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| ID | Type | Description | Link |
|---|---|---|---|
| 22277 | Other Grant/Funding Number | Brain and Behavior Research Foundation |
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| Name | Class |
|---|---|
| VA Palo Alto Health Care System | FED |
| Brain & Behavior Research Foundation | OTHER |
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The PI developed a self-directed program to treat late-life anxiety called Breathing, Relaxation, and Education for Anxiety Treatment in the Home Environment (BREATHE). This program consists of weekly video lessons that participants watch on digital video disc (DVD) along with weekly telephone check-ins. In BREATHE participants will learn two behavioral interventions: diaphragmatic breathing and progressive muscle relaxation (PMR). The purpose of the study is to examine whether the self-directed BREATHE program is superior to a wait list control in reducing anxiety in older adults with anxiety disorders. For those assigned to wait list control, they will be offered opportunity to participate in BREATHE treatment after 8 weeks of wait list.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BREATHE | Experimental | 4 weeks DVD-delivered relaxation intervention program called breathe. The experimental intervention includes progressive muscle relaxation, diaphragmatic breathing, and home practice of the skills. Following the 4 weeks of treatment, participants will be asked to continue to practice at home for 4 weeks. |
|
| Wait List | No Intervention | 8 week wait list period. Participants assigned to wait list will have the opportunity to receive BREATHE arm after 8 weeks if interested. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diaphragmatic Breathing | Behavioral | Deep or diaphragmatic breathing is taught prior to relaxation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Anxiety Symptoms | The Geriatric Anxiety Scale (GAS) is a 30-item measure of somatic, cognitive, and affective symptoms of anxiety. The first 25 items of the measure are used to compute the total score; the last 5 items provide information about the content of worries or fears. Total scores range from 0 to 75 with higher scores indicating worse anxiety. Participants provide severity ratings for items using on a four-point Likert-type scale. | Change from baseline to 8 weeks |
| Change in Activity Engagement | The Activity Card Sort contains 80 photographs that depict the performance of instrumental activities, low-physical-demand leisure activities, high-physical-demand leisure activities, and social activities. This measure will be used to assess engagement in activities. The score reported is the lifestyle-adjusted function score. It represents the percentage of activities ever completed that are perceived to be easy. Higher scores indicate greater ease of activity completion/engagement. | Change from baseline to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Depressive Symptoms | The Patient Health Questionnaire 9-item (PHQ-9) is a 9-item depression assessment rated on a four-point Likert-type scale with scores ranging from 0 to 27. It includes one item that inquires about suicide ideation. Higher scores indicate more severe depressive symptoms. Validity and reliability have been established with primary care patients. | Change from baseline to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Heart Rate | Heart rate will be measured at baseline and at 8 weeks after enrollment. This is an exploratory measure. | Change from baseline to 8 weeks |
| Change in Blood Pressure | Blood pressure will be measured at baseline and at 8 weeks after enrollment. This is an exploratory measure. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine E Gould, PhD | VA Palo Alto/Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto Health Care System | Palo Alto | California | 94089 | United States |
Deideintified data will be shared upon reasonable request.
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| ID | Title | Description |
|---|---|---|
| FG000 | BREATHE | 4 weeks DVD-delivered relaxation intervention program called breathe. The experimental intervention includes progressive muscle relaxation, diaphragmatic breathing, and home practice of the skills. Following the 4 weeks of treatment, participants will be asked to continue to practice at home for 4 weeks. Diaphragmatic Breathing: Deep or diaphragmatic breathing is taught prior to relaxation. Progressive Muscle Relaxation: Tensing and releasing muscle groups in a specified order to help reduce tension and anxiety. |
| FG001 | Wait List | 8 week wait list period. Participants assigned to wait list will have the opportunity to receive BREATHE arm after 8 weeks if interested. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BREATHE | 4 weeks DVD-delivered relaxation intervention program called breathe. The experimental intervention includes progressive muscle relaxation, diaphragmatic breathing, and home practice of the skills. Following the 4 weeks of treatment, participants will be asked to continue to practice at home for 4 weeks. Diaphragmatic Breathing: Deep or diaphragmatic breathing is taught prior to relaxation. Progressive Muscle Relaxation: Tensing and releasing muscle groups in a specified order to help reduce tension and anxiety. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Anxiety Symptoms | The Geriatric Anxiety Scale (GAS) is a 30-item measure of somatic, cognitive, and affective symptoms of anxiety. The first 25 items of the measure are used to compute the total score; the last 5 items provide information about the content of worries or fears. Total scores range from 0 to 75 with higher scores indicating worse anxiety. Participants provide severity ratings for items using on a four-point Likert-type scale. | A linear mixed effects model using maximum likelihood modeling was employed to analyze these data using intent-to-treat principles. | Posted | Mean | Standard Error | score on a scale | Change from baseline to 8 weeks |
|
8 weeks
We used the clinicaltrials.gov definition for adverse events reporting. Adverse events were reported via non-systematic assessment. Study assessors and PI were trained to detect any adverse events.
