Families of Mentally IllNCT00258167
Family Involvement in The Treatment Of a Mentally Ill Relative
A study testing filling the "Experience of Caregiving Inventory" in people with Families of Mentally Ill, run by Lev-Hasharon Mental Healtlh Center at 1 site in Israel.
Trial summary
Research demonstrates that the families of the seriously mentally ill are burdened by this caregiving role and by their responsibilities Research also demonstrates that family interventions are effective and that they have a potential to reduce family burden, as well as to improve the condition of the mentally ill… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Families of Mentally Ill
- What is being tested?
- filling the "Experience of Caregiving Inventory"
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2005to Nov 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- siblings of persons with mental illness
Who cannot join
- persons junior then 18 years old
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Lev-HasharonMHC
Netanya, 42100
Igor Oyffe, MD, 972-9-8981248, ioyffe@lev-hasharon.co.il
Shuvit Melamed, MSW, +972-9-8981278, shuvitm@lev-hasharon.co.il
About this study
- Research demonstrates that the families of the seriously mentally ill are burdened by this caregiving role and by their responsibilities
- Research also demonstrates that family interventions are effective and that they have a potential to reduce family burden, as well as to improve the condition of the mentally ill patients.
- We assume that the sibling group intervention would be effective in reducing the family burden of the siblings, and that this reduction would be reflected in their replies to the "Experience of Caregiving Inventory".
Read the detailed description
- The group for siblings is an intervention which is carried out in the outpatient clinic of Lev HaSharon Mental Health Center in cycles which last eight weeks;
- Every group cycle will include between 10-14 participants, all siblings of persons with mental illness. The patients themselves (ill siblings) are either hospitalized in Lev HaSharon Mental Health Center, or are outpatients in the Lev HaSharon Mental Health Outpatient Unit, or in the community at large.
- The group is an ongoing group: short term intensive group intervention in a dynamic orientation. Veteran participants of each cycle are welcome to re-join at following cycles, and at the same time new participants can join at the beginning of each cycle.
- Participants will be asked to fill the "Experience of Caregiving Inventory" twice: first time before the first meeting of a particular cycle of sibling group and second time: after the last (eighth) meeting of this group cycle.
- Conditions
- Families of Mentally Ill
- Being tested
- filling the "Experience of Caregiving Inventory"
- Keywords
- Family members, Illness burden, Mental Disorders, Family intervention
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filling the "Experience of Caregiving Inventory"Behavioural
8 weeks of group therapy for family members
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on the "Experience of Caregiving Inventory" following 8 weeks of participation in the group.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2005 (estimated)
- Study startNov 2005
- Primary completionNov 2008 (estimated)
- Study completionNov 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Families of Mentally IllStudies 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lev-Hasharon Mental Healtlh Center
- Sponsor type
- Other government
- Investigators
- Igor Oyffe, MD, Principal investigator, Lev-Hasharon Mental Healtlh Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00258167
- Sponsor's protocol ID
- LH12/2005.CTIL
- Status last verified
- Jun 2008
- First submitted
- 23 Nov 2005
- Last updated
- 11 Jun 2008
- Results posted
- No
Publications
Melamed, S. Permission: A conceptual tool for treating mentally ill patients and their families. Journal of Family Psychotherapy. 12 (2). Pp. 29-42, 2001.
Dixon L, McFarlane WR, Lefley H, Lucksted A, Cohen M, Falloon I, Mueser K, Miklowitz D, Solomon P, Sondheimer D. Evidence-based practices for services to families of people with psychiatric disabilities. Psychiatr Serv. 2001 Jul;52(7):903-10. doi: 10.1176/appi.ps.52.7.903.
PubMed 11433107
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Involvement in The Treatment Of a Mentally Ill Relative
- ClinicalTrials.gov ID
- NCT00258167
- Acronym / sponsor ID
- LH12/2005.CTIL
- Conditions
- Families of Mentally Ill
- Keywords
- Family members, Illness burden, Mental Disorders, Family intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Lev-Hasharon Mental Healtlh CenterOther government
- Study start
- Nov 2005
- Primary completion
- Nov 2008 (estimated)
- Study completion
- Nov 2008 (estimated)
- First posted
- 24 Nov 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.
- Research demonstrates that the families of the seriously mentally ill are burdened by this caregiving role and by their responsibilities
- Research also demonstrates that family interventions are effective and that they have a potential to reduce family burden, as well as to improve the condition of the mentally ill patients.
- We assume that the sibling group intervention would be effective in reducing the family burden of the siblings, and that this reduction would be reflected in their replies to the "Experience of Caregiving Inventory".
Detailed description
- The group for siblings is an intervention which is carried out in the outpatient clinic of Lev HaSharon Mental Health Center in cycles which last eight weeks;
- Every group cycle will include between 10-14 participants, all siblings of persons with mental illness. The patients themselves (ill siblings) are either hospitalized in Lev HaSharon Mental Health Center, or are outpatients in the Lev HaSharon Mental Health Outpatient Unit, or in the community at large.
- The group is an ongoing group: short term intensive group intervention in a dynamic orientation. Veteran participants of each cycle are welcome to re-join at following cycles, and at the same time new participants can join at the beginning of each cycle.
- Participants will be asked to fill the "Experience of Caregiving Inventory" twice: first time before the first meeting of a particular cycle of sibling group and second time: after the last (eighth) meeting of this group cycle.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- siblings of persons with mental illness
Key exclusion criteria (1 listed)
- persons junior then 18 years old
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 |
|---|---|---|
| filling the "Experience of Caregiving Inventory"8 weeks of group therapy for family members | Behavioural | – |
Primary outcome
Score on the "Experience of Caregiving Inventory" following 8 weeks of participation in the group.
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2008.
- BackgroundMelamed, S. Permission: A conceptual tool for treating mentally ill patients and their families. Journal of Family Psychotherapy. 12 (2). Pp. 29-42, 2001.
- Background: PubMed 11433107Dixon L, McFarlane WR, Lefley H, Lucksted A, Cohen M, Falloon I, Mueser K, Miklowitz D, Solomon P, Sondheimer D. Evidence-based practices for services to families of people with psychiatric disabilities. Psychiatr Serv. 2001 Jul;52(7):903-10. doi: 10.1176/appi.ps.52.7.903.
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 principal investigator
Lev-Hasharon Mental Healtlh 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 filling the "Experience of Caregiving Inventory" in people with Families of Mentally Ill, 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 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: status not confirmed, as of the sponsor's last update on 11 Jun 2008. 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 Igor Oyffe, MD (972-8981248, ioyffe@lev-hasharon.co.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score on the "Experience of Caregiving Inventory" following 8 weeks of participation in the group. (time frame: 8 weeks). 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 NCT00258167, which also lists 2 linked publications.
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 11 Jun 2008.