effect on treatment preferences and choices, activation, satisfaction, mental health and cost-benefit) and then a post-seminar qualitative evaluation, which will be used to create a broad yet deep understanding of the practical side of the participants'experience and the seminar's effect.
Read the detailed description
Part I: An exploratory study of educational content of the seminar: a qualitative study (started october 2011)
Part II (RCT)
The intervention:
The introduction seminar will be held over one half day, 4 hours. Up to 15 patients can participate in each seminar. The content was developed based on study 1. The presentation about available treatment options and patient's rights are made by multi professional health personnel and user representatives. More specifically, this will be done under the following topics:
- What is mental health?
- Treatment options: orientation about individual and group based treatment modalities.
- Former patients experience with their own treatment, self-help and participation.
- How to influence and participate actively in the treatment and patient rights.
- What can I do while I wait for treatment and where can I otherwise do to avoid aggravation?.
At the end of the day, the patients will be divided into small groups mentored by health personnel where they can discuss the presentations and ask questions. In the breaks, literature and other kinds 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.
Sample size Selected Treatment: The number of patients is calculated based on a significance level of 5% and a power of 93%. The numbers needed in each group becomes 25 (calculated using IR), and the aim is to include a total of 52 patients in the RCT. It is controlled that it is feasible to recruit this number of patients.
PAM: Number of patients is calculated based on a significance level of 5% and a power of 87%. The standard deviation is estimated to be 13.8 and 9.7 (Pilot RCT data). The numbers needed in each group becomes 25 (calculated using SamplePower v2.0, SPSS Inc), and the aim is to include a total of 52 patients. It is controlled that it is feasible to recruit this number of patients.
Part III Qualitative and quantitative analysis:
To obtain information about the patients experience after the intervention, a post-seminar qualitative evaluation will be conducted:
15 randomly selected patients will additionally participate in the seminar, and they will be take part in Part III and in the quantitative part of the study.
- Conditions
- Mental Health Disorders
- Being tested
- A psychoeducational group intervention.
- Keywords
- Introductory Seminar, Waiting list, Community Mental Health Centre
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A psychoeducational group intervention.Other
The intervention is an introduction seminar. It will be held over FOUR hours. Up to 15 patients can participate in each seminar. The content of the was developed based on study 1. The presentation about available treatment options and patient's rights are made by multi professional health personnel and user representatives. More specifically, this will be done under the following topics:
- What is mental health?
- Treatment options: orientation about individual and group based treatment modalities.
- Former patients experience with their own treatment, self-help and participation.
- How to influence and participate actively in the treatment and patient rights.
- What can I do while I wait for treatment and where can I otherwise do to avoid aggravation?
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual | No intervention | Patients will receive treatment as usual |
| Introduction Seminar | Other | Psychoeducational group Receives: Other: A psychoeducational group intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Selected Treatment
one single question
Measured: 1 month
Health Care utilization
Health care registration (adherence, attendance, consultations, dropout's rates and cost)
Measured: 1 year
Health Care utilization
Health care registration (adherence, attendance, consultations, dropout's rates and cost)
Measured: 2 years
coping
Patient Activation Measure (PAM-13)
Measured: 4 months
Secondary outcomes (4)
Preferences for involvement in treatment decision making
Control Preferences Scale
Measured: Baseline, 1, 4 and 12 months
Treatment Satisfaction
Client Satisfaction Questionnaire-8 (CSQ-8)
Measured: Baseline, 1, 4, and 12 months
Quality of Life
WHO-Five Well-being Index (WHO-5)
Measured: Baseline, 1, 4 and 12 months
Motivation
One single question about motivation for treatment.
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 posted18 May 2012 (estimated)
- Study startMay 2012
- Primary completionJun 2015
- Study completionJun 2015
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 Health 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Olav Linaker, md phd, Principal investigator, National Taiwan Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01601587
- Sponsor's protocol ID
- 4.2009.77.2009/1980 ( part 2)
- Status last verified
- Aug 2018
- First submitted
- 10 May 2012
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lara-Cabrera ML, Salvesen O, Nesset MB, De las Cuevas C, Iversen VC, Grawe RW. The effect of a brief educational programme added to mental health treatment to improve patient activation: A randomized controlled trial in community mental health centres. Patient Educ Couns. 2016 May;99(5):760-8. doi: 10.1016/j.pec.2015.11.028. Epub 2015 Dec 2.
PubMed 26682971
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, Treatment Options and Decisional Preferences for Psychiatric Outpatients on Waiting List
- ClinicalTrials.gov ID
- NCT01601587
- Acronym / sponsor ID
- 4.2009.77.2009/1980 ( part 2)
- Conditions
- Mental Health Disorders
- Keywords
- Introductory Seminar, Waiting list, Community Mental Health Centre
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- May 2012 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 18 May 2012 (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 (PP) in Hospital is a goal defined by the Norwegian Health Authorities and it is a mandatory activity for District Psychiatric out-patient Centres (DPC) in Norway: patients are entitled to have influence on their treatment and should receive sufficient information directed at empowerment. Nevertheless, studies from Norway have found that patients who seek help are dissatisfied with the information they receive and doubt their possibility for real influence on their treatment. One way to improve individual PP might be to give patients sufficient information and education before they start their treatment in the form of an educational group intervention, an introduction seminar (IS); this group intervention is less time and resource consuming than individual interventions.
