- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00475241
Exposure Therapy for Chronic PTSD: Efficacy and Mechanisms
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Effective treatments for PTSD are available, with exposure therapy (ET) programs, including Prolonged Exposure (PE), having the most empirical evidence for effectiveness (Rothbaum et al., 2000). However, among people receiving treatment for PTSD, many are not receiving psychotherapies with empirically proven efficacy. In one VA VISN, only 10% of PTSD specialist therapists reported using ET routinely (Rosen et al., 2004). They suggested that a lack of training and human resources to provide ET, as well as misconceptions about exposure therapy may drive the deficit. Training efforts would be substantially more cost-effective of the proven treatments could be delivered in group formats. Development and proof of efficacy of a group-based PE would provide far more veterans with access to a treatment that can truly foster recovery from the devastating impact of PTSD. This is a central goal of this proposal.
Little is known about the mechanisms through which PE leads to recovery. Delineation of its mechanisms is a critical step towards the development of treatment refinements to improve effectiveness and efficiency of the treatment. We plan to examine the potential roles of cognitive, psychophysiologic and neuroendocrine factors in symptom improvement. The mechanistic component will provide preliminary data on interactions between cognitive change (increased sense of self-competence and control over negative outcomes), psychophysiological habituation (reduced reactivity to trauma related stimuli), and reduced neuroendocrine sensitivity (reduced hypothalamic-pituitary-adrenal (HPA) axis reactivity). We predict that cognitive change, psychophysiological habituation and reduced HPA reactivity will all be related to symptom improvement with effective treatment.
Thirty-six OEF/OIF veterans with chronic PTSD of at least 3 months duration will be randomly assigned to 15 weeks of twice weekly PE-G or TAU. All veterans will receive psychobiological assessments at pre treatment, mid treatment, post treatment, 3 months and 6 months follow-up. Each of these assessments will include interview and self-report of symptoms (i.e., PTSD, depression, and general anxiety severity), self-report of PTSD-related cognitions, psychophysiological (i.e., heart rate, skin conductance, respiration, and end-tidal CO2) assessment during neutral and trauma scripts, and assessment of salivary cortisol during neutral and trauma scripts. Also, on the morning prior to each laboratory assessment, patients will collect salivary cortisol at the moment of waking and 30 and 45 minutes post-walking. The results from this study will be used as pilot data for VA Merit Award and NIMH R01 applications for larger follow-up studies.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
- Fase 3
Kontakter og plasseringer
Studiesteder
-
-
Michigan
-
Ann Arbor, Michigan, Forente stater, 48113
- VA Ann Arbor Healthcare System
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- OEF/OIF Veterans with combat related posttraumatic stress disorder (PTSD) or posttraumatic stress symptoms (PTSS) of at least 3 months duration with significant impairment (PSSI greater than or equal to 15).
Exclusion Criteria:
- Any current level of personality disorder or suicidal risk that in the judgment of the investigator makes it unlikely or contraindicated that the patient can adhere to the study regimen.
- Psychosis
- Alcohol or substance dependence in the past 3 months
- Working night-shifts
- Changes to psychoactive medication in the past 8 weeks
- Taking medication that makes HPA axis measures difficult to interpret
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Prolonged Exposure Therapy
Prolonged exposure therapy for PTSD
|
exposure-based treatment for PTSD
|
Aktiv komparator: Present Centered Therapy
Present centered therapy for PTSD
|
present focused coping and problem solving for PTSD
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Clinician Administered PTSD Scale (Pre & Posttreatment)
Tidsramme: PostTreatment (Week 12)
|
Clinician Administered PTSD Scale (CAPS) assesses PTSD symptom severity.
Scores range from 0 to 136 and higher scores represent more severe symptoms.
|
PostTreatment (Week 12)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Trauma Potentiated Startle
Tidsramme: PostTreatment (Week 12)
|
Psychophysiological reactivity will be assessed using electromyography collected using a Biopac MP-100 physiology. The potentiation is recorded using a difference score (trauma probe response minus non-trauma probe response). The unit of measure is µV. Higher is more response to trauma cue compared to non-trauma cue. |
PostTreatment (Week 12)
|
Cortisol Response to Awakening
Tidsramme: PostTreatment (Week 12)
|
Area under the curve for awakening, 30 min, and 45 minute salivary cortisol assays. Higher means more cortisol response to awakening detected. |
PostTreatment (Week 12)
|
Posttraumatic Cognitions Inventory
Tidsramme: PostTreatment (Week 12)
|
Self-report measure of trauma-related cognitions.
Range is 21-147.
Higher is more problematic trauma-related cognitions.
|
PostTreatment (Week 12)
|
Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Sripada RK, Rauch SA, Tuerk PW, Smith E, Defever AM, Mayer RA, Messina M, Venners M. Mild traumatic brain injury and treatment response in prolonged exposure for PTSD. J Trauma Stress. 2013 Jun;26(3):369-75. doi: 10.1002/jts.21813. Epub 2013 May 20.
- Sivakumar RK, Samy W, Pakpirom J, Songthamwat B, Karmakar MK. Ultrasound-guided selective trunk block: Evaluation of ipsilateral sensorimotor block dynamics, hemidiaphragmatic function and efficacy for upper extremity surgery. A single-centre cohort study. Eur J Anaesthesiol. 2022 Oct 1;39(10):801-809. doi: 10.1097/EJA.0000000000001736. Epub 2022 Aug 11.
- Rauch SAM, King AP, Liberzon I, Sripada RK. Changes in Salivary Cortisol During Psychotherapy for Posttraumatic Stress Disorder: A Pilot Study in 30 Veterans. J Clin Psychiatry. 2017 May;78(5):599-603. doi: 10.4088/JCP.15m10596.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
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
- CDA-2-010-06F
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