Substance Use DisorderNCT01960036
Body-oriented Therapy for Women in SUD Treatment
A study testing Mindful Awareness in Body-oriented Therapy and Womens Health Education in people with Substance Use Disorder, run by University of Washington at 1 site in United States.
Trial summary
The long-term objective of this study is to improve women's substance use disorder (SUD) treatment. The immediate project goal is to test the efficacy of an innovative mind-body intervention, Mindful Awareness in Body-Oriented Therapy (MABT) to reduce substance use relapse among women in SUD treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Substance Use Disorder
- What is being tested?
- Mindful Awareness in Body-oriented Therapy and Womens Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to 30 Jun 2018
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) female, 2) enrolled in intensive outpatient (IOP) with at least 8 weeks remaining in planned SUD treatment program, 3) agrees to forgo (non-study) manual therapies (e.g.,massage) and mind-body therapies (e.g., mindfulness meditation) for 3 months (baseline to post-test); 4) willing to sign release for access of electronic medical records; 5) fluent in English; and 6) can attend MABT and WHE sessions when offered.
Who cannot join
- ) untreated psychotic diagnosis or symptoms, using modules from the MINI International Neuropsychiatric Interview; 2) unwilling or unable to remain in treatment for the duration of the trial (includes planned relocation, pending incarceration, planned surgical procedures, etc.); 3) cognitive impairment, to be assessed with an informed consent quiz, followed by the Mini-Mental Status Exam (MMSE), a common screening tool in SUD treatment studies, if there is demonstrated difficulty comprehending the consent; or 4) currently pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Body-oriented Therapy for Womens Substance Use Disorder Treatment
The long-term objective of this study is to improve women's substance use disorder (SUD) treatment. The immediate project goal is to test the efficacy of an innovative mind-body intervention, Mindful Awareness in Body-Oriented Therapy (MABT) to reduce substance use relapse among women in SUD treatment.
A novel mind-body approach, MABT combines a hands-on (manual) approach with mind-body psycho-education approaches of interoceptive training and mindfulness to develop somatically-based self-care skills and to facilitate emotion regulation. A three-group, randomized clinical trial using repeated measures, this project will enroll and randomize 225 women to one of three groups, MABT + Treatment-as-usual (TAU) (n=75), TAU only (n=75), and Women's Health Education (WHE) + TAU (to control for time and attention) (n=75). Study conditions will be compared at baseline, post-intervention, and at 6 and 12 month follow-up.
The primary aim is to test the hypothesis that MABT will result in reduced substance use and related health outcomes compared to TAU and to WHE+ TAU at 12 month follow-up. The second aim is to examine hypothesized underlying mechanisms of MABT. Female outpatients in two diverse community treatment facilities, serving racially diverse patients, will be recruited for study participation. This study builds on promising preliminary evidence of MABT feasibility and acceptability in substance use disorder treatment for women, and addresses the need for more clinical research aimed at improving SUD treatment outcomes for women.
- Conditions
- Substance Use Disorder
- Being tested
- Mindful Awareness in Body-oriented Therapy, Womens Health Education
- Keywords
- Substance Use Disorders, Complementary Therapies, Women, Mind-Body Therapies, Behavior and Behavior Mechanisms
- Medical subject headings
- Substance-Related Disorders, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful Awareness in Body-oriented TherapyBehavioural
Womens Health EducationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual (TAU) | No intervention | Usual intensive outpatient treatment for substance use disorders |
| Mindful Awareness in Body-oriented Therapy (MABT) | Experimental | A mind-body intervention to teach interoceptive skills for self-care. Receives: Behavioral: Mindful Awareness in Body-oriented Therapy |
| Womens Health Education | Active comparator | A comparative arm to control for time and attention that involves education about the human body relevant to women's health. Receives: Behavioral: Womens Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timeline Follow-back Interview (TLFB)
Collects self-report substance use information using a calendar method
Measured: Change from baseline in TLFB assessed at different time points (3,6 and 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2013 (estimated)
- Study startJan 2014
- Primary completion15 Sep 2017
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisorderStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Cynthia Price, University of Washington
- Investigators
- Cynthia J Price, PhD, MA, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01960036
- Sponsor's protocol ID
- 46102-J
- Other IDs
- R01DA033324
- Status last verified
- Oct 2018
- First submitted
- 8 Oct 2013
- Last updated
- 12 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Price CJ, Wells EA, Donovan DM, Rue T. Mindful awareness in body-oriented therapy as an adjunct to women's substance use disorder treatment: a pilot feasibility study. J Subst Abuse Treat. 2012 Jul;43(1):94-107. doi: 10.1016/j.jsat.2011.09.016. Epub 2011 Nov 25.
PubMed 22119181Price CJ, Wells EA, Donovan DM, Brooks M. Implementation and acceptability of Mindful Awareness in Body-oriented Therapy in women's substance use disorder treatment. J Altern Complement Med. 2012 May;18(5):454-62. doi: 10.1089/acm.2011.0126. Epub 2012 Apr 23.
PubMed 22524991Price CJ, Crowell SE. Respiratory sinus arrhythmia as a potential measure in substance use treatment--outcome studies. Addiction. 2016 Apr;111(4):615-25. doi: 10.1111/add.13232. Epub 2016 Jan 5.