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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 | BREATHE | 4 weeks DVD-delivered relaxation intervention program called breathe. The experimental intervention includes progressive muscle relaxation, diaphragmatic breathing, and home practice of the skills. Following the 4 weeks of treatment, participants will be asked to continue to practice at home for 4 weeks. Diaphragmatic Breathing: Deep or diaphragmatic breathing is taught prior to relaxation. Progressive Muscle Relaxation: Tensing and releasing muscle groups in a specified order to help reduce tension and anxiety. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christine Gould, PhD | VA Palo Alto Health Care System | 650-493-5000 | 68899 | Christine.Gould@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 | Mar 17, 2017 | Jan 14, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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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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Behavioral Intervention (relaxation, breathing, activity engagement)
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| Progressive Muscle Relaxation | Behavioral | Tensing and releasing muscle groups in a specified order to help reduce tension and anxiety. |
|
|
| Change in Somatic Symptoms | Somatic Symptom Scale (SSS-8). The SSS-8 is an 8-item somatic symptom assessment rated on a five-point Likert-type scale with scores ranging from 0 to 32. The SSS-8 is administered to characterize participants' somatic symptoms. Higher symptoms indicate worse somatic symptom severity. | Change from baseline to 8 weeks |
| Change from baseline to 8 weeks |
| BG001 | Wait List | 8 week wait list period. Participants assigned to wait list will have the opportunity to receive BREATHE arm after 8 weeks if interested. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Geriatric Anxiety Scale | The GAS is a 30 item measure of anxiety symptom severity. The total score is based on a sum of the first 25 items. The remaining 5 items are anxiety content items and are not included in the total score. Total scores range from 0 to 75. Higher scores indicate worse anxiety symptom severity. The measure is a self-report assessment completed at baseline, 4 weeks and 8 weeks. | Mean | Standard Deviation | units on a scale |
|
| Somatic Symptom Scale 8-item | The Somatic Symptom Scale is an 8-item self-report completed by participant at baseline and 8 weeks. The total score is a sum of the scores for the 8 items on the measure. Measure ranges in total scores from 0 to 32. Higher scores indicate worse somatic symptom severity. Symptoms include stomach/bowel problems, back pain, headaches, etc. | Mean | Standard Deviation | units on a scale |
|
| Patients Health Questionnaire 9-item | The PHQ-9 is a 9 item measure of depressive symptoms. Scores range from 0 to 27. The total score is a sum of the 9 item responses. Higher scores indicate worse depressive symptoms. This measure is a self-report assessment completed at baseline at 8 weeks. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Wait List | 8 week wait list period. Participants assigned to wait list will have the opportunity to receive BREATHE arm after 8 weeks if interested. |
|
|
| Primary | Change in Activity Engagement | The Activity Card Sort contains 80 photographs that depict the performance of instrumental activities, low-physical-demand leisure activities, high-physical-demand leisure activities, and social activities. This measure will be used to assess engagement in activities. The score reported is the lifestyle-adjusted function score. It represents the percentage of activities ever completed that are perceived to be easy. Higher scores indicate greater ease of activity completion/engagement. | A linear mixed effects model using maximum likelihood modeling was employed to analyze these data using intent-to-treat principles. | Posted | Mean | Standard Error | units on a scale | Change from baseline to 8 weeks |
|
|
|
| Secondary | Change in Depressive Symptoms | The Patient Health Questionnaire 9-item (PHQ-9) is a 9-item depression assessment rated on a four-point Likert-type scale with scores ranging from 0 to 27. It includes one item that inquires about suicide ideation. Higher scores indicate more severe depressive symptoms. Validity and reliability have been established with primary care patients. | A linear mixed effects model using maximum likelihood modeling was employed to analyze these data using intent-to-treat principles. | Posted | Mean | Standard Error | units on a scale | Change from baseline to 8 weeks |
|
|
|
| Secondary | Change in Somatic Symptoms | Somatic Symptom Scale (SSS-8). The SSS-8 is an 8-item somatic symptom assessment rated on a five-point Likert-type scale with scores ranging from 0 to 32. The SSS-8 is administered to characterize participants' somatic symptoms. Higher symptoms indicate worse somatic symptom severity. | A linear mixed effects model using maximum likelihood modeling was employed to analyze these data using intent-to-treat principles. | Posted | Mean | Standard Error | units on a scale | Change from baseline to 8 weeks |
|
|
|
| Other Pre-specified | Change in Heart Rate | Heart rate will be measured at baseline and at 8 weeks after enrollment. This is an exploratory measure. | Not Posted | Change from baseline to 8 weeks | Participants |
| Other Pre-specified | Change in Blood Pressure | Blood pressure will be measured at baseline and at 8 weeks after enrollment. This is an exploratory measure. | Not Posted | Change from baseline to 8 weeks | Participants |
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Wait List | 8 week wait list period. Participants assigned to wait list will have the opportunity to receive BREATHE arm after 8 weeks if interested. | 0 | 20 | 0 | 20 | 0 | 20 |
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| D011613 |
| Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |