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Effectiveness of Cognitive Therapy for Suicide Attempters With Drug Dependence Disorder

28. september 2015 opdateret af: University of Pennsylvania

Cognitive Therapy for Suicide Attempters With Drug Dependence Disorder

This study will examine the effectiveness of combining cognitive therapy with enriched usual care for preventing subsequent suicide attempts in people with a drug dependence who have recently attempted suicide.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Suicide attempts involving drug abuse are a major public health problem. Development of interventions that focus on reducing the suicide attempt rate among drug abusers is a necessity. There is a strong connection between drug abuse and both suicide attempts and completed suicide. As much as 45% of drug abusers have attempted suicide at least once. The rate of completed suicide among drug abusers has been reported to be as much as 30 times the rate for the general population. Unfortunately, there is a lack of empirically supported treatments for reducing suicidal behavior in drug abusers. This study will develop and evaluate the effectiveness of a cognitive therapy intervention for people with a drug dependence disorder who recently attempted suicide.

Participants in this single-blind study will be randomly assigned to one of two treatment groups: cognitive therapy combined with enriched usual care; or enriched usual care alone. An initial baseline assessment will occur within 7 days following the participant's suicide attempt and subsequent medical evaluation at a hospital emergency department. Suicide behavior and ideation, depression, hopelessness, and addiction severity will be assessed. Following the baseline assessment, treatment will begin. The cognitive therapy treatment will be specifically developed to prevent suicide attempts. It will involve the identification of proximal thoughts, images, and core beliefs that were activated prior to the suicide attempt. Cognitive and behavioral strategies will be applied to address the identified thoughts and beliefs. Patients will also learn adaptive ways of coping with stressors. The enriched usual care will entail standard treatments for suicide prevention. Study visits will occur 1, 3, 6, 12, 18, and 24 months following enrollment. Baseline measurements will be repeated at each study visit to evaluate participants' improvement. Participants receiving cognitive therapy will attend approximately 10 weekly or bi-weekly outpatient study visits. Participation will last for 2 years.

For information on a related study, please follow this link:

http://clinicaltrials.gov/show/NCT00149773

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

2

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Psychopathology Research Unit-University of Pennsylvania

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Recent suicide attempt with an emergency department visit within 48 hours of the attempt (suicide attempt is considered to be a potentially self-injurious behavior with a nonfatal outcome for which there is evidence, either explicit or implicit, that the individual intended to kill himself or herself)
  • Current DSM-IV diagnosis of a current drug dependence disorder within the past 6 months

Exclusion Criteria:

  • Self-mutilating behavior without intent to commit suicide
  • An acute, unstable, or severe Axis III disorder that may affect participation

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: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Cognitive Therapy
The cognitive therapy intervention for suicide attempters has been designed to provide a brief, timely, flexible intervention that can be incorporated into general and psychiatric inpatient and outpatient services and applied to the population of patients who attempt suicide. A central feature of the intervention is the adaptation of cognitive therapy to the population of patients who attempt suicide. The focus of the intervention is the identification of core beliefs and key automatic thoughts that were elicited prior to and during the most recent suicide attempt. Once these beliefs and thoughts have been articulated, the counselor and patient develop more adaptive responses during an acute suicidal crisis.
Adfærdsmæssigt: Cognitive Therapy
The cognitive therapy intervention for suicide attempters has been designed to provide a brief, timely, flexible intervention that can be incorporated into general and psychiatric inpatient and outpatient services and applied to the population of patients who attempt suicide. A central feature of the intervention is the adaptation of cognitive therapy to the population of patients who attempt suicide. The focus of the intervention is the identification of core beliefs and key automatic thoughts that were elicited prior to and during the most recent suicide attempt. Once these beliefs and thoughts have been articulated, the counselor and patient develop more adaptive responses during an acute suicidal crisis.
Andet: Enriched Care
The Enriched Care condition will be used as the treatment comparison condition for this study. The Enriched Care condition consists of the usual care that patients may obtain in the community as well as the assessment and referral services provided by the case managers. Participation in the study does not restrict patients in any way in their access to other health care, and all patients in both conditions will be allowed to receive any additional mental health and substance abuse treatment in the community.
Andet: Enriched Care
The Enriched Care condition will be used as the treatment comparison condition for this study. The Enriched Care condition consists of the usual care that patients may obtain in the community as well as the assessment and referral services provided by the case managers. Participation in the study does not restrict patients in any way in their access to other health care, and all patients in both conditions will be allowed to receive any additional mental health and substance abuse treatment in the community.
Andre navne:
  • Sagsbehandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Suicidal Attempts
Tidsramme: Months 1, 3, 6, 12, 18, and 24
Months 1, 3, 6, 12, 18, and 24

Sekundære resultatmål

Resultatmål
Tidsramme
Suicide Ideation
Tidsramme: Months 1, 3, 6, 12, 18, and 24
Months 1, 3, 6, 12, 18, and 24
Depression
Tidsramme: Months 1, 3, 6, 12, 18, and 24
Months 1, 3, 6, 12, 18, and 24
Hopelessness
Tidsramme: Months 1, 3, 6, 12, 18, and 24
Months 1, 3, 6, 12, 18, and 24
Substance Use
Tidsramme: Months 1, 3, 6, 12, 18, and 24
Months 1, 3, 6, 12, 18, and 24

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Pennsylvania

Samarbejdspartnere

National Institute of Mental Health (NIMH)

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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. maj 2005

Primær færdiggørelse (Faktiske)

1. oktober 2005

Studieafslutning (Faktiske)

1. oktober 2005

Datoer for studieregistrering

Først indsendt

21. september 2005

Først indsendt, der opfyldte QC-kriterier

21. september 2005

Først opslået (Skøn)

22. september 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

29. september 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. september 2015

Sidst verificeret

1. september 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • P20MH071905-02 (U.S. NIH-bevilling/kontrakt)
  • DSIR 83-ATP (NCT00719979)
  • 802439 (Anden identifikator: University of Pennsylvania IRB)
  • FWA00003616

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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