- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT00862498
Examining Written Disclosure as a Treatment for Post-Traumatic Stress Disorder
Examining Written Disclosure as an Intervention for Posttraumatic Stress Disorder
Tutkimuksen yleiskatsaus
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
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Massachusetts
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Boston, Massachusetts, Yhdysvallat, 02130
- VA Boston Healthcare System, National Center for PTSD
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
---|---|
Kokeellinen: 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.
Muut nimet:
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Kokeellinen: Group 2 Treatment via telephone
Participants will complete the written disclosure treatment in their homes via telephone.
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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.
Muut nimet:
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Ei väliintuloa: 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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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
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Clinician-Administered Posttraumatic Stress Disorder Scale
Aikaikkuna: 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
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
---|---|
Beck Depression Inventory - Second Edition
Aikaikkuna: 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
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Posttraumatic Cognitions Inventory
Aikaikkuna: 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
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Anxious Driving Questionnaire
Aikaikkuna: 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
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Client Satisfaction Questionnaire
Aikaikkuna: Measured at the end of the last treatment session
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Measured at the end of the last treatment session
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Daily Experiences Questionnaire
Aikaikkuna: Measured every day during the 5-week treatment period
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Measured every day during the 5-week treatment period
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Oswestry Disability Index
Aikaikkuna: 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
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Quality of Life Inventory
Aikaikkuna: 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
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Self-Assessment Manikin
Aikaikkuna: Measured after each writing session
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Measured after each writing session
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Last Day of Writing Questionnaire
Aikaikkuna: Measured after the last writing session
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Measured after the last writing session
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Follow-Up Writing Questionnaire
Aikaikkuna: Measured after the 3-month follow-up assessment
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Measured after the 3-month follow-up assessment
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Alcohol Use Disorders Identification Test
Aikaikkuna: 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
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Posttraumatic Stress Disorder Checklist - Civilian Version
Aikaikkuna: 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
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Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: Denise M. Sloan, PhD, VA Boston Healthcare System, National Center for PTSD; Boston University School of Medicine
Julkaisuja ja hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- H-27236
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Yksittäisten osallistujien tietojen suunnitelma (IPD)
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