Aims: The main purpose of this project is to develop and evaluate an IS for patients on a waiting list of DPC. The seminar will educate patients, so they can actively participate in their own treatment and, thereby, choosing treatment, reducing the risk of dropping out of treatment. Another aim is to enable patients to participate in their own treatment, to cope with their problems while they are waiting for treatment by providing them contact with primary health care and user organizations during their waiting time, and to increase adherence.
Methods: The project involves three components: an exploratory study of educational content of the seminar; RCT of that 4-hours program (to examine its effect on treatment preferences and choices, activation, satisfaction, mental health and cost-benefit) and then a post-seminar qualitative evaluation, which will be used to create a broad yet deep understanding of the practical side of the participants'experience and the seminar's effect.
Detailed description
Part I: An exploratory study of educational content of the seminar: a qualitative study (started october 2011)
Part II (RCT)
The intervention:
The introduction seminar will be held over one half day, 4 hours. Up to 15 patients can participate in each seminar. The content was developed based on study 1. The presentation about available treatment options and patient's rights are made by multi professional health personnel and user representatives. More specifically, this will be done under the following topics:
- What is mental health?
- Treatment options: orientation about individual and group based treatment modalities.
- Former patients experience with their own treatment, self-help and participation.
- How to influence and participate actively in the treatment and patient rights.
- What can I do while I wait for treatment and where can I otherwise do to avoid aggravation?.
At the end of the day, the patients will be divided into small groups mentored by health personnel where they can discuss the presentations and ask questions. In the breaks, literature and other kinds 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.
Sample size Selected Treatment: The number of patients is calculated based on a significance level of 5% and a power of 93%. The numbers needed in each group becomes 25 (calculated using IR), and the aim is to include a total of 52 patients in the RCT. It is controlled that it is feasible to recruit this number of patients.
PAM: Number of patients is calculated based on a significance level of 5% and a power of 87%. The standard deviation is estimated to be 13.8 and 9.7 (Pilot RCT data). The numbers needed in each group becomes 25 (calculated using SamplePower v2.0, SPSS Inc), and the aim is to include a total of 52 patients. It is controlled that it is feasible to recruit this number of patients.
Part III Qualitative and quantitative analysis:
To obtain information about the patients experience after the intervention, a post-seminar qualitative evaluation will be conducted:
15 randomly selected patients will additionally participate in the seminar, and they will be take part in Part III and in the quantitative part of the study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual | No intervention | –Patients will receive treatment as usual |
| Introduction Seminar | Other | Other: A psychoeducational group intervention.Psychoeducational group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- older than 18 years
- referred for out-patient treatment
- guarantee of starting treatment between 2 and 4 months
Key exclusion criteria (2 listed)
- guarantee of starting treatment in less than 2 months
- Patients who do not understand the consequences of taking part of 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 |
|---|---|---|
| A psychoeducational group intervention.The intervention is an introduction seminar. It will be held over FOUR hours. Up to 15 patients can participate in each seminar. The content of the was developed based on study 1. The presentation about available treatment options and patient's rights are made by multi professional health personnel and user representatives. More specifically, this will be done under the following topics: 1. What is mental health? 2. Treatment options: orientation about individual and group based treatment modalities. 3. Former patients experience with their own treatment, self-help and participation. 4. How to influence and participate actively in the treatment and patient rights. 5. What can I do while I wait for treatment and where can I otherwise do to avoid aggravation? | Other | Introduction Seminar |
Primary outcome
Selected Treatment
Time frame: 1 month
one single question
Health Care utilization
Time frame: 1 year
Health care registration (adherence, attendance, consultations, dropout's rates and cost)
Health Care utilization
Time frame: 2 years
Health care registration (adherence, attendance, consultations, dropout's rates and cost)
coping
Time frame: 4 months
Patient Activation Measure (PAM-13)
4 secondary outcomes
Preferences for involvement in treatment decision making
Time frame: Baseline, 1, 4 and 12 months
Treatment Satisfaction
Time frame: Baseline, 1, 4, and 12 months
Quality of Life
Time frame: Baseline, 1, 4 and 12 months
Motivation
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 26682971Lara-Cabrera ML, Salvesen O, Nesset MB, De las Cuevas C, Iversen VC, Grawe RW. The effect of a brief educational programme added to mental health treatment to improve patient activation: A randomized controlled trial in community mental health centres. Patient Educ Couns. 2016 May;99(5):760-8. doi: 10.1016/j.pec.2015.11.028. Epub 2015 Dec 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.
Olav Linaker, md phd 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 A psychoeducational group intervention. in people with Mental Health 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 3 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?
Selected Treatment (time frame: 1 month). The study lists 4 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 NCT01601587, 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.