An interventional study of Brief Behavioral Treatment for Insomnia and Progressive Muscle Relaxation in Insomnia Disorder, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-02-07.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
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.
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.
This study's enrollment of 93 is above the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
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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.
Exclusion Criteria:
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.
Behavioral: Brief Behavioral Treatment for Insomnia
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.
Behavioral: Progressive Muscle Relaxation
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.
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.
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).
Time frame: 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.
Time frame: Change from Post-treatment to Follow-up (after 6 months)--for treatment arm only
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).
Time frame: 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.
Time frame: Change from Post-treatment to Follow-up (after 6 months)--for treatment arm only
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.
| Milestone | Brief Behavioral Treatment for Insomnia | Progressive Muscle Relaxation Training |
|---|---|---|
| Started | 47 | 46 |
| Completed | 47 | 45 |
| Not completed | 0 | 1 |
| Withdrew: Protocol violation | 0 | 1 |
| Milestone | Brief Behavioral Treatment for Insomnia | Progressive Muscle Relaxation Training |
|---|---|---|
| Started | 47 | 0 |
| Completed | 42 | 0 |
| Not completed | 5 | 0 |
| Withdrew: Lost to follow-up | 4 | 0 |
| Withdrew: Protocol violation | 1 | 0 |
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).
| score on a scale | Brief Behavioral Treatment for Insomnia | Progressive Muscle Relaxation |
|---|---|---|
| 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 |
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.
| score on a scale | Brief Behavioral Treatment for Insomnia | Progressive Muscle Relaxation |
|---|---|---|
| Post-Treatment | 10.8 ± 9.3 | — |
| 6-month follow-up | 11.2 ± 10.3 | — |
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).
| score on a scale | Brief Behavioral Treatment for Insomnia | Progressive Muscle Relaxation |
|---|---|---|
| Baseline | 17.1 ± 3.6 | 17.4 ± 4.0 |
| Mid-Treatment | 10.4 ± 4.6 | 14.2 ± 4.3 |
| Post-Treatment | 8.1 ± 5.4 | 12.4 ± 5.4 |
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.
| score on a scale | Brief Behavioral Treatment for Insomnia | Progressive Muscle Relaxation |
|---|---|---|
| Post-Treatment | 8.1 ± 5.4 | — |
| 6-month follow-up | 7.5 ± 5.7 | — |
Collected over 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).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Brief Behavioral Treatment for Insomnia | 0/47 (0%) | 0/47 (0%) | 0/47 (0%) |
| Progressive Muscle Relaxation Training | 0/46 (0%) | 0/46 (0%) | 0/46 (0%) |
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.
| Age, Continuous(years) | Brief Behavioral Treatment for Insomnia | Progressive Muscle Relaxation Training | Total |
|---|---|---|---|
| Mean | 48.87 ± 15.66 | 49.80 ± 15.46 | 49.32 ± 15.48 |
| Sex: Female, Male(Participants) | Brief Behavioral Treatment for Insomnia | Progressive Muscle Relaxation Training | Total |
|---|---|---|---|
| Female | 9 | 8 | 17 |
| Male | 37 | 36 | 73 |
| Ethnicity (NIH/OMB)(Participants) | Brief Behavioral Treatment for Insomnia | Progressive Muscle Relaxation Training | Total |
|---|---|---|---|
| Hispanic or Latino | 6 | 5 | 11 |
| Not Hispanic or Latino | 39 | 38 | 77 |
| Unknown or Not Reported | 1 | 2 | 3 |
| Race (NIH/OMB)(Participants) | Brief Behavioral Treatment for Insomnia | Progressive Muscle Relaxation Training | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 10 | 7 | 17 |
| Native Hawaiian or Other Pacific Islander | 1 | 2 | 3 |
| Black or African American | 8 | 4 | 12 |
| White | 22 | 24 | 46 |
| More than one race | 3 | 5 | 8 |
| Unknown or Not Reported | 2 | 3 | 5 |
| Region of Enrollment(participants) | Brief Behavioral Treatment for Insomnia | Progressive Muscle Relaxation Training | Total |
|---|---|---|---|
| United States | 46 | 45 | 91 |
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