Child Abuse SurvivorsMICASNCT00867802
Mindfulness Intervention For Child Abuse Survivors (MICAS)
A study testing Mindfulness-Based Stress Reduction program in people with Child Abuse Survivors, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
The purpose of this study is to assess the effect of meditation training called Mindfulness-Based Stress Reduction on reducing the symptoms of psychological distress among adult survivors of child abuse. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Child Abuse Survivors
- What is being tested?
- Mindfulness-Based Stress Reduction program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Mar 2009
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A history of child abuse, as attested by the potential participant
- Currently in therapy with a licensed psychotherapist (psychiatrist, psychologist, social worker).
- Plans to remain in therapy with a licensed psychotherapist (psychiatrist, psychologist, social worker) for the duration of the study.
- Recommendation made by the potential participant's licensed psychotherapist (psychiatrist, psychologist, social worker) the Mindfulness-Based Stress Reduction program would be an appropriate adjunct therapy for his or her client.
- Score of 0.50 or higher on the General Severity Index of the Brief Symptom Inventory, indicating psychological distress above the normal population.
- Aged 21 or above.
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- Ability to read and write English.
- Able to attend 10 courses and assessment visits over a 6-week period.
- Willing to practice skills for 20-30 minutes per day 6 days a week, during the course.
Who cannot join
- Major psychiatric illness (bipolar disorder, schizophrenia, dissociative identity disorder, or others).
- Active alcoholism or drug dependency.
- Any psychological or physical illness the investigator feels would prohibit full participation in the course.
- Currently enrolled in another clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mindfulness Intervention For Child Abuse Survivors
The purpose of this study is to assess the effect of meditation training called Mindfulness-Based Stress Reduction on reducing the symptoms of psychological distress among adult survivors of child abuse.
Read the detailed description
The specific aims of the project are:
- To determine whether Mindfulness- Based Stress Reduction program is associated with a reduction in symptoms of depression, anxiety, and psychological distress.
- To assess indications of efficacy, assess feasibility of enrollment and compliance among this patient population
- Provide pilot data that can be used to apply for larger grants to more fully develop this approach
- Conditions
- Child Abuse Survivors
- Being tested
- Mindfulness-Based Stress Reduction program
- Keywords
- MICAS, MBSR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Stress Reduction programBehavioural
Mindfulness- Based Stress Reduction comprising of 8 classes and a one-day retreat, taught over a period of 6 weeks. Intervention also includes practice at home for 20-30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness- Based Stress Reduction: Active Comparator | Experimental | Mindfulness-Based Stress Reduction program Receives: Behavioral: Mindfulness-Based Stress Reduction program |
What is being measured
The primary outcome is the main question the study is designed to answer.
To administer the Brief Symptom Inventory (BSI) questionnaire at each visit in order to assess psychological distress.
Measured: 6 weeks
Secondary outcomes (1)
Trauma Symptom Inventory to all participants at each visit. Administer the Beck Depression Inventory (BDI) to all participants. Functional Assessment of Chronic Illness Therapy spiritual Well-Being (FACIT-SP)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2009 (estimated)
- Study startMay 2007
- Primary completionSep 2008
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child Abuse SurvivorsStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Berman, University of Maryland, Baltimore
- Investigators
- Elizabeth Pradhan, PhD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00867802
- Sponsor's protocol ID
- HP-00041191
- Acronym
- MICAS
- Status last verified
- Feb 2022
- First submitted
- 8 Dec 2008
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Intervention For Child Abuse Survivors
- ClinicalTrials.gov ID
- NCT00867802
- Acronym / sponsor ID
- MICAS / HP-00041191
- Conditions
- Child Abuse Survivors
- Keywords
- MICAS, MBSR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 24 Mar 2009 (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 assess the effect of meditation training called Mindfulness-Based Stress Reduction on reducing the symptoms of psychological distress among adult survivors of child abuse.
Detailed description
The specific aims of the project are:
- To determine whether Mindfulness- Based Stress Reduction program is associated with a reduction in symptoms of depression, anxiety, and psychological distress.
- To assess indications of efficacy, assess feasibility of enrollment and compliance among this patient population
- Provide pilot data that can be used to apply for larger grants to more fully develop this approach
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindfulness- Based Stress Reduction: Active Comparator | Experimental | Behavioral: Mindfulness-Based Stress Reduction programMindfulness-Based Stress Reduction program |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- A history of child abuse, as attested by the potential participant
- Currently in therapy with a licensed psychotherapist (psychiatrist, psychologist, social worker).
- Plans to remain in therapy with a licensed psychotherapist (psychiatrist, psychologist, social worker) for the duration of the study.
- Recommendation made by the potential participant's licensed psychotherapist (psychiatrist, psychologist, social worker) the Mindfulness-Based Stress Reduction program would be an appropriate adjunct therapy for his or her client.
- Score of 0.50 or higher on the General Severity Index of the Brief Symptom Inventory, indicating psychological distress above the normal population.
Key exclusion criteria (4 listed)
- Major psychiatric illness (bipolar disorder, schizophrenia, dissociative identity disorder, or others).
- Active alcoholism or drug dependency.
- Any psychological or physical illness the investigator feels would prohibit full participation in the course.
- Currently enrolled in another clinical trial.
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 |
|---|---|---|
| Mindfulness-Based Stress Reduction programMindfulness- Based Stress Reduction comprising of 8 classes and a one-day retreat, taught over a period of 6 weeks. Intervention also includes practice at home for 20-30 minutes. | Behavioural | Mindfulness- Based Stress Reduction: Active Comparator |
Primary outcome
To administer the Brief Symptom Inventory (BSI) questionnaire at each visit in order to assess psychological distress.
Time frame: 6 weeks
1 secondary outcome
Trauma Symptom Inventory to all participants at each visit. Administer the Beck Depression Inventory (BDI) to all participants. Functional Assessment of Chronic Illness Therapy spiritual Well-Being (FACIT-SP)
Time frame: 24 weeks
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 14 Mar 2022.
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.
Elizabeth Pradhan, PhD principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Stress Reduction program in people with Child Abuse Survivors, run by University of Maryland, Baltimore 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 9 inclusion and 4 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 14 Mar 2022. 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?
To administer the Brief Symptom Inventory (BSI) questionnaire at each visit in order to assess psychological distress. (time frame: 6 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 14 Mar 2022.