Substance-Related DisordersNCT01438346
Behavioral Treatment for Substance Abuse
A study testing Substance Abuse Education and Mind-body Bridging in people with Substance-Related Disorders, run by University of Utah at 2 sites in United States.
Trial summary
This pilot project will evaluate a new mind-body intervention called Mind-Body Bridging (MBB) for reducing substance abuse problems in women who are undergoing a substance abuse treatment program. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Substance-Related Disorders
- What is being tested?
- Substance Abuse Education and Mind-body Bridging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2011to Aug 2012
- 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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Substance abuse or dependence
- Resident/day client in the House of Hope substance abuse treatment program
- Minimum stay in treatment at House of Hope for 3.5 months
- Fluent in English
Who cannot join
- Psychosis
- Suicide risk
- Dementia
- Significant withdrawal risk
- Severe, unstable depression
- Requires intensive mental health treatment
- Cognitive impairment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
House of Hope
Salt Lake City, Utah, 84102
Pain Research Center, Anesthesiology, University of Utah
Salt Lake City, Utah, 84112
About this study
Official title: A Pilot Study of Two Group-based Intervention Programs for Patients With Substance Abuse Problems
This pilot project will evaluate a new mind-body intervention called Mind-Body Bridging (MBB) for reducing substance abuse problems in women who are undergoing a substance abuse treatment program. The main hypothesis is that MBB will be more effective than the control (standard) intervention program in helping people reduce their craving for illicit substances and/or alcohol.
Read the detailed description
This is a randomized clinical pilot study in which MBB will be compared with a standard treatment program for substance abuse. Both groups will run concurrently over the course of a 10-week period, twice per week.
- Conditions
- Substance-Related Disorders
- Being tested
- Substance Abuse Education, Mind-body Bridging
- Keywords
- Substance Abuse, Substance Addiction, Substance Dependence, Treatment program
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Substance Abuse EducationBehavioural
Also called Substance abuse usual care, Substance abuse treatment as usual
10 weeks of usual care for substance abuse.
Mind-body BridgingBehavioural
Also called Mind and Body Bridging Program
Two sessions per week for 10 weeks, besides usual care treatment for substance abuse.
| Study group | Role | What they receive |
|---|---|---|
| Substance Abuse Education (SED) | Active comparator | The Substance Abuse Education (SED) group will serve as the control intervention in which participants will receive instruction on a variety of topics included in the substance abuse treatment program curriculum. These will include, but are not limited to, information about anger management, smoking cessation, women's issues, and stress management, and approaches to help reduce cravings. Each week the TAU group will meet and a House of Hope (HOH) clinical staff member will discuss the above and related issues and how these may help individuals deal with their substance abuse and related psychological issues. Receives: Behavioral: Substance Abuse Education |
| Mind-body Bridging (MBB) | Experimental | Participants in the experimental Mind-Body Bridging (MBB) group, in addition to their usual treatment for substance abuse, will additionally receive instruction on the basics of MBB, and will learn MBB techniques to help deal with their cravings and comorbid psychological conditions. A workbook will be incorporated into the curriculum to provide MBB participants with daily exercises and activities to help facilitate adherence to the MBB program. Receives: Behavioral: Mind-body Bridging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the measure of the Penn Alcohol and Craving Scale
Change from baseline in the extent of drug and alcohol craving at Week 5 and Week 11, as measured by a modified version of the Penn Alcohol and Craving Scale
Measured: Week 5 and Week 11
Change from baseline in Alcohol and Drug Use Consequences Scale
Change from baseline in the measure of alcohol and drug consequences at Week 5 and Week 11, as measured by Alcohol and Drug Use Consequences Scale
Measured: Week 5 and Week 11
Secondary outcomes (6)
Subjective distress
Impact of Events Scale - Revised (IES-R) is a 22-item self-report measure that assesses subjective distress caused by traumatic events. The IES-R yields a total score (ranging from 0 to 88) and subscale scores can also be calculated for the Intrusion, Avoidance, and Hyperarousal subscales.
Measured: Pre (Baseline) Mid (Week 5), Post (Week 11)
Depression
The Center for Epidemiologic Studies Depression Scale is one of the most common screening tests to determine an individual's depression quotient. The test measures depressive feelings and behaviors during the past week.
Measured: Pre (Baseline) Mid (Week 5), Post (Week 11)
Sleep
The Medical Outcomes Study Sleep Scale (MOS-SS) provides an index of sleep problems and incorporates six sleep scale scores: 1) sleep disturbance, 2) sleep adequacy, 3) daytime somnolence, 4) snoring, 5) waking up short of breath with a headache, and 6) quantity of sleep. The MOS-SS is similar to the Pittsburgh Sleep Quality Index (PSQI) developed at the same time, which includes more questions about sleep disturbance with seven more items overall. The 1-week assessment is adapted from the normal 4-week retrospective assessment.
Measured: Pre (Baseline) Mid (Week 5), Post (Week 11)
Mindfulness
The Five-facet Mindfulness Questionnaire (FFMQ) comprises five clear, interpretable facets of mindfulness: acting with awareness, observing, describing, non-judging, non-reacting.
