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Brief Behavioral Treatment of Insomnia in Military Veterans: Phase 1 (BBTIMV1)

Primary Purpose

Chronic Insomnia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Brief Behavioral Treatment for Insomnia

About this trial

This is an interventional treatment trial for Chronic Insomnia focused on measuring Chronic Insomnia lasting more than 1 month

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age is 18 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;
- b. Frequency of insomnia complaint >3 times per week;
- c. Duration of insomnia complaint >1 month
- d. 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 for re-deployment over the following eight months
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 traumatic 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.

Sites / Locations

Western Psychiatric Institute and Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Brief Behavioral Treatment for Insomnia

Outcomes

Primary Outcome Measures

Pittsburgh Sleep Diary

Pittsburgh Sleep Quality Index (PSQI)

PSQI Addendum for PTSD (PSQIA)

Sleep quality defined by:PIRS 20 and the ISI

Secondary Outcome Measures

PTSD symptom severity as measured by the CAPS

Depression: BDI

Anxiety: BAI

Medical History: MHQ, MEDHIST_2WK, MOS

Trauma History: THQ,CES,PCL-C,ICG

Post Sleep Self Report: PSEQ-SV and POST

Sleepiness: EPWORTH, BASS

Expectations and Satisfaction: TEQ-94, Client Satisfaction Survey

Full Information

NCT ID

NCT00679406

First Posted

May 14, 2008

Last Updated

June 15, 2012

Sponsor

University of Pittsburgh

Collaborators

National Institute of Mental Health (NIMH)

1. Study Identification

Unique Protocol Identification Number

NCT00679406

Brief Title

Brief Behavioral Treatment of Insomnia in Military Veterans: Phase 1

Acronym

BBTIMV1

Official Title

Treatment of Insomnia in Military Veterans:Phase 1

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Completed

Study Start Date

June 2008 (undefined)

Primary Completion Date

April 2009 (Actual)

Study Completion Date

April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Pittsburgh

Collaborators

National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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).

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 of this R34 Exploratory Clinical Research Grant 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. Phase I aims at iteratively adapting and refining a treatment manual for insomnia in OIF/OEF military returnees. Outcomes of interest include self-report, diary, and actigraphic sleep measures, as well as measures of PTSD, anxiety, and depression, and perceived physical health.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Insomnia

Keywords

Chronic Insomnia lasting more than 1 month

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Brief Behavioral Treatment for Insomnia

Intervention Type

Behavioral

Intervention Name(s)

Brief Behavioral Treatment for Insomnia

Other Intervention Name(s)

BBTI

Intervention Description

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.

Primary Outcome Measure Information:

Title

Pittsburgh Sleep Diary

Time Frame

Weekly during entire participation

Title

Pittsburgh Sleep Quality Index (PSQI)

Time Frame

Baseline and Post Intervention

Title

PSQI Addendum for PTSD (PSQIA)

Time Frame

Baseline and Post Intervention

Title

Sleep quality defined by:PIRS 20 and the ISI

Time Frame

Screening, Baseline, and Post Intervention

Secondary Outcome Measure Information:

Title

PTSD symptom severity as measured by the CAPS

Time Frame

Screening

Title

Depression: BDI

Time Frame

Baseline and Post Intervention

Title

Anxiety: BAI

Time Frame

Baseline and Post Intervention

Title

Medical History: MHQ, MEDHIST_2WK, MOS

Time Frame

Screening, Baseline, and Post Intervention

Title

Trauma History: THQ,CES,PCL-C,ICG

Time Frame

Screening, Baseline, and Post Intervention

Title

Post Sleep Self Report: PSEQ-SV and POST

Time Frame

Screening

Title

Sleepiness: EPWORTH, BASS

Time Frame

Screening, Baseline, and Post Intervention

Title

Expectations and Satisfaction: TEQ-94, Client Satisfaction Survey

Time Frame

Baseline and Post Intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age is 18 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; b. Frequency of insomnia complaint >3 times per week; c. Duration of insomnia complaint >1 month d. 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 for re-deployment over the following eight months 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 traumatic 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anne Germain, PhD.

Organizational Affiliation

University of Pittsburgh, Department of Psychiatry

Official's Role

Principal Investigator

Facility Information:

Facility Name

Western Psychiatric Institute and Clinic

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.veteranssleep.pitt.edu

Description

Sleep Studies for Military Veterans

Learn more about this trial

Brief Behavioral Treatment of Insomnia in Military Veterans: Phase 1

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