Bipolar Affective DisorderBADNCT00474357
Myths About Bipolar Affective Disorder: The Role of Structured Group Psychoeducation Therapy
A study testing Brief Structured Psychoeducation Group Therapy in people with Bipolar Affective Disorder, run by Lev-Hasharon Mental Healtlh Center at 1 site in Israel.
Trial summary
This study will examine: 1) The impact of psycho education group therapy sessions relating to beliefs/myths associated with bipolar affective disorder (BAD) on the emotional wellbeing, clinical course and cognition of individuals diagnosed with BAD 2) Will examine the existence of those same beliefs among the various… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Affective Disorder
- What is being tested?
- Brief Structured Psychoeducation Group Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteIsrael
- Study dates
- May 2007to Oct 2008
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- DSM-IV diagnosis of BAD
- State of remission
Who cannot join
- HAM-D score < 10
- YMRS score < 12
- Has a guardian for either self or property
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Lev Hasharon Mental Health Center
Netanya, 42100
Deby Peres, MD, +972-9-8981242 ext. 242, debyp@lev-hasharon.co.il
Igor Oyffe, MD, +972-9-8981248 ext. 248, igoro@lev-hasharon.co.il
About this study
This study will examine:
- The impact of psycho education group therapy sessions relating to beliefs/myths associated with bipolar affective disorder (BAD) on the emotional wellbeing, clinical course and cognition of individuals diagnosed with BAD 2) Will examine the existence of those same beliefs among the various caregivers - psychiatrists, general practitioners, social workers, and psychiatric nurses.
The investigators hypothesize that psychoeducation group therapy will be effective in refuting the myths and will lead to better treatment adherence, longer remissions, fewer hospitalizations, improved self esteem, increased optimism, and better control over the disease process. The investigators also believe that they will identify some beliefs/myths or preconceived notions that are common to both caregivers and individuals with BAD.
Read the detailed description
Methods:
Effect psychoeducation:
Study population - 30 patients diagnosed with BAD treated in the outpatient clinic, in a state of remission will be evaluated with the Hamilton Rating Scale for Depression, Young Mania Rating Scale, and will then participate in 7 weekly sessions of brief structured psycho education therapy Control group - 30 patients diagnosed with BAD treated in the outpatient clinic, in a state of remission will be evaluated with the Hamilton Rating Scale for Depression, Young Mania Rating Scale. In addition both groups will complete the Snyder Hope Scale, Accepting the Mental Illness Label Scale and a questionnaire regarding Myths in BAD prior to the study, and when the study group finishes their group therapy sessions. (Controls will not participate in the psychoeducation group therapy).
Caregivers beliefs:
50 caregivers from various professions will complete the questionnaire regarding the myths, once only.
- Conditions
- Bipolar Affective Disorder
- Being tested
- Brief Structured Psychoeducation Group Therapy
- Keywords
- Bipolar affective disorder, myths, preconceived notions, stigma, hope
- Medical subject headings
- Bipolar Disorder, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Structured Psychoeducation Group TherapyBehavioural
weekly brief structured psychoeducation group therapy for seven weeks for bipolar patients
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Bipolar patients participating in psychoeducation intervention Receives: Behavioral: Brief Structured Psychoeducation Group Therapy |
| 2 | No intervention | bipolar patients who do not participate in psychoeducation group |
| 3 | No intervention | Therapists will complete questionnaires regarding myths about bipolar patients, no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accepting Mental Illness Scale
Measured: 7 weeks
Secondary outcomes (2)
Hope Scale
Measured: 7 weeks
Myths about BAD questionnaire
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2007 (estimated)
- Study startMay 2007
- Primary completionOct 2008 (estimated)
- Study completionOct 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar Affective DisorderStudies of the same condition, open and under way.