Measured: Pre (Baseline) Mid (Week 5), Post (Week 11)
Self-Compassion
Self compassion is measured by the Self-Compassion Scale that comprises 26 items. Self-compassion is an emotionally positive self-attitude that should protect against the negative consequences of self-judgment, isolation, and rumination (such as depression).
Measured: Pre (Baseline) Mid (Week 5), Post (Week 11)
Well-being
The Well-Being Index (WBI)is a 5-item scale developed and validated by the World Health Organization Collaborating Centre in Mental Health. The WBI will be used to assess whether participants show any changes in general well-being.
Measured: Weekly for 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2011 (estimated)
- Study startAug 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance-Related DisordersStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yoshio Nakamura, University of Utah
- Investigators
- Yoshi Nakamura, Ph.D., Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01438346
- Sponsor's protocol ID
- IRB00027696
- Status last verified
- Dec 2016
- First submitted
- 16 Sep 2011
- Last updated
- 2 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Two Group-based Intervention Programs for Patients With Substance Abuse Problems
- ClinicalTrials.gov ID
- NCT01438346
- Acronym / sponsor ID
- IRB00027696
- Conditions
- Substance-Related Disorders
- Keywords
- Substance Abuse, Substance Addiction, Substance Dependence, Treatment program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 22 Sep 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 pilot project will evaluate a new mind-body intervention called Mind-Body Bridging (MBB) for reducing substance abuse problems in women who are undergoing a substance abuse treatment program. The main hypothesis is that MBB will be more effective than the control (standard) intervention program in helping people reduce their craving for illicit substances and/or alcohol.
Detailed description
This is a randomized clinical pilot study in which MBB will be compared with a standard treatment program for substance abuse. Both groups will run concurrently over the course of a 10-week period, twice per week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Substance Abuse Education (SED) | Active comparator | Behavioral: Substance Abuse EducationThe Substance Abuse Education (SED) group will serve as the control intervention in which participants will receive instruction on a variety of topics included in the substance abuse treatment program curriculum. These will include, but are not limited to, information about anger management, smoking cessation, women's issues, and stress management, and approaches to help reduce cravings. Each week the TAU group will meet and a House of Hope (HOH) clinical staff member will discuss the above and related issues and how these may help individuals deal with their substance abuse and related psychological issues. |
| Mind-body Bridging (MBB) | Experimental | Behavioral: Mind-body BridgingParticipants in the experimental Mind-Body Bridging (MBB) group, in addition to their usual treatment for substance abuse, will additionally receive instruction on the basics of MBB, and will learn MBB techniques to help deal with their cravings and comorbid psychological conditions. A workbook will be incorporated into the curriculum to provide MBB participants with daily exercises and activities to help facilitate adherence to the MBB program. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Substance abuse or dependence
- Resident/day client in the House of Hope substance abuse treatment program
- Minimum stay in treatment at House of Hope for 3.5 months
- Fluent in English
Key exclusion criteria (7 listed)
- Psychosis
- Suicide risk
- Dementia
- Significant withdrawal risk
- Severe, unstable depression
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 |
|---|---|---|
| Substance Abuse EducationAlso: Substance abuse usual care, Substance abuse treatment as usual10 weeks of usual care for substance abuse. | Behavioural | Substance Abuse Education (SED) |
| Mind-body BridgingAlso: Mind and Body Bridging ProgramTwo sessions per week for 10 weeks, besides usual care treatment for substance abuse. | Behavioural | Mind-body Bridging (MBB) |
Primary outcome
Change from baseline in the measure of the Penn Alcohol and Craving Scale
Time frame: Week 5 and Week 11
Change from baseline in the extent of drug and alcohol craving at Week 5 and Week 11, as measured by a modified version of the Penn Alcohol and Craving Scale
Change from baseline in Alcohol and Drug Use Consequences Scale
Time frame: Week 5 and Week 11
Change from baseline in the measure of alcohol and drug consequences at Week 5 and Week 11, as measured by Alcohol and Drug Use Consequences Scale
6 secondary outcomes
Subjective distress
Time frame: Pre (Baseline) Mid (Week 5), Post (Week 11)
Depression
Time frame: Pre (Baseline) Mid (Week 5), Post (Week 11)
Sleep
Time frame: Pre (Baseline) Mid (Week 5), Post (Week 11)
Mindfulness
Time frame: Pre (Baseline) Mid (Week 5), Post (Week 11)
Self-Compassion
Time frame: Pre (Baseline) Mid (Week 5), Post (Week 11)
Well-being
Time frame: Weekly for 11 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 2 Dec 2016.
- Individual participant dataSharing planned: No
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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.
Yoshi Nakamura, Ph.D. principal investigator
University of Utah
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Substance Abuse Education and Mind-body Bridging in people with Substance-Related Disorders, run by University of Utah at 2 sites 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 4 inclusion and 7 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 2 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Change from baseline in the measure of the Penn Alcohol and Craving Scale (time frame: Week 5 and Week 11). The study lists 2 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 2 Dec 2016.