Impulsive BehaviorPhase 1/2REVAMPNCT01378923
Evaluation of Re-Entry Values and Mindfulness Program (REVAMP) With Jail Inmates
A Phase 1/2 study testing REVAMP and TAU in people with Impulsive Behavior and Substance Abuse, run by George Mason University at 1 site in United States.
Trial summary
This is a pilot study to examine the acceptability and effectiveness of the Re-Entry Values and Mindfulness Program (REVAMP), a group intervention for jail inmates. It is hypothesized that REVAMP will reduce post-release recidivism, substance abuse, and HIV risk behavior. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Impulsive Behavior, Substance Abuse, HIV Risk Behavior
- What is being tested?
- REVAMP and TAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Jun 2013
- Phase
- Phase 1/2
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be 18 years or older
- Must be male
- Must be currently incarcerated jail inmate
- Must be sentenced
- Sentence must be short enough to serve out sentence at the Adult Detention Center
- Release date must follow projected final session of treatment
- Must speak, read, and write in English with sufficient proficiency to use workbook and participate in group sessions
- Must be assigned to the jail's "general population"
Who cannot join
- Actively psychotic
- Assigned "keep separate" from other group members
Trial locations and contacts
1 site in 1 country.
United States1 site
Fairfax County Adult Detention Center
Fairfax, Virginia, 22030
About this study
Official title: Pilot Evaluation of the Re-Entry Values and Mindfulness Program (REVAMP) With Jail Inmates
This is a pilot study to examine the acceptability and effectiveness of the Re-Entry Values and Mindfulness Program (REVAMP), a group intervention for jail inmates. It is hypothesized that REVAMP will reduce post-release recidivism, substance abuse, and HIV risk behavior.
- Conditions
- Impulsive Behavior, Substance Abuse, HIV Risk Behavior, Anxiety, Depression, Criminogenic Thinking
- Being tested
- REVAMP, TAU
- Keywords
- Mindfulness, Values, Jail Inmates, Impulsivity, Substance Abuse, HIV risk behavior, Anxiety, Depression, Criminogenic Thinking
- Medical subject headings
- Impulsive Behavior, Substance-Related Disorders, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REVAMPBehavioural
The Re-entry values and mindfulness program (REVAMP) is an 8 session group intervention designed for jail inmates nearing release into the community
TAUBehavioural
have access to standard jail programs and services
| Study group | Role | What they receive |
|---|---|---|
| Values-based mindfulness group | Experimental | The Re-entry values and mindfulness program (REVAMP) is an 8 session group intervention designed for jail inmates nearing release into the community Receives: Behavioral: REVAMP |
| Treatment as usual | Other | has access to standard jail interventions and programs Receives: Behavioral: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recidivism - Self Report of undetected crimes
Measured: 3 months post-release
Recidivism - Self Report of Arrests
Measured: 3 months post-release
Recidivism - Official Records of arrests
Measured: 3 months post-release
Substance Dependence symptoms - Texas Christian University (TCU) measure
Measured: 3 months post-release
HIV Risk Behavior - Sex and Intravenous Drug Use (IDU) - TCU
Measured: 3 months post-release
Acceptability - number of participants who report finding the treatment helpful and number who would recommend the treatment to a friend
Measured: 1 week post-treatment
Secondary outcomes (5)
Mindfulness - Self report using Mindfulness Inventory: Nine Dimensions (MI:ND)
Measured: 1 week post-treatment and 3 months post-release
Self Control - Self report using Brief Self control Scale (BSC)
Measured: post-treatment and 3 months post-release
Self-Compassion - Self report using Neff's scale
Measured: 1 week post-treatment and 3 months post-release
Distress-Driven Impulsivity - Behavioral measure using Balloon Analog Reaction Test (BART) preceded by mirror tracing task
Measured: 1 week post-treatment
Psychological Symptoms - Self report using Personality Assessment Inventory
Measured: 1 week post-treatment and 3 months post-release
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2011 (estimated)
- Study startApr 2011
- Primary completionJun 2013 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impulsive BehaviorStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- George Mason University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, June Tangney, George Mason University
- Investigators
- June P Tangney, PhD, Principal investigator, George Mason University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01378923
- Sponsor's protocol ID
- CCT-01
- Acronym
- REVAMP
- Status last verified
- May 2013
- First submitted
- 17 Jun 2011
- Last updated
- 7 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Evaluation of the Re-Entry Values and Mindfulness Program (REVAMP) With Jail Inmates
- ClinicalTrials.gov ID
- NCT01378923
- Acronym / sponsor ID
- REVAMP / CCT-01
- Conditions
- Impulsive Behavior, Substance Abuse, HIV Risk Behavior, Anxiety, Depression, Criminogenic Thinking
- Keywords
- Mindfulness, Values, Jail Inmates, Impulsivity, Substance Abuse, HIV risk behavior, Anxiety, Depression
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- George Mason UniversityUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 23 Jun 2011 (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 is a pilot study to examine the acceptability and effectiveness of the Re-Entry Values and Mindfulness Program (REVAMP), a group intervention for jail inmates. It is hypothesized that REVAMP will reduce post-release recidivism, substance abuse, and HIV risk behavior.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Values-based mindfulness group | Experimental | Behavioral: REVAMPThe Re-entry values and mindfulness program (REVAMP) is an 8 session group intervention designed for jail inmates nearing release into the community |
| Treatment as usual | Other | Behavioral: TAUhas access to standard jail interventions and programs |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Must be 18 years or older
- Must be male
- Must be currently incarcerated jail inmate
- Must be sentenced
- Sentence must be short enough to serve out sentence at the Adult Detention Center
Key exclusion criteria (2 listed)
- Actively psychotic
- Assigned "keep separate" from other group members
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 |
|---|---|---|
| REVAMPThe Re-entry values and mindfulness program (REVAMP) is an 8 session group intervention designed for jail inmates nearing release into the community | Behavioural | Values-based mindfulness group |
| TAUhave access to standard jail programs and services | Behavioural | Treatment as usual |
Primary outcome
Recidivism - Self Report of undetected crimes
Time frame: 3 months post-release
Recidivism - Self Report of Arrests
Time frame: 3 months post-release
Recidivism - Official Records of arrests
Time frame: 3 months post-release
Substance Dependence symptoms - Texas Christian University (TCU) measure
Time frame: 3 months post-release
HIV Risk Behavior - Sex and Intravenous Drug Use (IDU) - TCU
Time frame: 3 months post-release
Acceptability - number of participants who report finding the treatment helpful and number who would recommend the treatment to a friend
Time frame: 1 week post-treatment
5 secondary outcomes
Mindfulness - Self report using Mindfulness Inventory: Nine Dimensions (MI:ND)
Time frame: 1 week post-treatment and 3 months post-release
Self Control - Self report using Brief Self control Scale (BSC)
Time frame: post-treatment and 3 months post-release
Self-Compassion - Self report using Neff's scale
Time frame: 1 week post-treatment and 3 months post-release
Distress-Driven Impulsivity - Behavioral measure using Balloon Analog Reaction Test (BART) preceded by mirror tracing task
Time frame: 1 week post-treatment
Psychological Symptoms - Self report using Personality Assessment Inventory
Time frame: 1 week post-treatment and 3 months post-release
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2013.
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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.
June P Tangney, PhD principal investigator
George Mason University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing REVAMP and TAU in people with Impulsive Behavior and Substance Abuse, run by George Mason University 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 8 inclusion and 2 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 7 May 2013. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Recidivism - Self Report of undetected crimes (time frame: 3 months post-release). The study lists 6 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 7 May 2013.