Bipolar DisorderPhase 1NCT00296283
Family Workshops for Bipolar Disorder
A Phase 1 study testing integrative behavior couples therapy in people with Bipolar Disorder, run by University of Miami at 1 site in United States.
Trial summary
This pilot study is looking at the effects of a brief psychoeducational workshop. These one day workshops are designed to increase family members knowledge about bipolar disorder and to help with processing emotions that go along with having a relative with bipolar disorder. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- integrative behavior couples therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to not given
- Phase
- Phase 1
- 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 64 years
- All sexes
- Adult
Who may be able to join
- self-identified adult relatives of people diagnosed with bipolar disorder between ages 18 and 64; up to two persons per family can participate in the multifamily group
Who cannot join
- relative with bipolar disorder will not be involved in the workshop
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Acceptance Based Psychoeducation Intervention to Reduce Expressed Emotion in Family Members of Bipolar Patients
This pilot study is looking at the effects of a brief psychoeducational workshop. These one day workshops are designed to increase family members knowledge about bipolar disorder and to help with processing emotions that go along with having a relative with bipolar disorder.
- Conditions
- Bipolar Disorder
- Being tested
- integrative behavior couples therapy
- Keywords
- Relatives, Bipolar Disorder, Psychoeducation
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
integrative behavior couples therapyBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge
Anger
Attributions
Expressed Emotion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2006 (estimated)
- Study startAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Investigators
- Sheri Johnson, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00296283
- Sponsor's protocol ID
- 20051107
- Status last verified
- May 2007
- First submitted
- 23 Feb 2006
- Last updated
- 23 May 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Acceptance Based Psychoeducation Intervention to Reduce Expressed Emotion in Family Members of Bipolar Patients
- ClinicalTrials.gov ID
- NCT00296283
- Acronym / sponsor ID
- 20051107
- Conditions
- Bipolar Disorder
- Keywords
- Relatives, Bipolar Disorder, Psychoeducation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Aug 2005
- First posted
- 24 Feb 2006 (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 pilot study is looking at the effects of a brief psychoeducational workshop. These one day workshops are designed to increase family members knowledge about bipolar disorder and to help with processing emotions that go along with having a relative with bipolar disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Age groups
- Adult
Key inclusion criteria (1 listed)
- self-identified adult relatives of people diagnosed with bipolar disorder between ages 18 and 64; up to two persons per family can participate in the multifamily group
Key exclusion criteria (1 listed)
- relative with bipolar disorder will not be involved in the workshop
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 |
|---|---|---|
| integrative behavior couples therapy | Behavioural | – |
Primary outcome
Knowledge
Anger
Attributions
Expressed Emotion
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 23 May 2007.
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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.
Sheri Johnson, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing integrative behavior couples therapy in people with Bipolar Disorder, run by University of Miami at 1 site in United States.
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 23 May 2007. 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Knowledge. 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?
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 23 May 2007.