- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01438346
Behavioral Treatment for Substance Abuse
1. december 2016 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
38
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Utah
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Salt Lake City, Utah, Forenede Stater, 84102
- House of Hope
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Salt Lake City, Utah, Forenede Stater, 84112
- Pain Research Center, Anesthesiology, University of Utah
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 55 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / 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.
Andre navne:
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Eksperimentel: 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.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change from baseline in the measure of the Penn Alcohol and Craving Scale
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Subjective distress
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Yoshi Nakamura, Ph.D., University of Utah
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. august 2011
Primær færdiggørelse (Faktiske)
1. august 2012
Studieafslutning (Faktiske)
1. august 2012
Datoer for studieregistrering
Først indsendt
16. september 2011
Først indsendt, der opfyldte QC-kriterier
20. september 2011
Først opslået (Skøn)
22. september 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
2. december 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. december 2016
Sidst verificeret
1. december 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB00027696
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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