- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00840255
Brief Behavioral Treatment of Insomnia in Military Veterans: Phase 2 (BBTIMVII) (BBTIMVII)
15 juni 2012 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
40
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Pennsylvania
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Pittsburgh, Pennsylvania, Förenta staterna, 15237
- Western Psychiatric Institute & Clinic
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / 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.
|
Övrig: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Pittsburgh Sleep Quality Index (PSQI)
Tidsram: Baseline and Post Intervention
|
Baseline and Post Intervention
|
Pittsburgh Sleep Diary
Tidsram: Weekly
|
Weekly
|
PSQI Addendum for PTSD (PSQIA)
Tidsram: Baseline and Post
|
Baseline and Post
|
Sleep Quality defined by: PIRS-20 and ISI
Tidsram: Screening,Baseline, and Post
|
Screening,Baseline, and Post
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
PTSD symptom severity as measured by the CAPS
Tidsram: Screening
|
Screening
|
Post Sleep Self Report: PSEQ-SV and POST
Tidsram: Screening
|
Screening
|
Depression: BDI
Tidsram: Baseline and Post
|
Baseline and Post
|
Anxiety: BAI
Tidsram: Baseline and Post
|
Baseline and Post
|
Medical History: MHQ, MEDHIST_2WK, MOS
Tidsram: Screening, Baseline, and Post
|
Screening, Baseline, and Post
|
Trauma History: THQ,CES,PCL-C,ICG
Tidsram: Screening, Baseline, and Post
|
Screening, Baseline, and Post
|
Sleepiness: EPWORTH, BASS
Tidsram: Screening, Baseline, and Post
|
Screening, Baseline, and Post
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Mood and Behavior: BIS/BAS, SMITH, PANAS
Tidsram: Screening, Baseline, and Post
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Screening, Baseline, and Post
|
Expectations and Satisfaction: TEQ-94, Client Satisfaction Survey
Tidsram: Baseline and Post
|
Baseline and Post
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Anne Germain, PhD, University of Pittsburgh, Department of Psychiatry
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 april 2009
Primärt slutförande (Faktisk)
1 april 2012
Avslutad studie (Faktisk)
1 april 2012
Studieregistreringsdatum
Först inskickad
9 februari 2009
Först inskickad som uppfyllde QC-kriterierna
9 februari 2009
Första postat (Uppskatta)
10 februari 2009
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
18 juni 2012
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
15 juni 2012
Senast verifierad
1 juni 2012
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PRO08070327
- NIMH: 1 R34 MH080696
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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