Kortvarig langvarig eksponeringsterapi versus klinisk standard for å redusere posttraumatisk stress etter ryggmargsskade
Forebygging av posttraumatisk stress: En RCT av modifisert kortvarig forlenget eksponeringsterapi (Brief PE) under innleggelse i rehabilitering etter ryggmargsskade (SCI)
This study will examine the use brief prolonged exposure (Brief PE) therapy compared to standard clinical care to reduce posttraumatic distress among people who have had a spinal cord injury and are receiving rehabilitation in an inpatient setting.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
This is a prospective randomized controlled trial examining the efficacy of brief Prolonged Exposure Therapy (Brief PE) delivered in an inpatient rehabilitation setting post-SCI to reduce PTSD symptoms. The overall goal of this project is to test a Brief PE (three 60-minute sessions) to reduce psychological distress after SCI and to mitigate long-term post-SCI distress including PTSD as well as secondary health outcomes (including depression and general anxiety) at 1, 3, and 6 months from baseline. The intervention group (Brief PE) will be compared to standard clinical care with treatment as usual (TAU).
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
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Texas
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Dallas, Texas, Forente stater, 75204
- Kirstie A Jones
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- 18 years of age or older
- Admitted to the inpatient rehabilitation hospital diagnosed with a SCI following a traumatic event
Exclusion Criteria:
- Patients in police custody
- Not fluent in the English language
- Severe cognitive impairment
- Patients who are acutely suicidal
- Patients with active psychosis
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Placebo komparator: Treatment as Usual
Participants in the Treatment as Usual (TAU) group will not receive Prolonged Exposure therapy, but will instead receive the standard clinical treatment received by all persons with spinal cord injury (SCI) at the rehabilitation facility. TAU participants will complete questionnaires/interviews at 1, 3, and 6 months from Baseline. |
This may include an evaluation by a licensed psychologist and continued follow-up psychotherapy as needed. Treatment as usual participants will have follow-up assessments at 1, 3, and 6 months. |
|
Eksperimentell: Brief Prolonged Exposure
Experimental: Brief Prolonged Exposure Participants will receive Brief PE. Subjects in the Brief Prolonged Exposure (BPE) intervention group will additionally receive 3 total therapy sessions, each lasting about 60 minutes spaced about 1-7 days apart. Sessions include education about common reactions to trauma, breathing retraining, identification of self-care tasks and prolonged (repeated) imaginal exposure to trauma memories. Any missed sessions will be made up by scheduling multiple sessions in subsequent weeks. Individuals in the BPE group will complete a screener and then survey questionnaires/ interviews at 1, 3, and 6 months from Baseline. |
Brief PE will include 3 therapy sessions, each lasting approximately 60 minutes. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in PSSI-5: PTSD Symptom Scale - Interview for DSM-5
Tidsramme: Baseline, 1 month, 3 months ,6 months
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Change in PTSD symptoms from baseline to 6 months. Total scale ranges from 0-80 points. Higher score indicates greater severity of symptoms. |
Baseline, 1 month, 3 months ,6 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Patient Health Questionnaire-9
Tidsramme: Baseline, 1 month, 3 months ,6 months
|
Change in depressed mood from baseline to 6 months. Scored on a 0-27 scale. Higher score indicates greater severity of issues. |
Baseline, 1 month, 3 months ,6 months
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Change in Generalized Anxiety Disorder-7 Item
Tidsramme: Time Frame: Baseline, 1 month, 3 months, 6 months
|
Change in anxiety scored using a 0-21 scale. Higher score indicates greater anxiety. |
Time Frame: Baseline, 1 month, 3 months, 6 months
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Ann Maria Warren, PhD, Baylor Scott and White Research Institute-Trauma
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 021-339
Plan for individuelle deltakerdata (IPD)
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