- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00840255
Brief Behavioral Treatment of Insomnia in Military Veterans: Phase 2 (BBTIMVII) (BBTIMVII)
15. juni 2012 oppdatert av: Anne Germain, University of Pittsburgh
Treatment of Insomnia in Military Veterans:Phase 2
The purpose of this study is to adapt and test the effects of a 4-week behavioral treatment that targets chronic insomnia (lasting >1 month) in service members returning from Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF), finalizing a treatment manual.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Insomnia is one of the most common reasons for referral to mental health services in active duty personnel.
Chronic insomnia often persists post-deployment, contributes to poor mental and physical health outcomes, and requires targeted interventions.
Effective behavioral treatments of insomnia have not been adapted and tested for the treatment of chronic insomnia comorbid to combat-related mental disorders and stress reactions.
In addition, effective behavioral insomnia treatments are typically delivered over an 8-week period.
This format may not be easily exportable to primary and community care settings where military returnees and veterans seek help.
The goal is to adapt and test the effects of a 4-week behavioral treatment that targets chronic insomnia (lasting >1 month) in service members returning from Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF), and who present with the typical psychiatric comorbidities associated of combat-related anxiety and mood disorders and stress reactions.
We call this intervention the Brief Behavioral Treatment of Insomnia for Military Veterans (BBTI-MV).
The proposed study includes two phases.
The specific aims of Phase II are: (1) To explore the effects of BBTI-MV on sleep and daytime symptoms of psychiatric distress.
We anticipate that participants randomized to BBTI-MV will show a higher categorical response rate and remission for sleep symptoms than subjects randomized to IC. (2) To evaluate in a preliminary manner the durability of therapeutic gains and by conducting a naturalistic follow-up assessment six months post-treatment in responders.
(3) To explore whether the nature of combat-related experiences, time since deployment and since, return to the US, deployment theater, medication use and change in dosage, mood and anxiety or disorders affect sleep treatment adherence and outcomes.
Studietype
Intervensjonell
Registrering (Faktiske)
40
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Pennsylvania
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Pittsburgh, Pennsylvania, Forente stater, 15237
- Western Psychiatric Institute & Clinic
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Age is 18 years old and older
- Military returnees from OIF/OEF
Meet diagnostic criteria for chronic insomnia as defined by:
a. Complaint of sleep latency >30 minutes, or wake time after sleep onset >30 minutes, or Sleep Efficiency <85%, or a complaint of non-restorative sleep
- Frequency of insomnia complaint >3 times per week;
- Duration of insomnia complaint >1 month
- Associated with at least one daytime consequences
- If using sleep medications, medication and dosage have not been changed in the past month, and will remain unchanged for the duration of the acute treatment phase of the study (i.e., 4 weeks)
- If using other psychotropic medications, medication and dosage have not been changed in the past 2 months, and will remain unchanged for the duration of the acute treatment phase of the study (i.e., 4 weeks)
Exclusion Criteria:
- Active duty personnel, or reservists/national guards scheduled to re-deploy if their departure date is < 2 months from the consent date
- Untreated, current, and severe PTSD as determined on the SCID.
- Untreated, current, and severe Major Depressive Disorder as determined by the Structured Clinical Interview for DSM-IV and a score > 30 on the Beck Depression Inventory
- Psychotic or bipolar disorder
- Current substance or alcohol use disorder as determined by the SCID or by positive drug toxicology results
- Unstable medical condition
- Hospitalization in the previous 2 weeks for a medical condition or surgery for which recovery overlaps with the study onset and duration
- Seizure disorder or open skull brain injury.
- Current sleep disorders such as nightmare disorder, restless legs syndrome, or suspected sleep disorder requiring polysomnographic assessment, such as obstructive sleep apnea or periodic leg movements.
- Sleep apnea revealed during the screening sleep study.
- Pregnancy.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: Breif Behavioral Treatment of Insomnia
Effective behavioral insomnia treatments are typically delivered over an 8-week period.
