Behavioral Treatment for Substance Abuse
1. desember 2016 oppdatert 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
38
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Utah
-
Salt Lake City, Utah, Forente stater, 84102
- House of Hope
-
Salt Lake City, Utah, Forente stater, 84112
- Pain Research Center, Anesthesiology, University of Utah
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 55 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
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.
|
10 weeks of usual care for substance abuse.
Andre navn:
|
|
Eksperimentell: 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.
|
Two sessions per week for 10 weeks, besides usual care treatment for substance abuse.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline in the measure of the Penn Alcohol and Craving Scale
Tidsramme: 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
|
Week 5 and Week 11
|
|
Change from baseline in Alcohol and Drug Use Consequences Scale
Tidsramme: 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
|
Week 5 and Week 11
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Subjective distress
Tidsramme: Pre (Baseline) Mid (Week 5), Post (Week 11)
|
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.
|
Pre (Baseline) Mid (Week 5), Post (Week 11)
|
|
Depression
Tidsramme: Pre (Baseline) Mid (Week 5), Post (Week 11)
|
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.
|
Pre (Baseline) Mid (Week 5), Post (Week 11)
|
|
Sleep
Tidsramme: Pre (Baseline) Mid (Week 5), Post (Week 11)
|
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.
|
Pre (Baseline) Mid (Week 5), Post (Week 11)
|
|
Mindfulness
Tidsramme: Pre (Baseline) Mid (Week 5), Post (Week 11)
|
The Five-facet Mindfulness Questionnaire (FFMQ) comprises five clear, interpretable facets of mindfulness: acting with awareness, observing, describing, non-judging, non-reacting.
|
Pre (Baseline) Mid (Week 5), Post (Week 11)
|
|
Self-Compassion
Tidsramme: Pre (Baseline) Mid (Week 5), Post (Week 11)
|
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).
|
Pre (Baseline) Mid (Week 5), Post (Week 11)
|
|
Well-being
Tidsramme: Weekly for 11 weeks
|
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.
|
Weekly for 11 weeks
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Yoshi Nakamura, Ph.D., University of Utah
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. august 2011
Primær fullføring (Faktiske)
1. august 2012
Studiet fullført (Faktiske)
1. august 2012
Datoer for studieregistrering
Først innsendt
16. september 2011
Først innsendt som oppfylte QC-kriteriene
20. september 2011
Først lagt ut (Anslag)
22. september 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
2. desember 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
1. desember 2016
Sist bekreftet
1. desember 2016
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IRB00027696
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .