Brain InjuriesNCT00166348
Does Cognitive Rehabilitation Demonstrate Benefits in the Group Setting With People Whom Have Experienced Brain Injury?
A study testing Cognitive Group Therapy in people with Brain Injuries, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to determine whether there is benefit from providing cognitive rehabilitation in the group setting. Several standardized tools will be used to measure progress when a participant enters the group, leaves the group and at a one year follow-up. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Injuries
- What is being tested?
- Cognitive Group Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2003to Mar 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
- All participants involved in the Cognitive Rehabilitation Outpatient Group within the study time frame are eligible to be in the study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Group Based Cognitive Rehabilitation Following Acquired Brain Injury
The purpose of this study is to determine whether there is benefit from providing cognitive rehabilitation in the group setting. Several standardized tools will be used to measure progress when a participant enters the group, leaves the group and at a one year follow-up.
Read the detailed description
This research study will look at the outcome benefits of providing cognitive rehabilitation, utilizing the group process. Criteria for selecting the appropriate participants, group format and structure, as well as use of standardized assessments. The assessments used: Three Step Calendar Approach, (Sohlberg and Mateer) Satisfaction With Life scale (SWLS), Community Integration Questionnaire (CIQ), Independent Living Scale, and the Vocational Independence Scale. The group setting provides an atmosphere to work on building communication skills through peer feedback and to develop psychological coping strategies. Techniques such as the problem solving format and a calendar system. Analysis and outcomes of 17 past group participants were analyzed supporting cognitive rehabilitation in the group setting.
Of the 20 participants, 3 chose not to be included.
- Conditions
- Brain Injuries
- Being tested
- Cognitive Group Therapy
- Keywords
- Cognitive Rehabilitation
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Group TherapyBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
provide evidence which supports cognitive therapy in a group setting
less labor intensive
cost effectiveness
peer feedback is effective
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startMar 2003
- Primary completionFeb 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Nicloe Holzworth, OTR/L, Bergequist, Thomas, Ph.D., Brown, Allen, M.D., Sue Lepore, OTR/L, Walter Stobaugh. LICSW
- Investigators
- Merri L Vitse, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00166348
- Sponsor's protocol ID
- 1069-03
- Status last verified
- Jan 2010
- First submitted
- 12 Sep 2005
- Last updated
- 20 Jan 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Group Based Cognitive Rehabilitation Following Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT00166348
- Acronym / sponsor ID
- 1069-03
- Conditions
- Brain Injuries
- Keywords
- Cognitive Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Nicloe Holzworth, OTR/L, Bergequist, Thomas, Ph.D., Brown, Allen, M.D., Sue Lepore, OTR/L, Walter Stobaugh. LICSW
- Study start
- Mar 2003
- Primary completion
- Feb 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 14 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 whether there is benefit from providing cognitive rehabilitation in the group setting. Several standardized tools will be used to measure progress when a participant enters the group, leaves the group and at a one year follow-up.
Detailed description
This research study will look at the outcome benefits of providing cognitive rehabilitation, utilizing the group process. Criteria for selecting the appropriate participants, group format and structure, as well as use of standardized assessments. The assessments used: Three Step Calendar Approach, (Sohlberg and Mateer) Satisfaction With Life scale (SWLS), Community Integration Questionnaire (CIQ), Independent Living Scale, and the Vocational Independence Scale. The group setting provides an atmosphere to work on building communication skills through peer feedback and to develop psychological coping strategies. Techniques such as the problem solving format and a calendar system. Analysis and outcomes of 17 past group participants were analyzed supporting cognitive rehabilitation in the group setting.
Of the 20 participants, 3 chose not to be included.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All participants involved in the Cognitive Rehabilitation Outpatient Group within the study time frame are eligible to be in the study.
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 |
|---|---|---|
| Cognitive Group Therapy | Behavioural | – |
Primary outcome
provide evidence which supports cognitive therapy in a group setting
less labor intensive
cost effectiveness
peer feedback is effective
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 20 Jan 2010.
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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.
Merri L Vitse principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Group Therapy in people with Brain Injuries, run by Mayo Clinic 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 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 20 Jan 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 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.
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?
provide evidence which supports cognitive therapy in a group setting. 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 20 Jan 2010.