- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02808468
Brief Restructuring Intervention Following Trauma Exposure (BRITE)
25. juni 2020 opdateret af: Michele Bedard-Gilligan, University of Washington
Developing a Brief Early Cognitive Intervention for PTSD and Alcohol Misuse
The broad aim of this study is to develop and test a brief intervention that can be implemented in the immediate weeks following sexual assault to decrease likelihood of developing posttraumatic stress disorder (PTSD) or alcohol misuse.
The first phase of the study will enroll 6 women to complete a brief, cognitive therapy protocol and provide feedback on the intervention (open trial).
The second phase of the study will recruit 76 women to complete either the intervention (38 women) or assessment only (38 women) to test the effects of the intervention on both PTSD symptoms and alcohol use behavior as compared to natural recovery following assault.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Detaljeret beskrivelse
Following sexual assault a substantial number of victims will go on to develop posttraumatic stress disorder (PTSD) or alcohol use disorders (AUD), and development of these disorders is costly to both the victim and society as a whole.
Intervening early, in the initial weeks following sexual assault, can provide victims with coping strategies that can decrease the likelihood of developing chronic symptoms.
Cognitive approaches for treating symptoms of PTSD have strong empirical support with chronic presentation of symptoms.
Less is known about effective strategies for intervening acutely following sexual assault.
This project is designed to adapt existing empirically supported cognitive treatment principles for both PTSD and AUD symptoms to be delivered acutely (within 10 weeks of assault) in a brief one session format followed by 4 weekly coaching calls.
The first 6 participants enrolled will receive the intervention and provide us with feedback on strengths and weaknesses of the protocol to help us improve it (Open Trial).
In the next phase, the pilot testing phase, the study will enroll 38 women to complete the one session intervention followed by 4 once per week coaching calls.
Participants will then be assessed again for symptoms of PTSD and alcohol use behavior at 3 month follow-up.
This brief intervention group will be compared at the 3 month follow-up to a group of 38 women who receive weekly symptom monitoring only.
Thus, this research aims to provide information on the efficacy of the intervention compared to the natural recovery process.
This research is significant in its potential to use a very brief and easy to access treatment to decrease the development of chronic psychopathology in a high risk group of women.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
63
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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Washington
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Seattle, Washington, Forenede Stater, 98195
- University of Washington
-
-
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:
- Identifies as female
- Age > 18 years
- 2-10 weeks post sexual assault
PTSD symptoms related to recent sexual assault, specifically defined as a minimum of
1 reexperiencing, 1 avoidance, 2 negative alterations in mood/cognition, or 2 hyperarousal symptoms
- Drinking more than 3 drinks on one occasion in the last month and at least two reported negative consequences of alcohol use
- Capacity to provide informed consent
- English fluency
- No planned absences that they would be unable to complete 5 weeks of assessments and coaching calls
- Access to a telephone.
Exclusion Criteria:
- Acutely suicidal with intent/plan
- Exhibit current psychosis
- Previous non-response to an adequate trial (8 or more sessions) of Cognitive Processing Therapy (CPT)
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 |
---|---|
Aktiv komparator: Brief Cognitive Intervention
One in person session (90 minutes) of trauma focused cognitive therapy followed by 4 weekly coaching calls (20 minutes each) with the same study therapist
|
Cognitive strategies to help achieve balanced thinking around sexual assault and alcohol use
|
Ingen indgriben: Assessment Only
Assessment session followed by weekly completion of assessment measures
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Posttraumatic Stress Disorder Symptom Scale- Interview Version (PSS-I)
Tidsramme: 12 weeks
|
The PSS-I assesses symptoms of PTSD as defined by the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) and is administered at baseline and 3 month follow up to assess change in PTSD symptoms
|
12 weeks
|
Timeline Followback (TLFB)
Tidsramme: 12 weeks
|
The TLFB uses a calendar method to assess drinking frequency and quantity and will be administered at baseline and 3 month follow up to assess for change in drinking behavior.
|
12 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Drinking Inventory of Consequences (DrInC)
Tidsramme: 12 weeks
|
The DrInC will be included to assess alcohol use consequences.
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12 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Michele Bedard-Gilligan, PhD, University of Washington
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. marts 2015
Primær færdiggørelse (Faktiske)
1. februar 2020
Studieafslutning (Faktiske)
1. februar 2020
Datoer for studieregistrering
Først indsendt
17. juni 2016
Først indsendt, der opfyldte QC-kriterier
17. juni 2016
Først opslået (Skøn)
21. juni 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
29. juni 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. juni 2020
Sidst verificeret
1. juni 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- STUDY00003232
- 1R34AA022966-01A1 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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