Mental DisorderNCT00184379
Effects of Psychoeducation of Relatives to Patients With Serious Mental Illness
A study testing Psychoeducation in people with Mental Disorder and Depressive Disorder, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The purpose of this study is to determine the effects of psychoeducation for relatives to patients with serious mental illness. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Mental Disorder, Depressive Disorder, Schizophrenia
- What is being tested?
- Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2005to Jun 2010
- 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
- Relatives to patients having a psychotic or bipolar disorder
- Good Norwegian language skills
- Consent to participate
- The patients' consent for their relatives to participate
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Østmarka Psychiatric Department, St. Olavs Hospital, University Hospital of Trondheim
Trondheim
About this study
The purpose of this study is to determine the effects of psychoeducation for relatives to patients with serious mental illness.
Read the detailed description
The main aim of the study is to compare the effects of group psychoeducation for relatives to patients with serious mental illness with a waiting list control group. The main hypothesis is whether psychoeducation in groups has effects on the stress experience and coping style in the relatives. The relatives will receive group education in 6 weekly sessions. We will measure stress experience, coping style and the relatives' health condition before the sessions, after the sessions and at one year follow-up.
- Conditions
- Mental Disorder, Depressive Disorder, Schizophrenia
- Being tested
- Psychoeducation
- Keywords
- Family, Coping Skills, Psychoeducation, Stress, Psychological, Health Education
- Medical subject headings
- Mental Disorders, Depressive Disorder, Schizophrenia, Stress, Psychological, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychoeducationBehavioural
Structured disorder-related educational program for relatives
| Study group | Role | What they receive |
|---|---|---|
| 1 S+E | Experimental | Relatives of patients with schizophrenia, who receive education Receives: Behavioral: Psychoeducation |
| 2 S-E | No intervention | Relatives of patients with schizophrenia, who do not receive education |
| 3 B+E | Experimental | Relatives of patients with bipolar disorder, who receive education Receives: Behavioral: Psychoeducation |
| 4 B-E | No intervention | Relatives of patients with bipolar disorder, who do not receive education |
What is being measured
The primary outcome is the main question the study is designed to answer.
ECI (Experience of Caregiving Inventory) (Smuckler et al,1994)
Measured: 0-6 months
COOP/WONCA (Bowling, 1995)
Measured: 0-6 months
Selection of questions from COPE (Carver et al. 1989)
Measured: 0-6 months
Evaluation-questions
Measured: 0-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startApr 2005
- Primary completionJun 2010
- Study completionJun 2010
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 DisorderStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 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 M Linaker, MD Prof, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00184379
- Sponsor's protocol ID
- 4.2005.389
- Status last verified
- Aug 2017
- First submitted
- 13 Sep 2005
- Last updated
- 28 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Moller T, Gudde CB, Folden GE, Linaker OM. The experience of caring in relatives to patients with serious mental illness: gender differences, health and functioning. Scand J Caring Sci. 2009 Mar;23(1):153-60. doi: 10.1111/j.1471-6712.2008.00605.x. Epub 2009 Jan 21.
PubMed 19192243
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Psychoeducation of Relatives to Patients With Serious Mental Illness
- ClinicalTrials.gov ID
- NCT00184379
- Acronym / sponsor ID
- 4.2005.389
- Conditions
- Mental Disorder, Depressive Disorder, Schizophrenia
- Keywords
- Family, Coping Skills, Psychoeducation, Stress, Psychological, Health Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- Apr 2005
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 16 Sep 2005 (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 determine the effects of psychoeducation for relatives to patients with serious mental illness.
Detailed description
The main aim of the study is to compare the effects of group psychoeducation for relatives to patients with serious mental illness with a waiting list control group. The main hypothesis is whether psychoeducation in groups has effects on the stress experience and coping style in the relatives. The relatives will receive group education in 6 weekly sessions. We will measure stress experience, coping style and the relatives' health condition before the sessions, after the sessions and at one year follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 S+E | Experimental | Behavioral: PsychoeducationRelatives of patients with schizophrenia, who receive education |
| 2 S-E | No intervention | –Relatives of patients with schizophrenia, who do not receive education |
| 3 B+E | Experimental | Behavioral: PsychoeducationRelatives of patients with bipolar disorder, who receive education |
| 4 B-E | No intervention | –Relatives of patients with bipolar disorder, who do not receive education |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Relatives to patients having a psychotic or bipolar disorder
- Good Norwegian language skills
- Consent to participate
- The patients' consent for their relatives to participate
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| PsychoeducationStructured disorder-related educational program for relatives | Behavioural | 1 S+E, 3 B+E |
Primary outcome
ECI (Experience of Caregiving Inventory) (Smuckler et al,1994)
Time frame: 0-6 months
COOP/WONCA (Bowling, 1995)
Time frame: 0-6 months
Selection of questions from COPE (Carver et al. 1989)
Time frame: 0-6 months
Evaluation-questions
Time frame: 0-6 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 28 Aug 2017.
- Results publication: PubMed 19192243Moller T, Gudde CB, Folden GE, Linaker OM. The experience of caring in relatives to patients with serious mental illness: gender differences, health and functioning. Scand J Caring Sci. 2009 Mar;23(1):153-60. doi: 10.1111/j.1471-6712.2008.00605.x. Epub 2009 Jan 21.
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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 Prof 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 Psychoeducation in people with Mental Disorder and Depressive Disorder, 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 4 inclusion and 0 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 28 Aug 2017. 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?
ECI (Experience of Caregiving Inventory) (Smuckler et al,1994) (time frame: 0-6 months). 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 NCT00184379, 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 28 Aug 2017.