- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00840255
Brief Behavioral Treatment of Insomnia in Military Veterans: Phase 2 (BBTIMVII) (BBTIMVII)
15. Juni 2012 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
40
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Pennsylvania
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Pittsburgh, Pennsylvania, Vereinigte Staaten, 15237
- Western Psychiatric Institute & Clinic
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Aktiver 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.
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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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Sonstiges: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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Pittsburgh Sleep Quality Index (PSQI)
Zeitfenster: Baseline and Post Intervention
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Baseline and Post Intervention
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Pittsburgh Sleep Diary
Zeitfenster: Weekly
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Weekly
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PSQI Addendum for PTSD (PSQIA)
Zeitfenster: Baseline and Post
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Baseline and Post
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Sleep Quality defined by: PIRS-20 and ISI
Zeitfenster: Screening,Baseline, and Post
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Screening,Baseline, and Post
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
PTSD symptom severity as measured by the CAPS
Zeitfenster: Screening
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Screening
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Post Sleep Self Report: PSEQ-SV and POST
Zeitfenster: Screening
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Screening
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Depression: BDI
Zeitfenster: Baseline and Post
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Baseline and Post
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Anxiety: BAI
Zeitfenster: Baseline and Post
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Baseline and Post
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Medical History: MHQ, MEDHIST_2WK, MOS
Zeitfenster: Screening, Baseline, and Post
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Screening, Baseline, and Post
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Trauma History: THQ,CES,PCL-C,ICG
Zeitfenster: Screening, Baseline, and Post
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Screening, Baseline, and Post
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Sleepiness: EPWORTH, BASS
Zeitfenster: Screening, Baseline, and Post
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Screening, Baseline, and Post
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Mood and Behavior: BIS/BAS, SMITH, PANAS
Zeitfenster: Screening, Baseline, and Post
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Screening, Baseline, and Post
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Expectations and Satisfaction: TEQ-94, Client Satisfaction Survey
Zeitfenster: Baseline and Post
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Baseline and Post
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Anne Germain, PhD, University of Pittsburgh, Department of Psychiatry
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Nützliche Links
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. April 2009
Primärer Abschluss (Tatsächlich)
1. April 2012
Studienabschluss (Tatsächlich)
1. April 2012
Studienanmeldedaten
Zuerst eingereicht
9. Februar 2009
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
9. Februar 2009
Zuerst gepostet (Schätzen)
10. Februar 2009
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
18. Juni 2012
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
15. Juni 2012
Zuletzt verifiziert
1. Juni 2012
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- PRO08070327
- NIMH: 1 R34 MH080696
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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