A Text Messaging Program to Help Prevent Early Opioid Relapse (PIER1)
2. mai 2017 oppdatert av: Brian Suffoletto, University of Pittsburgh
Feasibility and Acceptability of Using an Automated Text Messaging Program to Help Prevent Early Relapse Among Treatment-seeking Opioid Dependent Patients Discharged From the Emergency Department
The objective is to determine feasibility and acceptability of a text message (SMS)-based relapse prevention intervention as measured through: (1) study retention and SMS query completion rates and (2) participant ratings of PIER1 interest, perceived efficacy, and ease of use.
Methods: A mixed methods study of adult (age >=18) ED patients who seek treatment for opioids and have evidence of dependence based on Rapid Opioid Dependence Screen (RODS) score of >3 and are being discharged to outpatient (community) resources.
All participants receive standard of care in the ED, complete a baseline web survey, are asked to text with us for at least 7 days (up to a max of 28 days) and are asked to complete a follow-up phone call between day 8 and 14.
Investigators expect preliminary findings to support a relapse prevention intervention delivered through SMS.
Based on feedback from this mixed methods study, investigators plan to test a refined SMS program in a randomized trial.
Studieoversikt
Detaljert beskrivelse
The vast majority of those with opioid dependence do not receive treatment.
This may be due to the limited availability of existing treatment programs and to a range of societal and individual-level barriers, including the stigma associated with identifying oneself as a substance user and difficulty attending a treatment program on a regular basis.
Technology-based interventions have potential to help address these barriers and to expand access to evidence-based psychosocial treatment.
Automated, computer-based interventions have found high user acceptance and utilization and shown promise in treating substance use disorders.
The current study will evaluate a text-message-based psychosocial program called PIER1 (Preventing and Interrupting Early Relapse 1) when delivered to treatment-seeking opioid-dependent emergency department (ED) patients.
PIER1 is an interactive program based on the Relapse Prevention Model.
It is also informed by cognitive behavioral therapy and motivational interviewing.
Studietype
Intervensjonell
Registrering (Faktiske)
20
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Pennsylvania
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Pittsburgh, Pennsylvania, Forente stater, 15261
- University of Pittsburgh Medical Center Emergency Department
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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 60 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Age 18 - 60 years
- Seeking treatment for substance abuse (chief complaint of "detox")
- English speaking
- Opioid dependence (nursing history of opioid use + RODS score>3)
- Ownership of a mobile phone with text messaging
- Medically and psychologically stable (as determined by the clinician or investigator)
Exclusion Criteria:
- No mobile phone ownership or mobile phone without text messaging capabilities
- Incarcerated/in police custody
- Being treated for a self-inflicted injury or suicidal ideation (as determined by the clinician)
- Medical condition affecting cognition (as determined by the clinician or investigator's discretion)
- Unable to read, speak, or comprehend English (at the clinician or investigator's discretion)
- Patients who are under the influence of illicit drugs or alcohol (at the clinician or investigator's discretion)
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: PIER Intervention
The program will help participants learn to recognize the presence of craving and how it can be reduced through environmental, self-regulatory and mood management.
Each day, the PIER1 program sends (1) a morning reflection focused on positive thinking, (2) two random prompts assessing severity of craving, (3) feedback specific to managing withdrawal symptoms, mood management, and environmental triggers that are affecting craving, (4) evening assessments of drug use with feedback, (5) goal commitment prompt with feedback, and (6) user-triggered craving assessments with feedback
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Daily text message queries with tailored support
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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SMS query completion rate
Tidsramme: 7 days
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Investigators will report the percentage of SMS queries replied to over 7 days.
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7 days
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of intentional opioid uses
Tidsramme: 7 days
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Investigators will report the number of self-reported opioid use occasions.
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7 days
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Number of opioid overdoses
Tidsramme: 7 days
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Investigators will report the number of self-reported opioid overdoses.
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7 days
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Ratings of usefulness
Tidsramme: 7 days
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Investigators will report the median self-reported usefulness rating (0=not at all, 1=somewhat useful; 2=moderately useful; 3=very useful; 4=extremely useful
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7 days
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Brian Suffoletto, MD, University of Pittsburgh
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 2016
Primær fullføring (Faktiske)
1. desember 2016
Studiet fullført (Faktiske)
1. desember 2016
Datoer for studieregistrering
Først innsendt
6. juli 2016
Først innsendt som oppfylte QC-kriteriene
24. juli 2016
Først lagt ut (Anslag)
27. juli 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
5. mai 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. mai 2017
Sist bekreftet
1. mai 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PRO15120183
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Ja
IPD-planbeskrivelse
We will allow interested researchers access to a de-identified raw database
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. .
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