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Examining Written Disclosure as a Treatment for Post-Traumatic Stress Disorder

26. februar 2018 opdateret af: Denise M. Sloan, Boston University

Examining Written Disclosure as an Intervention for Posttraumatic Stress Disorder

This study will test the effectiveness of writing about a traumatic incident to treat post-traumatic stress disorder in people who have been in car accidents.

Studieoversigt

Status

Afsluttet

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

Interventionel

Tilmelding (Faktiske)

48

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02130
        • VA Boston Healthcare System, National Center for PTSD

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:

  • 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

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
Eksperimentel: Group 1 Treatment in Clinic
Participants will complete the written disclosure treatment in a clinic setting.
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:
  • Written Emotional Disclosure
  • Narrative Writing
  • Narrative Exposure
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:
  • Written Emotional Disclosure
  • Narrative Writing
  • Narrative Exposure
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.

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
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
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
Oswestry Disability Index
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
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
Last Day of Writing Questionnaire
Tidsramme: Measured after the last writing session
Measured after the last writing session
Follow-Up Writing Questionnaire
Tidsramme: Measured after the 3-month follow-up assessment
Measured after the 3-month follow-up assessment
Alcohol Use Disorders Identification Test
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
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

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

Efterforskere

  • Ledende efterforsker: Denise M. Sloan, PhD, VA Boston Healthcare System, National Center for PTSD; Boston University School of Medicine

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.

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 (Faktiske)

1. august 2008

Primær færdiggørelse (Faktiske)

1. august 2011

Studieafslutning (Faktiske)

1. august 2011

Datoer for studieregistrering

Først indsendt

16. marts 2009

Først indsendt, der opfyldte QC-kriterier

16. marts 2009

Først opslået (Skøn)

17. marts 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. februar 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. februar 2018

Sidst verificeret

1. februar 2018

Mere information

Begreber relateret til denne undersøgelse

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