- 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
- Supportive care
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lev-Hasharon Mental Healtlh Center
- Sponsor type
- Other government
- Investigators
- Igor Oyffe, MD, Study director, Lev HaSharon Mental Health CenterDeby Peres, MD, Principal investigator, Lev HaSharon Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00474357
- Sponsor's protocol ID
- LH55/2007.CTIL
- Acronym
- BAD
- Status last verified
- May 2008
- First submitted
- 15 May 2007
- Last updated
- 17 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myths About Bipolar Affective Disorder: The Role of Structured Group Psychoeducation Therapy
- ClinicalTrials.gov ID
- NCT00474357
- Acronym / sponsor ID
- BAD / LH55/2007.CTIL
- Conditions
- Bipolar Affective Disorder
- Keywords
- Bipolar affective disorder, myths, preconceived notions, stigma, hope
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Lev-Hasharon Mental Healtlh CenterOther government
- Study start
- May 2007
- Primary completion
- Oct 2008 (estimated)
- Study completion
- Oct 2008 (estimated)
- First posted
- 16 May 2007 (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.
This study will examine:
- The impact of psycho education group therapy sessions relating to beliefs/myths associated with bipolar affective disorder (BAD) on the emotional wellbeing, clinical course and cognition of individuals diagnosed with BAD 2) Will examine the existence of those same beliefs among the various caregivers - psychiatrists, general practitioners, social workers, and psychiatric nurses.
The investigators hypothesize that psychoeducation group therapy will be effective in refuting the myths and will lead to better treatment adherence, longer remissions, fewer hospitalizations, improved self esteem, increased optimism, and better control over the disease process. The investigators also believe that they will identify some beliefs/myths or preconceived notions that are common to both caregivers and individuals with BAD.
Detailed description
Methods:
Effect psychoeducation:
Study population - 30 patients diagnosed with BAD treated in the outpatient clinic, in a state of remission will be evaluated with the Hamilton Rating Scale for Depression, Young Mania Rating Scale, and will then participate in 7 weekly sessions of brief structured psycho education therapy Control group - 30 patients diagnosed with BAD treated in the outpatient clinic, in a state of remission will be evaluated with the Hamilton Rating Scale for Depression, Young Mania Rating Scale. In addition both groups will complete the Snyder Hope Scale, Accepting the Mental Illness Label Scale and a questionnaire regarding Myths in BAD prior to the study, and when the study group finishes their group therapy sessions. (Controls will not participate in the psychoeducation group therapy).
Caregivers beliefs:
50 caregivers from various professions will complete the questionnaire regarding the myths, once only.
Study design
- Primary purpose
- Supportive care
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Brief Structured Psychoeducation Group TherapyBipolar patients participating in psychoeducation intervention |
| 2 | No intervention | –bipolar patients who do not participate in psychoeducation group |
| 3 | No intervention | –Therapists will complete questionnaires regarding myths about bipolar patients, no intervention |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- DSM-IV diagnosis of BAD
- State of remission
Key exclusion criteria (3 listed)
- HAM-D score < 10
- YMRS score < 12
- Has a guardian for either self or property
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 |
|---|---|---|
| Brief Structured Psychoeducation Group Therapyweekly brief structured psychoeducation group therapy for seven weeks for bipolar patients | Behavioural | 1 |
Primary outcome
Accepting Mental Illness Scale
Time frame: 7 weeks
2 secondary outcomes
Hope Scale
Time frame: 7 weeks
Myths about BAD questionnaire
Time frame: 7 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2010.
- Lev-Hasharon Mental Health CenterLink provided by the sponsor.
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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.
Igor Oyffe, MD study director
Lev HaSharon Mental Health Center
Deby Peres, MD principal investigator
Lev HaSharon Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Structured Psychoeducation Group Therapy in people with Bipolar Affective Disorder, run by Lev-Hasharon Mental Healtlh Center at 1 site in Israel.
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 2 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: status not confirmed, as of the sponsor's last update on 17 Dec 2010. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Deby Peres, MD (+972-9-8981242 ext. 242, debyp@lev-hasharon.co.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accepting Mental Illness Scale (time frame: 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Dec 2010.