Brief Behavioral Treatment of Insomnia in Military Veterans: Phase 2 (BBTIMVII)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Anne Germain, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00840255
First received: February 9, 2009
Last updated: June 15, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Chronic Insomnia
Behavioral: BBTI-MV
Other: Information Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Insomnia in Military Veterans:Phase 2

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Pittsburgh Sleep Diary [ Time Frame: Weekly ] [ Designated as safety issue: No ]
  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline and Post Intervention ] [ Designated as safety issue: No ]
  • PSQI Addendum for PTSD (PSQIA) [ Time Frame: Baseline and Post ] [ Designated as safety issue: No ]
  • Sleep Quality defined by: PIRS-20 and ISI [ Time Frame: Screening,Baseline, and Post ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PTSD symptom severity as measured by the CAPS [ Time Frame: Screening ] [ Designated as safety issue: Yes ]
  • Depression: BDI [ Time Frame: Baseline and Post ] [ Designated as safety issue: No ]
  • Anxiety: BAI [ Time Frame: Baseline and Post ] [ Designated as safety issue: No ]
  • Medical History: MHQ, MEDHIST_2WK, MOS [ Time Frame: Screening, Baseline, and Post ] [ Designated as safety issue: No ]
  • Trauma History: THQ,CES,PCL-C,ICG [ Time Frame: Screening, Baseline, and Post ] [ Designated as safety issue: No ]
  • Post Sleep Self Report: PSEQ-SV and POST [ Time Frame: Screening ] [ Designated as safety issue: No ]
  • Sleepiness: EPWORTH, BASS [ Time Frame: Screening, Baseline, and Post ] [ Designated as safety issue: No ]
  • Mood and Behavior: BIS/BAS, SMITH, PANAS [ Time Frame: Screening, Baseline, and Post ] [ Designated as safety issue: No ]
  • Expectations and Satisfaction: TEQ-94, Client Satisfaction Survey [ Time Frame: Baseline and Post ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: April 2009
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Behavioral: BBTI-MV
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.
Information Control
This arm of the study does not receive the Brief Behavioral Treatment for Insomnia. This arm will act as the control arm.
Other: Information Control
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age is 18 years old and older
  2. Military returnees from OIF/OEF
  3. 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
  4. 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)
  5. 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:

  1. Active duty personnel, or reservists/national guards scheduled to re-deploy if their departure date is < 2 months from the consent date
  2. Untreated, current, and severe PTSD as determined on the SCID.
  3. 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
  4. Psychotic or bipolar disorder
  5. Current substance or alcohol use disorder as determined by the SCID or by positive drug toxicology results
  6. Unstable medical condition
  7. Hospitalization in the previous 2 weeks for a medical condition or surgery for which recovery overlaps with the study onset and duration
  8. Seizure disorder or open skull brain injury.
  9. 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.
  10. Sleep apnea revealed during the screening sleep study.
  11. Pregnancy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00840255

Locations
United States, Pennsylvania
Western Psychiatric Institute & Clinic
Pittsburgh, Pennsylvania, United States, 15237
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Anne Germain, PhD University of Pittsburgh, Department of Psychiatry
  More Information

Additional Information:
No publications provided

Responsible Party: Anne Germain, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00840255     History of Changes
Other Study ID Numbers: PRO08070327, NIMH: 1 R34 MH080696
Study First Received: February 9, 2009
Last Updated: June 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Chronic Insomnia lasting more than 1 month

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on September 14, 2014