Chronic InsomniaBBTIMVIINCT00840255
Brief Behavioral Treatment of Insomnia in Military Veterans: Phase 2 (BBTIMVII)
A study testing BBTI-MV in people with Chronic Insomnia, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Insomnia
- What is being tested?
- BBTI-MV
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age is 18 years old and older
- Military returnees from OIF/OEF
- Meet diagnostic criteria for chronic insomnia as defined by:
- 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
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- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Western Psychiatric Institute & Clinic
Pittsburgh, Pennsylvania, 15237
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Insomnia
- Being tested
- BBTI-MV, Information Control
- Keywords
- Chronic Insomnia lasting more than 1 month
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BBTI-MVBehavioural
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 ControlOther
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
| Study group | Role | What they receive |
|---|---|---|
| Breif Behavioral Treatment of Insomnia | Active comparator | 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. Receives: Behavioral: BBTI-MV |
| Information Control | Other | This arm of the study does not receive the Brief Behavioral Treatment for Insomnia. This arm will act as the control arm. Receives: Other: Information Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Diary
Measured: Weekly
Pittsburgh Sleep Quality Index (PSQI)
Measured: Baseline and Post Intervention
PSQI Addendum for PTSD (PSQIA)
Measured: Baseline and Post
Sleep Quality defined by: PIRS-20 and ISI
Measured: Screening,Baseline, and Post
Secondary outcomes (9)
PTSD symptom severity as measured by the CAPS
Measured: Screening
Depression: BDI
Measured: Baseline and Post
Anxiety: BAI
Measured: Baseline and Post
Medical History: MHQ, MEDHIST_2WK, MOS
Measured: Screening, Baseline, and Post
Trauma History: THQ,CES,PCL-C,ICG
Measured: Screening, Baseline, and Post
Post Sleep Self Report: PSEQ-SV and POST
Measured: Screening
Sleepiness: EPWORTH, BASS
Measured: Screening, Baseline, and Post
Mood and Behavior: BIS/BAS, SMITH, PANAS
Measured: Screening, Baseline, and Post
Expectations and Satisfaction: TEQ-94, Client Satisfaction Survey
Measured: Baseline and Post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2009 (estimated)
- Study startApr 2009
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic InsomniaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Anne Germain, University of Pittsburgh
- Investigators
- Anne Germain, PhD, Principal investigator, University of Pittsburgh, Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00840255
- Sponsor's protocol ID
- PRO08070327
- Other IDs
- NIMH: 1 R34 MH080696
- Acronym
- BBTIMVII
- Status last verified
- Jun 2012
- First submitted
- 9 Feb 2009
- Last updated
- 18 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25194223
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Insomnia in Military Veterans:Phase 2
- ClinicalTrials.gov ID
- NCT00840255
- Acronym / sponsor ID
- BBTIMVII / PRO08070327
- Conditions
- Chronic Insomnia
- Keywords
- Chronic Insomnia lasting more than 1 month
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 10 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breif Behavioral Treatment of Insomnia | Active comparator | Behavioral: BBTI-MVEffective 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. |
| Information Control | Other | Other: Information ControlThis arm of the study does not receive the Brief Behavioral Treatment for Insomnia. This arm will act as the control arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age is 18 years old and older
- Military returnees from OIF/OEF
- Meet diagnostic criteria for chronic insomnia as defined by:
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BBTI-MVTwenty 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. | Behavioural | Breif Behavioral Treatment of Insomnia |
| Information ControlParticipants 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 | Other | Information Control |
Primary outcome
Pittsburgh Sleep Diary
Time frame: Weekly
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline and Post Intervention
PSQI Addendum for PTSD (PSQIA)
Time frame: Baseline and Post
Sleep Quality defined by: PIRS-20 and ISI
Time frame: Screening,Baseline, and Post
9 secondary outcomes
PTSD symptom severity as measured by the CAPS
Time frame: Screening
Depression: BDI
Time frame: Baseline and Post
Anxiety: BAI
Time frame: Baseline and Post
Medical History: MHQ, MEDHIST_2WK, MOS
Time frame: Screening, Baseline, and Post
Trauma History: THQ,CES,PCL-C,ICG
Time frame: Screening, Baseline, and Post
Post Sleep Self Report: PSEQ-SV and POST
Time frame: Screening
Sleepiness: EPWORTH, BASS
Time frame: Screening, Baseline, and Post
Mood and Behavior: BIS/BAS, SMITH, PANAS
Time frame: Screening, Baseline, and Post
Expectations and Satisfaction: TEQ-94, Client Satisfaction Survey
Time frame: Baseline and Post
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2012.
- Derived from this study: PubMed 25194223Germain 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Germain, PhD principal investigator
University of Pittsburgh, Department of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BBTI-MV in people with Chronic Insomnia, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Diary (time frame: Weekly). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00840255, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2012.