PubMed 26567088
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body-oriented Therapy for Womens Substance Use Disorder Treatment
- ClinicalTrials.gov ID
- NCT01960036
- Acronym / sponsor ID
- 46102-J
- Conditions
- Substance Use Disorder
- Keywords
- Substance Use Disorders, Complementary Therapies, Women, Mind-Body Therapies, Behavior and Behavior Mechanisms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jan 2014 (actual)
- Primary completion
- 15 Sep 2017 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 10 Oct 2013 (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 long-term objective of this study is to improve women's substance use disorder (SUD) treatment. The immediate project goal is to test the efficacy of an innovative mind-body intervention, Mindful Awareness in Body-Oriented Therapy (MABT) to reduce substance use relapse among women in SUD treatment.
A novel mind-body approach, MABT combines a hands-on (manual) approach with mind-body psycho-education approaches of interoceptive training and mindfulness to develop somatically-based self-care skills and to facilitate emotion regulation. A three-group, randomized clinical trial using repeated measures, this project will enroll and randomize 225 women to one of three groups, MABT + Treatment-as-usual (TAU) (n=75), TAU only (n=75), and Women's Health Education (WHE) + TAU (to control for time and attention) (n=75). Study conditions will be compared at baseline, post-intervention, and at 6 and 12 month follow-up.
The primary aim is to test the hypothesis that MABT will result in reduced substance use and related health outcomes compared to TAU and to WHE+ TAU at 12 month follow-up. The second aim is to examine hypothesized underlying mechanisms of MABT. Female outpatients in two diverse community treatment facilities, serving racially diverse patients, will be recruited for study participation. This study builds on promising preliminary evidence of MABT feasibility and acceptability in substance use disorder treatment for women, and addresses the need for more clinical research aimed at improving SUD treatment outcomes for women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual (TAU) | No intervention | –Usual intensive outpatient treatment for substance use disorders |
| Mindful Awareness in Body-oriented Therapy (MABT) | Experimental | Behavioral: Mindful Awareness in Body-oriented TherapyA mind-body intervention to teach interoceptive skills for self-care. |
| Womens Health Education | Active comparator | Behavioral: Womens Health EducationA comparative arm to control for time and attention that involves education about the human body relevant to women's health. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) female, 2) enrolled in intensive outpatient (IOP) with at least 8 weeks remaining in planned SUD treatment program, 3) agrees to forgo (non-study) manual therapies (e.g.,massage) and mind-body therapies (e.g., mindfulness meditation) for 3 months (baseline to post-test); 4) willing to sign release for access of electronic medical records; 5) fluent in English; and 6) can attend MABT and WHE sessions when offered.
Key exclusion criteria (1 listed)
- ) untreated psychotic diagnosis or symptoms, using modules from the MINI International Neuropsychiatric Interview; 2) unwilling or unable to remain in treatment for the duration of the trial (includes planned relocation, pending incarceration, planned surgical procedures, etc.); 3) cognitive impairment, to be assessed with an informed consent quiz, followed by the Mini-Mental Status Exam (MMSE), a common screening tool in SUD treatment studies, if there is demonstrated difficulty comprehending the consent; or 4) currently pregnant.
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 |
|---|---|---|
| Mindful Awareness in Body-oriented Therapy | Behavioural | Mindful Awareness in Body-oriented Therapy (MABT) |
| Womens Health Education | Behavioural | Womens Health Education |
Primary outcome
Timeline Follow-back Interview (TLFB)
Time frame: Change from baseline in TLFB assessed at different time points (3,6 and 12 months)
Collects self-report substance use information using a calendar method
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 12 Oct 2018.
- Background: PubMed 22119181Price CJ, Wells EA, Donovan DM, Rue T. Mindful awareness in body-oriented therapy as an adjunct to women's substance use disorder treatment: a pilot feasibility study. J Subst Abuse Treat. 2012 Jul;43(1):94-107. doi: 10.1016/j.jsat.2011.09.016. Epub 2011 Nov 25.
- Background: PubMed 22524991Price CJ, Wells EA, Donovan DM, Brooks M. Implementation and acceptability of Mindful Awareness in Body-oriented Therapy in women's substance use disorder treatment. J Altern Complement Med. 2012 May;18(5):454-62. doi: 10.1089/acm.2011.0126. Epub 2012 Apr 23.
- Background: PubMed 26567088Price CJ, Crowell SE. Respiratory sinus arrhythmia as a potential measure in substance use treatment--outcome studies. Addiction. 2016 Apr;111(4):615-25. doi: 10.1111/add.13232. Epub 2016 Jan 5.
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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.
Cynthia J Price, PhD, MA principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful Awareness in Body-oriented Therapy and Womens Health Education in people with Substance Use Disorder, run by University of Washington 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 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: finished, as of the sponsor's last update on 12 Oct 2018. 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?
Timeline Follow-back Interview (TLFB) (time frame: Change from baseline in TLFB assessed at different time points (3,6 and 12 months)). 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 NCT01960036, which also lists 3 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 12 Oct 2018.