- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00862498
Examining Written Disclosure as a Treatment for Post-Traumatic Stress Disorder
Examining Written Disclosure as an Intervention for Posttraumatic Stress Disorder
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Post-traumatic stress disorder (PTSD) is a chronic and debilitating disorder caused by experiencing a stressful or traumatic event. Although there is evidence that treatments for PTSD are effective, many people do not seek treatment or seek treatment only after their PTSD has become severe. This study will test a low-cost, brief, and easily implemented treatment that may encourage people to seek treatment for PTSD. The treatment, called written disclosure (WD), involves writing about the traumatic event that caused a person's PTSD. In this study, people who have PTSD as the result of a motor vehicle accident will test two versions of WD, one administered in a clinic and the other administered over the phone.
Participation in this study will last 5 weeks, with follow-up assessments continuing until 6 months after treatment. After screening, participants will be assigned to one of three conditions: WD treatment delivered in the clinic, WD treatment delivered via phone, and waitlist. The WD treatment involves five weekly writing sessions. During the first session, trauma reactions and the rationale for WD will be explained to all participants, and then participants will write for 30 minutes about their motor vehicle accident. The next four sessions will involve only writing for 30 minutes. For those receiving treatment in the clinic, a therapist will communicate directions and explanations to participants, and participants will have their heart rate activity recorded continuously for 5 minutes prior to writing and during the 30 minutes of writing. For those receiving treatment over the phone, explanations of the study will be provided in writing, and a study staff member will call participants before and after each writing session to ensure that participants understand the directions and are not experiencing any unexpected negative reactions after writing. Participants in the waitlist condition will not receive treatment for the first 4 months. After that period, they will be offered the WD treatment.
Assessments of all participants will occur at baseline, after treatment, and 3 months after treatment. Participants assigned to receive WD treatment, either in a clinic or via phone, will also be assessed 6 months after treatment. Assessments administered at these points will involve semi-structured clinical interviews, self-report questionnaires, and measures of mood-related symptoms. Participants receiving treatment will also complete self-report measurements of emotional response after each writing session and the Daily Experiences Questionnaire every day during the 5 weeks of treatment. Participants on the waitlist will also undergo assessments of suicidal thoughts and PTSD symptoms every 2 weeks.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
Massachusetts
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Boston, Massachusetts, Forenede Stater, 02130
- VA Boston Healthcare System, National Center for PTSD
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Primary diagnosis of post-traumatic stress disorder
- Involved in motor vehicle accident that occurred at least 3 months ago
Exclusion Criteria:
- Current diagnosis of mania, hypomania, bipolar depression, psychotic disorder, substance abuse disorder, or severe depression
- History of psychosis
- Active suicidality or history of two or more suicide gestures or attempts in the past year
- Significant cognitive impairment
- Current participation in a psychosocial treatment, such as individual or group therapy led by a clinician
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Group 1 Treatment in Clinic
Participants will complete the written disclosure treatment in a clinic setting.
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Five sessions, each spaced 1 week apart, during which participants are asked to write about their motor vehicle accident for 30 minutes.
The first session of the intervention also involves a description of common reactions to a motor vehicle accident and the rationale for this treatment.
Andre navne:
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Eksperimentel: Group 2 Treatment via telephone
Participants will complete the written disclosure treatment in their homes via telephone.
|
Five sessions, each spaced 1 week apart, during which participants are asked to write about their motor vehicle accident for 30 minutes.
The first session of the intervention also involves a description of common reactions to a motor vehicle accident and the rationale for this treatment.
Andre navne:
|
Ingen indgriben: Group 3 Waitlist
Individuals will be placed on a waitlist for a period of 4 months, during which they will receive a phone call every other week to assess their suicidal ideation and post-traumatic stress disorder symptom severity.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Clinician-Administered Posttraumatic Stress Disorder Scale
Tidsramme: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
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Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Beck Depression Inventory - Second Edition
Tidsramme: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
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Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
|
Posttraumatic Cognitions Inventory
Tidsramme: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
|
Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
|
Anxious Driving Questionnaire
Tidsramme: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
|
Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
|
Client Satisfaction Questionnaire
Tidsramme: Measured at the end of the last treatment session
|
Measured at the end of the last treatment session
|
Daily Experiences Questionnaire
Tidsramme: Measured every day during the 5-week treatment period
|
Measured every day during the 5-week treatment period
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Oswestry Disability Index
Tidsramme: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
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Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
|
Quality of Life Inventory
Tidsramme: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
|
Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
|
Self-Assessment Manikin
Tidsramme: Measured after each writing session
|
Measured after each writing session
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Last Day of Writing Questionnaire
Tidsramme: Measured after the last writing session
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Measured after the last writing session
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Follow-Up Writing Questionnaire
Tidsramme: Measured after the 3-month follow-up assessment
|
Measured after the 3-month follow-up assessment
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Alcohol Use Disorders Identification Test
Tidsramme: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
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Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
|
Posttraumatic Stress Disorder Checklist - Civilian Version
Tidsramme: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
|
Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Denise M. Sloan, PhD, VA Boston Healthcare System, National Center for PTSD; Boston University School of Medicine
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- H-27236
- R34MH077658 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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