- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00218725
Effectiveness of Cognitive Therapy for Suicide Attempters With Drug Dependence Disorder
Cognitive Therapy for Suicide Attempters With Drug Dependence Disorder
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 1
Kontakte und Standorte
Studienorte
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Pennsylvania
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Philadelphia, Pennsylvania, Vereinigte Staaten, 19104
- Psychopathology Research Unit-University of Pennsylvania
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Sonstiges: 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.
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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.
|
Sonstiges: 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.
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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.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Suicidal Attempts
Zeitfenster: Months 1, 3, 6, 12, 18, and 24
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Months 1, 3, 6, 12, 18, and 24
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Suicide Ideation
Zeitfenster: Months 1, 3, 6, 12, 18, and 24
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Months 1, 3, 6, 12, 18, and 24
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Depression
Zeitfenster: Months 1, 3, 6, 12, 18, and 24
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Months 1, 3, 6, 12, 18, and 24
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Hopelessness
Zeitfenster: Months 1, 3, 6, 12, 18, and 24
|
Months 1, 3, 6, 12, 18, and 24
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Substance Use
Zeitfenster: Months 1, 3, 6, 12, 18, and 24
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Months 1, 3, 6, 12, 18, and 24
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- P20MH071905-02 (US NIH Stipendium/Vertrag)
- DSIR 83-ATP (NCT00719979)
- 802439 (Andere Kennung: University of Pennsylvania IRB)
- FWA00003616
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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