- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01120067
Intensive Treatment for Chronic Pain and Posttraumatic Stress Disorder (PTSD)
Intensive Treatment of Chronic Pain and PTSD for OEF/OIF Veterans
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Objectives:
The primary objective of this study is to evaluate the efficacy of an intensive integrated treatment for Veterans with comorbid chronic pain and posttraumatic stress disorder (PTSD). A secondary objective is to examine potential mechanisms of action that might account for improvements in pain or PTSD. Third, exploratory analyses will be conducted to assess the relationship between participation in treatment and cognitive functioning. It is hypothesized that 1) participants receiving the intensive treatment (PT) will report significantly greater decreases in symptoms of pain and PTSD from pre-treatment to post-treatment when compared to participants randomized to a standard care (SC) condition, and 2) participants receiving PT will show greater maintenance of change on measures of pain and PTSD at 3 months following the completion of treatment when compared to participants randomized to the SC condition.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Connecticut
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West Haven, Connecticut, Forente stater, 06516
- VA Connecticut Healthcare System West Haven Campus, West Haven, CT
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Massachusetts
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Boston, Massachusetts, Forente stater, 02130
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
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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:
- Patients will be eligible to participate if they have constant pain of at least three months duration with a neurologic or musculoskeletal etiology.
- Patients must also meet diagnostic criteria for PTSD.
Exclusion Criteria:
- Patients with life threatening or acute physical illness, current alcohol or substance abuse, current psychosis or suicidal ideation, and individuals seeking pain treatment such as surgical interventions will be excluded.
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 |
|---|---|
|
Eksperimentell: Intensive Treatment
Intensive 3 week treatment for pain and PTSD.
This includes elements of Cognitive Processing Therapy and CBT for Chronic Pain
|
Participants randomized to the Intensive Treatment condition will attend 6 bi-weekly outpatient therapy sessions conducted in an individual format of 90 minutes in duration.
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Eksperimentell: Treatment as Usual
Treatment as Usual.
Participants are eligible for all treatment services as needed except for treatment of pain or PTSD
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Treatment as Usual.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
McGill Pain Questionnaire
Tidsramme: 6 months
|
McGill Pain Questionnaire (MPQ; Melzack, 1975): is a self-report questionnaire consisting of 102 words separated into three major classes; the sensory, affective, and evaluative aspects of pain.
Respondents are asked to circle the word that best describes their pain.
The stability, reliability, and validity of the MPQ have been established (Reading, Everitt, & Sledmere, 1982).
The MPQ total score ranges from 0 to 78 with higher values indicating more significant pain.
|
6 months
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: John Otis, BS BA PhD, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
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
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- D6281-I
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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