This format may not be easily exportable to primary and community care settings where military returnees and veterans seek help.
The goal here is to test the effects of a 4-week behavioral treatment that targets chronic insomnia (lasting >1 month) in service members returning from Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF), and who present with the typical psychiatric comorbidities associated of combat-related anxiety and mood disorders and stress reactions.
|
Twenty participants will be randomized to BBTI-MV.
As previously described, the intervention will be delivered over 4 consecutive weeks, which include individual face-to-face visits on Weeks 1 and 3, and telephone appointments on Weeks 2 and 4. Interventions will be delivered at Western Psychiatric Institutes and Clinic.
If possible, (according to space availability), the face-to-face sessions may also be conducted at the VAPHS clinics or at Reserve and Veterans Centers locally and regionally to strengthen our relations with local care and services providers and centers, and to facilitate future collaborative efforts.
The duration of the first treatment visit is 45-minutes, and the follow-up visit on Week 3 will last no more than 30 minutes.
Brief (<20 minutes) telephone sessions will be conducted on Weeks 2 and 4.
|
Annen: Information Control
This arm of the study does not receive the Brief Behavioral Treatment for Insomnia.
This arm will act as the control arm.
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Participants will receive two brochures from the American Academy on Sleep Medicine of Sleep Hygiene and on Insomnia.
The therapists will read the content of the 2 brochures with participants, and discuss how the information provide relates to individual participants' sleep experiences.
No recommendations for altering sleep schedules will be made by the assigned therapist.
Participants will be instructed to read these two brochures over the course of the following week, and to consider how the information provided in the brochures related to their own sleep patterns
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Pittsburgh Sleep Quality Index (PSQI)
Tidsramme: Baseline and Post Intervention
|
Baseline and Post Intervention
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Pittsburgh Sleep Diary
Tidsramme: Weekly
|
Weekly
|
PSQI Addendum for PTSD (PSQIA)
Tidsramme: Baseline and Post
|
Baseline and Post
|
Sleep Quality defined by: PIRS-20 and ISI
Tidsramme: Screening,Baseline, and Post
|
Screening,Baseline, and Post
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
PTSD symptom severity as measured by the CAPS
Tidsramme: Screening
|
Screening
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Post Sleep Self Report: PSEQ-SV and POST
Tidsramme: Screening
|
Screening
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Depression: BDI
Tidsramme: Baseline and Post
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Baseline and Post
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Anxiety: BAI
Tidsramme: Baseline and Post
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Baseline and Post
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Medical History: MHQ, MEDHIST_2WK, MOS
Tidsramme: Screening, Baseline, and Post
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Screening, Baseline, and Post
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Trauma History: THQ,CES,PCL-C,ICG
Tidsramme: Screening, Baseline, and Post
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Screening, Baseline, and Post
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Sleepiness: EPWORTH, BASS
Tidsramme: Screening, Baseline, and Post
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Screening, Baseline, and Post
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Mood and Behavior: BIS/BAS, SMITH, PANAS
Tidsramme: Screening, Baseline, and Post
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Screening, Baseline, and Post
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Expectations and Satisfaction: TEQ-94, Client Satisfaction Survey
Tidsramme: Baseline and Post
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Baseline and Post
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Anne Germain, PhD, University of Pittsburgh, Department of Psychiatry
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. april 2009
Primær fullføring (Faktiske)
1. april 2012
Studiet fullført (Faktiske)
1. april 2012
Datoer for studieregistrering
Først innsendt
9. februar 2009
Først innsendt som oppfylte QC-kriteriene
9. februar 2009
Først lagt ut (Anslag)
10. februar 2009
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
18. juni 2012
Siste oppdatering sendt inn som oppfylte QC-kriteriene
15. juni 2012
Sist bekreftet
1. juni 2012
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PRO08070327
- NIMH: 1 R34 MH080696
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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