- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00840255
Brief Behavioral Treatment of Insomnia in Military Veterans: Phase 2 (BBTIMVII) (BBTIMVII)
15 giugno 2012 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
40
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Pennsylvania
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Pittsburgh, Pennsylvania, Stati Uniti, 15237
- Western Psychiatric Institute & Clinic
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore attivo: 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.
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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.
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Altro: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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Pittsburgh Sleep Quality Index (PSQI)
Lasso di tempo: Baseline and Post Intervention
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Baseline and Post Intervention
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Pittsburgh Sleep Diary
Lasso di tempo: Weekly
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Weekly
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PSQI Addendum for PTSD (PSQIA)
Lasso di tempo: Baseline and Post
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Baseline and Post
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Sleep Quality defined by: PIRS-20 and ISI
Lasso di tempo: Screening,Baseline, and Post
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Screening,Baseline, and Post
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
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PTSD symptom severity as measured by the CAPS
Lasso di tempo: Screening
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Screening
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Post Sleep Self Report: PSEQ-SV and POST
Lasso di tempo: Screening
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Screening
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Depression: BDI
Lasso di tempo: Baseline and Post
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Baseline and Post
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Anxiety: BAI
Lasso di tempo: Baseline and Post
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Baseline and Post
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Medical History: MHQ, MEDHIST_2WK, MOS
Lasso di tempo: Screening, Baseline, and Post
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Screening, Baseline, and Post
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Trauma History: THQ,CES,PCL-C,ICG
Lasso di tempo: Screening, Baseline, and Post
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Screening, Baseline, and Post
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Sleepiness: EPWORTH, BASS
Lasso di tempo: Screening, Baseline, and Post
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Screening, Baseline, and Post
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Mood and Behavior: BIS/BAS, SMITH, PANAS
Lasso di tempo: Screening, Baseline, and Post
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Screening, Baseline, and Post
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Expectations and Satisfaction: TEQ-94, Client Satisfaction Survey
Lasso di tempo: Baseline and Post
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Baseline and Post
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Anne Germain, PhD, University of Pittsburgh, Department of Psychiatry
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 aprile 2009
Completamento primario (Effettivo)
1 aprile 2012
Completamento dello studio (Effettivo)
1 aprile 2012
Date di iscrizione allo studio
Primo inviato
9 febbraio 2009
Primo inviato che soddisfa i criteri di controllo qualità
9 febbraio 2009
Primo Inserito (Stima)
10 febbraio 2009
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
18 giugno 2012
Ultimo aggiornamento inviato che soddisfa i criteri QC
15 giugno 2012
Ultimo verificato
1 giugno 2012
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- PRO08070327
- NIMH: 1 R34 MH080696
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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