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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief Behavioral Treatment for Insomnia | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | Change from Post-treatment to Follow-up (after 6 months)--for treatment arm only |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
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.
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shira Maguen, PhD | San Francisco VA Medical Center, San Francisco, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco VA Medical Center, San Francisco, CA | San Francisco | California | 94121 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35393934 | Derived | 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. | |
| 33022048 | Derived | 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. |
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A total of 157 people provided consent for screening, 119 completed screening and 93 were eligible, enrolled and randomized to treatment. Of the 93, two were withdrawn during treatment or 6-month follow-up due to no longer meeting eligibility and two were pilot subjects that didn't meet inclusion criteria and weren't included in data analysis.
Participants were recruited from 1/6/16 to 8/9/18 through local advertisements, referrals from other research studies or VA clinicians and direct mailings to veterans that had established care at the San Francisco VA (SFVA) or that lived within a 40-mile radius of the SFVA.
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| ID | Title | Description |
|---|---|---|
| FG000 | Brief Behavioral Treatment for Insomnia | 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. Brief Behavioral Treatment for Insomnia: 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. |
| FG001 | Progressive Muscle Relaxation Training | 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. Progressive Muscle Relaxation: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study Treatment |
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| Overall Study 6-Month Follow-up |
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One participant in each group was a pilot participant that didn't meet all inclusion criteria. Therefore, these two individuals were not included in data analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Brief Behavioral Treatment for Insomnia | 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. Brief Behavioral Treatment for Insomnia: 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | One participant in each group was a pilot participant that didn't meet all inclusion criteria. Therefore, these two individuals were not included in data analysis. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | An intent-to-treat analysis was conducted on all participants that started treatment (91), not including the two pilot participants. | Posted | Mean | Standard Deviation | score on a scale | Change from Mid-treatment to Post-treatment (week 3 to week 5), with Baseline as a covariate |
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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).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Brief Behavioral Treatment for Insomnia | 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. Brief Behavioral Treatment for Insomnia: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shira Maguen | San Francisco VA Healthcare System | 415-221-4810 | 22511 | Shira.Maguen@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 2, 2020 | Jan 2, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D001326 | Autogenic Training |
| ID | Term |
|---|---|
| D006990 | Hypnosis |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Progressive Muscle Relaxation | Behavioral | 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. |
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| 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. | Change from Post-treatment to Follow-up (after 6 months)--for treatment arm only |
| NOT COMPLETED |
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| BG001 | Progressive Muscle Relaxation Training | 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. Progressive Muscle Relaxation: 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. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
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| Sex: Female, Male | One participant in each group was a pilot participant that didn't meet all inclusion criteria. These two individuals were not included in data analysis. Additionally, these categories exclude 1 transgender participant in the PMRT group, so the numbers below only reflects the individuals that identified as male or female. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | One participant in each group was a pilot participant that didn't meet all inclusion criteria. Therefore, these two individuals were not included in data analysis. | Count of Participants | Participants |
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| Race (NIH/OMB) | One participant in each group was a pilot participant that didn't meet all inclusion criteria. Therefore, these two individuals were not included in data analysis. | Count of Participants | Participants |
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| Region of Enrollment | One participant in each group was a pilot participant that didn't meet all inclusion criteria. Therefore, these two individuals were not included in data analysis. | Number | participants |
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| OG001 | Progressive Muscle Relaxation | 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. Progressive Muscle Relaxation: 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. |
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| Primary | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Change from Post-treatment to Follow-up (after 6 months)--for treatment arm only |
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| Secondary | 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). | An intent-to-treat analysis was conducted on all participants that started treatment (91), not including the two pilot participants. | Posted | Mean | Standard Deviation | score on a scale | Change from Mid-treatment to Post-treatment (week 3 to week 5), with Baseline as a covariate |
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| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Change from Post-treatment to Follow-up (after 6 months)--for treatment arm only |
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| 0 |
| 47 |
| 0 |
| 47 |
| 0 |
| 47 |
| EG001 | Progressive Muscle Relaxation Training | 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. Progressive Muscle Relaxation: 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. | 0 | 46 | 0 | 46 | 0 | 46 |
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| D001523 |
| Mental Disorders |
| D011613 |
| Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| 6-month follow-up |
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| Mid-Treatment |
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| Post-Treatment |
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| 6-month follow-up |
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