Insomnia DisorderBBTINCT02571452

Brief Behavioral Insomnia Treatment Study

A study testing Brief Behavioral Treatment for Insomnia and Progressive Muscle Relaxation in people with Insomnia Disorder, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine whether a brief, behavioral treatment for insomnia is effective in addressing social and occupational functioning and overall health among Veterans with insomnia disorder. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Insomnia Disorder
What is being tested?: Brief Behavioral Treatment for Insomnia and Progressive Muscle Relaxation
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 93 participants
Where: 1 siteUnited States
Study dates: 6 Jan 2016to 30 Jun 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Veterans between the ages of 18-75 years.
Meet DSM-5 Criteria for Insomnia Disorder.
Able attend in-person appointments at the San Francisco VA Medical Center
The investigators will not exclude individuals who are taking insomnia or antidepressant medications, provided they have been stable on these medications for at least one month and still meet criteria for Insomnia Disorder as described above.
Specifically, individuals receiving benzodiazepine or benzodiazepine receptor agonists, anticonvulsants, atypical antipsychotic medication, or non-SSRI antidepressant medications such as trazodone will not be excluded provided they meet the criteria described above.
The investigators will not exclude Veterans receiving any type of psychotherapy, provided they have received this treatment for at least three months and do not plan to discontinue this treatment during the BBTI trial.

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However, individual who need to start a new type of psychotherapy during the course of the treatment will be excluded, or they will need to wait three months in order to enroll in the trial.
The investigators will not exclude individuals with TBI.
The investigators will not exclude individuals with chronic pain.
The investigators will not exclude individuals based on any other mental health condition, including posttraumatic stress disorder and depression.

Who cannot join

Conditions that may be associated with comorbid insomnia, including a lifetime history of any psychiatric disorder with psychotic features or bipolar disorder, and alcohol or drug dependence within the past year.
Individuals who meet criteria for alcohol or drug abuse will be asked to reduce alcohol to recommended limits during the course of the study and/or refrain from drug use in order to be included.
Veterans with suicidal or homicidal ideation.
Veterans who are pregnant, due to the biological impact of pregnancy on sleep.
Veterans who work night or rotating shifts.
Veterans with untreated moderate to severe sleep apnea (those receiving treatment will not be excluded from the study).

Trial locations and contacts

1 site in 1 country.

United States1 site

San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, 94121

Other trials in United States

About this study

Official title: Telephone-Facilitated Insomnia Treatment in Primary Care for OEF/OIF/OND Veterans

Read the detailed description

This study is a randomized, controlled trial of a telephone-based, brief insomnia treatment in primary care in order to accomplish the goal of improving psychosocial functioning in Veterans who meet criteria for Insomnia Disorder. The primary outcome for the trial will be psychosocial functioning, with insomnia severity serving as the secondary outcome. Additional goals include evaluating durability of treatment gains and obtaining feedback from participants about the utility and feasibility of the proposed insomnia treatment.

Conditions: Insomnia Disorder
Being tested: Brief Behavioral Treatment for Insomnia, Progressive Muscle Relaxation
Keywords: Veteran, Insomnia, Primary Healthcare
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.

Brief Behavioral Treatment for InsomniaBehavioural
Participants will receive 4 weeks of Brief Behavioral Treatment for Insomnia (BBTI). BBTI consists of two in-person sessions, with the two other sessions conducted via telephone. BBTI emphasizes behavioral elements of insomnia treatment. Treatment begins with sleep education and discussion of the biological rhythms that influence sleep cycles. Next, a series of interventions are employed that are derived from sleep restriction and stimulus control techniques.
Progressive Muscle RelaxationBehavioural
Participants will receive 4 weeks of progressive muscle relaxation training (PMRT). PMRT consists of two in-person and two phone sessions. Treatment begins with training on muscle tensing and relaxing, and advances to progressively more efficient tensing-relaxing and passive relaxation exercises. Sessions are employed that teach techniques and problem-solve barriers to the use of PMRT.

