Behavioral Treatment for Substance Abuse
1 december 2016 uppdaterad av: Yoshio Nakamura, University of Utah
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
38
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Utah
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Salt Lake City, Utah, Förenta staterna, 84102
- House of Hope
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Salt Lake City, Utah, Förenta staterna, 84112
- Pain Research Center, Anesthesiology, University of Utah
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 55 år (Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Beskrivning
Inclusion Criteria:
- 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
Exclusion Criteria:
- Psychosis
- Suicide risk
- Dementia
- Significant withdrawal risk
- Severe, unstable depression
- Requires intensive mental health treatment
- Cognitive impairment
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Aktiv komparator: Substance Abuse Education (SED)
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.
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10 weeks of usual care for substance abuse.
Andra namn:
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Experimentell: Mind-body Bridging (MBB)
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.
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Two sessions per week for 10 weeks, besides usual care treatment for substance abuse.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change from baseline in the measure of the Penn Alcohol and Craving Scale
Tidsram: Week 5 and Week 11
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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
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Week 5 and Week 11
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Change from baseline in Alcohol and Drug Use Consequences Scale
Tidsram: Week 5 and Week 11
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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
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Week 5 and Week 11
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Subjective distress
Tidsram: Pre (Baseline) Mid (Week 5), Post (Week 11)
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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.
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Pre (Baseline) Mid (Week 5), Post (Week 11)
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Depression
Tidsram: Pre (Baseline) Mid (Week 5), Post (Week 11)
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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.
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Pre (Baseline) Mid (Week 5), Post (Week 11)
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Sleep
Tidsram: Pre (Baseline) Mid (Week 5), Post (Week 11)
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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.
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Pre (Baseline) Mid (Week 5), Post (Week 11)
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Mindfulness
Tidsram: Pre (Baseline) Mid (Week 5), Post (Week 11)
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The Five-facet Mindfulness Questionnaire (FFMQ) comprises five clear, interpretable facets of mindfulness: acting with awareness, observing, describing, non-judging, non-reacting.
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Pre (Baseline) Mid (Week 5), Post (Week 11)
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Self-Compassion
Tidsram: Pre (Baseline) Mid (Week 5), Post (Week 11)
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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).
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Pre (Baseline) Mid (Week 5), Post (Week 11)
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Well-being
Tidsram: Weekly for 11 weeks
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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.
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Weekly for 11 weeks
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Yoshi Nakamura, Ph.D., University of Utah
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 augusti 2011
Primärt slutförande (Faktisk)
1 augusti 2012
Avslutad studie (Faktisk)
1 augusti 2012
Studieregistreringsdatum
Först inskickad
16 september 2011
Först inskickad som uppfyllde QC-kriterierna
20 september 2011
Första postat (Uppskatta)
22 september 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
2 december 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
1 december 2016
Senast verifierad
1 december 2016
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IRB00027696
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
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