Back to results

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

Primary Purpose

Chronic Insomnia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

BBTI-MV

Information Control

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 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.

Sites / Locations

Western Psychiatric Institute & Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Breif Behavioral Treatment of Insomnia

Information Control

Arm 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.

This arm of the study does not receive the Brief Behavioral Treatment for Insomnia. This arm will act as the control arm.

Outcomes

Primary Outcome Measures

Pittsburgh Sleep Diary

Pittsburgh Sleep Quality Index (PSQI)

PSQI Addendum for PTSD (PSQIA)

Sleep Quality defined by: PIRS-20 and 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

Mood and Behavior: BIS/BAS, SMITH, PANAS

Expectations and Satisfaction: TEQ-94, Client Satisfaction Survey

Full Information

NCT ID

NCT00840255

First Posted

February 9, 2009

Last Updated

June 15, 2012

Sponsor

University of Pittsburgh

Collaborators

National Institute of Mental Health (NIMH)

1. Study Identification

Unique Protocol Identification Number

NCT00840255

Brief Title

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

Acronym

BBTIMVII

Official Title

Treatment of Insomnia in Military Veterans:Phase 2

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Completed

Study Start Date

April 2009 (undefined)

Primary Completion Date

April 2012 (Actual)

Study Completion Date

April 2012 (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), finalizing a treatment manual.

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.

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

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Breif Behavioral Treatment of Insomnia

Arm Type

Active Comparator

Arm Description

Arm Title

Information Control

Arm Type

Other

Arm Description

This arm of the study does not receive the Brief Behavioral Treatment for Insomnia. This arm will act as the control arm.

Intervention Type

Behavioral

Intervention Name(s)

BBTI-MV

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Information Control

Intervention Description

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

Primary Outcome Measure Information:

Title

Pittsburgh Sleep Diary

Time Frame

Weekly

Title

Pittsburgh Sleep Quality Index (PSQI)

Time Frame

Baseline and Post Intervention

Title

PSQI Addendum for PTSD (PSQIA)

Time Frame

Baseline and Post

Title

Sleep Quality defined by: PIRS-20 and ISI

Time Frame

Screening,Baseline, and Post

Secondary Outcome Measure Information:

Title

PTSD symptom severity as measured by the CAPS

Time Frame

Screening

Title

Depression: BDI

Time Frame

Baseline and Post

Title

Anxiety: BAI

Time Frame

Baseline and Post

Title

Medical History: MHQ, MEDHIST_2WK, MOS

Time Frame

Screening, Baseline, and Post

Title

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

Time Frame

Screening, Baseline, and Post

Title

Post Sleep Self Report: PSEQ-SV and POST

Time Frame

Screening

Title

Sleepiness: EPWORTH, BASS

Time Frame

Screening, Baseline, and Post

Title

Mood and Behavior: BIS/BAS, SMITH, PANAS

Time Frame

Screening, Baseline, and Post

Title

Expectations and Satisfaction: TEQ-94, Client Satisfaction Survey

Time Frame

Baseline and Post

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

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 & Clinic

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15237

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

25194223

Citation

Germain A, Richardson R, Stocker R, Mammen O, Hall M, Bramoweth AD, Begley A, Rode N, Frank E, Haas G, Buysse DJ. Treatment for insomnia in combat-exposed OEF/OIF/OND military veterans: preliminary randomized controlled trial. Behav Res Ther. 2014 Oct;61:78-88. doi: 10.1016/j.brat.2014.07.016. Epub 2014 Aug 12.

Results Reference

derived

Links:

URL

http://www.veteranssleep.pitt.edu

Description

Pittsburgh Veterans Sleep Studies

Learn more about this trial

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

We'll reach out to this number within 24 hrs