Study groups in NCT02571452
Study group	Role	What they receive
Brief Behavioral Treatment for Insomnia	Experimental	Participants will receive 4 weeks of Brief Behavioral Treatment for Insomnia (BBTI). BBTI consists of two in-person sessions, with the two other sessions conducted via telephone. BBTI emphasizes behavioral elements of insomnia treatment. Treatment begins with sleep education and discussion of the biological rhythms that influence sleep cycles. Next, a series of interventions are employed that are derived from sleep restriction and stimulus control techniques. Receives: Behavioral: Brief Behavioral Treatment for Insomnia
Progressive Muscle Relaxation	Active comparator	Participants will receive 4 weeks of progressive muscle relaxation training (PMRT). PMRT consists of two in-person and two phone sessions. Treatment begins with training on muscle tensing and relaxing, and advances to progressively more efficient tensing-relaxing and passive relaxation exercises. Sessions are employed that teach techniques and problem-solve barriers to the use of PMRT. Receives: Behavioral: Progressive Muscle Relaxation

What is being measured

The primary outcome is the main question the study is designed to answer.

Work and Social Adjustment Scale (WSAS)
The WSAS assesses functioning at work, home, management, social leisure activities, private leisure activities, and relationships with others. Scores range from 0-40, with higher scores meaning greater impairment. The measure was administered at Baseline (week 0), Mid-treatment (week 3) \& Post-treatment (week 5).
Measured: Change from Mid-treatment to Post-treatment (week 3 to week 5), with Baseline as a covariate
Work and Social Adjustment Scale (WSAS)
The WSAS assesses functioning at work, home, management, social leisure activities, private leisure activities, and relationships with others. Scores range from 0-40, with higher scores meaning greater impairment. The WSAS was administered at Follow-up (6 months Post-treatment) for participants receiving the experimental treatment only.
Measured: Change from Post-treatment to Follow-up (after 6 months)--for treatment arm only

Secondary outcomes (2)

Insomnia Severity (ISI)
The ISI is a specific index of perceived insomnia severity. Areas assessed include problems with sleep onset, sleep maintenance, and early morning awakening; dissatisfaction with sleep; interference with daily functioning; impact on quality of life; and worry about sleep problems. Scores range from 0-28, with higher scores meaning greater impairment. The measure was administered at Baseline (week 0), Mid-treatment (week 3) \& Post-treatment (week 5).
Measured: Change from Mid-treatment to Post-treatment (week 3 to week 5), with Baseline as a covariate
Insomnia Severity (ISI)
Insomnia Severity Index (ISI) is a specific index of perceived insomnia severity. Areas assessed include problems with sleep onset, sleep maintenance, and early morning awakening; dissatisfaction with sleep; interference with daily functioning; impact on quality of life; and worry about sleep problems. Scores range from 0-28, with higher scores meaning greater impairment. The ISI was administered at Follow-up (6 months Post-treatment) for participants receiving the experimental treatment only.
Measured: Change from Post-treatment to Follow-up (after 6 months)--for treatment arm only

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jan 201630 Jun 2019

First posted8 Oct 2015 (estimated)
Study start6 Jan 2016
Primary completion31 Mar 2019
Study completion30 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Insomnia DisorderStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe 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: Single blind
Who is masked: Outcomes assessor
Enrolment: 93 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02571452
Sponsor's protocol ID: D1539-I
Acronym: BBTI
Status last verified: Jan 2020
First submitted: 2 Oct 2015
Last updated: 7 Feb 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Ranney RM, Gloria R, Metzler TJ, Huggins J, Neylan TC, Maguen S. Brief behavioral treatment for insomnia decreases trauma-related nightmare frequency in veterans. J Clin Sleep Med. 2022 Jul 1;18(7):1831-1839. doi: 10.5664/jcsm.10002.
PubMed 35393934
Maguen S, Gloria R, Huggins J, Goldstein LA, Kanady JC, Straus LD, Metzler TJ, Lujan C, Neylan TC. Brief behavioral treatment for insomnia improves psychosocial functioning in veterans: results from a randomized controlled trial. Sleep. 2021 Mar 12;44(3):zsaa205. doi: 10.1093/sleep/zsaa205.
PubMed 33022048

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Telephone-Facilitated Insomnia Treatment in Primary Care for OEF/OIF/OND Veterans
ClinicalTrials.gov ID: NCT02571452
Acronym / sponsor ID: BBTI / D1539-I
Conditions: Insomnia Disorder
Keywords: Veteran, Insomnia, Primary Healthcare
Study type: Interventional
Recruitment status: Completed
Enrolment: 93 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Collaborators: University of California, San Francisco
Study start: 6 Jan 2016 (actual)
Primary completion: 31 Mar 2019 (actual)
Study completion: 30 Jun 2019 (actual)
First posted: 8 Oct 2015 (estimated)
Results: Posted 22 Jan 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Brief Behavioral Treatment for Insomnia	Experimental	Behavioral: Brief Behavioral Treatment for InsomniaParticipants will receive 4 weeks of Brief Behavioral Treatment for Insomnia (BBTI). BBTI consists of two in-person sessions, with the two other sessions conducted via telephone. BBTI emphasizes behavioral elements of insomnia treatment. Treatment begins with sleep education and discussion of the biological rhythms that influence sleep cycles. Next, a series of interventions are employed that are derived from sleep restriction and stimulus control techniques.
Progressive Muscle Relaxation	Active comparator	Behavioral: Progressive Muscle RelaxationParticipants will receive 4 weeks of progressive muscle relaxation training (PMRT). PMRT consists of two in-person and two phone sessions. Treatment begins with training on muscle tensing and relaxing, and advances to progressively more efficient tensing-relaxing and passive relaxation exercises. Sessions are employed that teach techniques and problem-solve barriers to the use of PMRT.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Veterans between the ages of 18-75 years.
Meet DSM-5 Criteria for Insomnia Disorder.
Able attend in-person appointments at the San Francisco VA Medical Center
The investigators will not exclude individuals who are taking insomnia or antidepressant medications, provided they have been stable on these medications for at least one month and still meet criteria for Insomnia Disorder as described above.
The investigators will not exclude Veterans receiving any type of psychotherapy, provided they have received this treatment for at least three months and do not plan to discontinue this treatment during the BBTI trial.

Key exclusion criteria (6 listed)

Conditions that may be associated with comorbid insomnia, including a lifetime history of any psychiatric disorder with psychotic features or bipolar disorder, and alcohol or drug dependence within the past year.
Individuals who meet criteria for alcohol or drug abuse will be asked to reduce alcohol to recommended limits during the course of the study and/or refrain from drug use in order to be included.
Veterans with suicidal or homicidal ideation.
Veterans who are pregnant, due to the biological impact of pregnancy on sleep.
Veterans who work night or rotating shifts.

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
Brief Behavioral Treatment for InsomniaParticipants will receive 4 weeks of Brief Behavioral Treatment for Insomnia (BBTI). BBTI consists of two in-person sessions, with the two other sessions conducted via telephone. BBTI emphasizes behavioral elements of insomnia treatment. Treatment begins with sleep education and discussion of the biological rhythms that influence sleep cycles. Next, a series of interventions are employed that are derived from sleep restriction and stimulus control techniques.	Behavioural	Brief Behavioral Treatment for Insomnia
Progressive Muscle RelaxationParticipants will receive 4 weeks of progressive muscle relaxation training (PMRT). PMRT consists of two in-person and two phone sessions. Treatment begins with training on muscle tensing and relaxing, and advances to progressively more efficient tensing-relaxing and passive relaxation exercises. Sessions are employed that teach techniques and problem-solve barriers to the use of PMRT.	Behavioural	Progressive Muscle Relaxation

Primary outcome

Work and Social Adjustment Scale (WSAS)
Time frame: Change from Mid-treatment to Post-treatment (week 3 to week 5), with Baseline as a covariate
The WSAS assesses functioning at work, home, management, social leisure activities, private leisure activities, and relationships with others. Scores range from 0-40, with higher scores meaning greater impairment. The measure was administered at Baseline (week 0), Mid-treatment (week 3) \& Post-treatment (week 5).
Work and Social Adjustment Scale (WSAS)
Time frame: Change from Post-treatment to Follow-up (after 6 months)--for treatment arm only
The WSAS assesses functioning at work, home, management, social leisure activities, private leisure activities, and relationships with others. Scores range from 0-40, with higher scores meaning greater impairment. The WSAS was administered at Follow-up (6 months Post-treatment) for participants receiving the experimental treatment only.

2 secondary outcomes

Insomnia Severity (ISI)
Time frame: Change from Mid-treatment to Post-treatment (week 3 to week 5), with Baseline as a covariate
Insomnia Severity (ISI)
Time frame: Change from Post-treatment to Follow-up (after 6 months)--for treatment arm only

Results and safety

Results posted to the registry on 22 Jan 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Brief Behavioral Treatment for Insomnia	47	47
Progressive Muscle Relaxation Training	46	45

Primary outcome: Work and Social Adjustment Scale (WSAS)

Time frame: Change from Mid-treatment to Post-treatment (week 3 to week 5), with Baseline as a covariate. Mean (Standard Deviation). Unit: score on a scale

Measure	Brief Behavioral Treatment for Insomnia n = 46	Progressive Muscle Relaxation n = 45
Baseline	20.1 (9.6)	19.7 (8.9)
Mid-Treatment	14.1 (9.1)	15.8 (9.5)
Post-Treatment	10.8 (9.3)	14.1 (10.0)

Brief Behavioral Treatment for Insomnia vs Progressive Muscle Relaxation: Mean Difference (Net): -3.60 (95% CI -6.65 to -0.55), p = .021, Mixed Models Analysis

Population analysed: An intent-to-treat analysis was conducted on all participants that started treatment (91), not including the two pilot participants.

Primary outcome: Work and Social Adjustment Scale (WSAS)

Time frame: Change from Post-treatment to Follow-up (after 6 months)--for treatment arm only. Mean (Standard Deviation). Unit: score on a scale

Measure	Brief Behavioral Treatment for Insomnia n = 46	Progressive Muscle Relaxation n = 0
Post-Treatment	10.8 (9.3)	–
6-month follow-up	11.2 (10.3)	–

Brief Behavioral Treatment for Insomnia: Mean Difference (Net): 0.52 (95% CI -1.26 to 2.30), p = .568, Mixed Models Analysis

Population analysed: An intent-to-treat analysis was conducted on the 46 participants that completed BBTI treatment. Participants in the PMRT group did not complete the 6-month follow-up assessment and were not included in the analysis.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected beginning from participant screening to the last study visit. For the PMRT group, this was from screening to Post-treatment visits (approximately 7 weeks).For the BBTI group, this was from screening to Follow-up visits (approximately 8 months).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Brief Behavioral Treatment for Insomnia	0 of 47 (0%)	0 of 47 (0%)	0 of 47
Progressive Muscle Relaxation Training	0 of 46 (0%)	0 of 46 (0%)	0 of 46

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35393934Ranney RM, Gloria R, Metzler TJ, Huggins J, Neylan TC, Maguen S. Brief behavioral treatment for insomnia decreases trauma-related nightmare frequency in veterans. J Clin Sleep Med. 2022 Jul 1;18(7):1831-1839. doi: 10.5664/jcsm.10002.
Derived from this study: PubMed 33022048Maguen S, Gloria R, Huggins J, Goldstein LA, Kanady JC, Straus LD, Metzler TJ, Lujan C, Neylan TC. Brief behavioral treatment for insomnia improves psychosocial functioning in veterans: results from a randomized controlled trial. Sleep. 2021 Mar 12;44(3):zsaa205. doi: 10.1093/sleep/zsaa205.
Individual participant dataSharing planned: No

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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.

Shira Maguen, PhD principal investigator

San Francisco VA Medical Center, San Francisco, CA

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Brief Behavioral Treatment for Insomnia and Progressive Muscle Relaxation in people with Insomnia Disorder, run by VA Office of Research and Development 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 10 inclusion and 6 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 7 Feb 2020. 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?

Yes. Results are posted in the registry (first posted 22 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Work and Social Adjustment Scale (WSAS) (time frame: Change from Mid-treatment to Post-treatment (week 3 to week 5), with Baseline as a covariate). The study lists 2 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 NCT02571452, which also lists 2 linked publications.

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 7 Feb 2020.