BREATHE: Anxiety in Older Veterans
Study Details
Study Description
Brief Summary
Anxiety leads to poor quality of life, avoidance of activities, decreased social engagement, functional decline, and disability in older patients. This study will compare two self-directed treatments delivered via DVD videos that can be viewed in one's own home. The two treatments being compared are: psychoeducation, which refers to information and education about anxiety, and a behavioral treatment program, called BREATHE (Breathing, Relaxation and Education for Anxiety Treatment in the Home Environment). BREATHE teaches diaphragmatic breathing and progressive muscle relaxation. Participants will be randomly assigned to either treatment. The study is 12 weeks long. There are 4 weeks of treatment via DVD and 8 weeks of follow-up. Participants will be asked questions about anxiety symptoms, mood, health and functioning.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
Anxiety is pervasive, costly, and leads to behavioral avoidance, disability, and poor quality of life. The proposed CDA-2 study will examine the efficacy of a brief psychosocial intervention for anxiety in older Veterans with anxiety disorders. The psychosocial intervention is called BREATHE (Breathing, Relaxation and Education for Anxiety Treatment in the Home Environment) and teaches diaphragmatic breathing and progressive muscle relaxation via DVD videos that can be viewed in Veterans' own homes. The BREATHE treatment includes age-appropriate vignettes of anxiety-evoking situations. This project is aligned with older adults' preference of psychotherapy to pharmacotherapy for treating anxiety. BREATHE is expected to benefit older Veterans ( 60 years) by reducing anxiety and avoidance and thereby increasing their engagement in activities and improving overall functioning. This aim will be tested in a randomized control trial of DVD-based BREATHE compared with DVD-based psychoeducation in 60 older Veterans with anxiety disorders (Generalized Anxiety Disorder, Panic Disorder, Agoraphobia, Social Anxiety Disorder, and unspecified/other specified anxiety disorder). The study is 12 weeks long with both treatments lasting 4 weeks followed by an 8 week follow-up period. It is hypothesized that BREATHE will result in a statistically and clinically significant reduction of anxiety symptoms as measured with the Geriatric Anxiety Scale compared with psychoeducation. Improvements in functioning (Activity Card Sort) are expected for participants randomized to the BREATHE condition compared with those randomized to psychoeducation. Hypotheses in will be addressed with mixed effects models.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: BREATHE Four weeks of DVD-delivered behavioral intervention. Intervention consists of diaphragmatic breathing and progressive muscle relaxation. |
Behavioral: Progressive Muscle Relaxation
Progressive Muscle Relaxation is a treatment in which individuals tense and release their muscle groups in a sequential order. This helps reduce anxiety and tension. It also teaches individuals to differentiate between muscle tension and relaxation.
Other Names:
Behavioral: Diaphragmatic Breathing
Diaphragmatic breathing is a way in which people breathe using their diaphragm. This type of breathing has been found to promote relaxation and reduce stress.
Other Names:
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| Placebo Comparator: Psychoeducation Four weeks of DVD-delivered psychoeducation as an attention placebo control. |
Other: Psychoeducation (Placebo)
DVD-delivered psychoeducation. Participants will view videos that contain information about what anxiety is and information about one's well-being. This condition is an attention placebo control.
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Outcome Measures
Primary Outcome Measures
- change in anxiety symptoms [Change from baseline at 12 weeks]
The Geriatric Anxiety Scale (GAS) (Segal et al., 2010) 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. Participants provide severity ratings for items using on a four-point Likert-type scale.
- change in activity engagement [Change from baseline at 12 weeks]
The Activity Card Sort (Baum & Edwards, 2001) 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.
- change in anxiety symptoms [Change from baseline at 4 weeks]
The Geriatric Anxiety Scale (GAS) (Segal et al., 2010) 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. Participants provide severity ratings for items using on a four-point Likert-type scale. This outcome will be used to examine the effects of the 4 week BREATHE treatment.
Secondary Outcome Measures
- change in clinician-rated anxiety symptoms [Change from baseline at 12 weeks]
The Hamilton Anxiety Scale (HAM-A) (Hamilton, 1959), a clinician-administered rating scale, assesses the severity of anxiety using 14-items rated on a five-point scale. It has adequate internal consistency, high inter-rater reliability, and good-to-adequate concurrent validity (Diefenbach et al., 2001; Stanley et al., 2009). The Structured Interview Guide for Hamilton Anxiety Scale (Shear et al., 2001) provides descriptive anchors to guide clinician decision making ratings based on both frequency and severity.
- change in functioning [Change from baseline at 12 weeks]
The Veterans RAND 12-Item Health Survey (VR-12) is a 12-item measure that assesses mental and physical health and functioning. It is validated for use with Veterans. The measure includes subjective ratings of one's health and assessments of functioning for the past four weeks.
Other Outcome Measures
- change in anxiety control [Change from baseline at 12 weeks]
The Anxiety Control Questionnaire (ACQ) (Rapee et al., 1996) is a 30-item self-report measure assessing one's perceived ability to control anxiety-evoking situations and emotional reactions to these situations. This measure assess aspects of avoidance and was included to examine whether BREATHE has an effect on perceived anxiety control compared with the psychoeducation control condition. This questionnaire asks participants to indicate how typical each statement is of themselves.
- change in depressive symptoms [Change from baseline at 12 weeks]
The Patient Health Questionnaire 9-item (PHQ-9)(Kroenke, Spitzer, & Williams, 2001) 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. Validity and reliability have been established with primary care patients (Kroenke et al., 2001).
- Comorbidity [Baseline]
The Cumulative Illness Rating Scale for Geriatrics (CIRS-G) was selected to measure comorbidity. The CIRS-G assesses severity of conditions important to older adults' functional status and well-being, such as arthritis, that are impairing yet not fatal. Raters will examine the severity of 14 medical problem categories. Categories include the severity of present illness and the consideration of past medical history. This construct of comorbidity is being examined as a potential moderator of treatment outcomes in exploratory analyses.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Veterans aged 60 years or older.
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Meets criteria for an anxiety disorder (Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Agoraphobia, Anxiety Disorder Unspecified, Anxiety Disorder Other Specified).
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English-speaking.
Exclusion Criteria:
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Diagnosis of dementia or significant cognitive impairment as determined by a brief cognitive screen.
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Diagnosis of serious mental illness (bipolar disorder, psychosis, schizophrenia),
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taking benzodiazepines more than once a week per self report.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto | California | United States | 94304-1290 |
Sponsors and Collaborators
- VA Office of Research and Development
Investigators
- Principal Investigator: Christine E Gould, PhD, VA Palo Alto Health Care System, Palo Alto, CA
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- D1478-W
- 1IK2RX001478-01A2