Anxiety in Older Veterans

Study Overview
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Brief Summary
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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 Digital Versatile Disc (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.

Detailed Description
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Anxiety is pervasive, costly, and leads to behavioral avoidance, disability, and poor quality of life. The proposed Career Development Award level-2 (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.

Official Title
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Reducing Anxiety and Improving Functioning in Older Veterans

Conditions
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Anxiety Disorders

Intervention / Treatment
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* Behavioral: Progressive Muscle Relaxation
* Behavioral: Diaphragmatic Breathing
* Other: Psychoeducation (Placebo)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Veterans aged 60 years or older. Meets criteria for an anxiety disorder (Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Agoraphobia, Anxiety Disorder Unspecified, Anxiety Disorder Other Specified). English-speaking. Exclusion Criteria: Diagnosis of dementia or significant cognitive impairment as determined by a brief cognitive screen. Diagnosis of serious mental illness (bipolar disorder, psychosis, schizophrenia), taking benzodiazepines more than once a week per self report.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BREATHE<br>Four weeks of DVD-delivered behavioral intervention. Intervention consists of diaphragmatic breathing and progressive muscle relaxation. | Behavioral: Progressive Muscle Relaxation<br>* 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.<br>* Other names: Progressive Relaxation Training;Behavioral: Diaphragmatic Breathing<br>* 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.<br>* Other names: Deep breathing;|
| Placebo Comparator: Psychoeducation<br>Four weeks of DVD-delivered psychoeducation as an attention placebo control. | Other: Psychoeducation (Placebo)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Anxiety Symptoms | 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. Scores range from 0 to 75; higher scores indicate more severe anxiety. | Change from baseline at 12 weeks | 
| Change in Activity Engagement | The Activity Card Sort (ACS; 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. A lifestyle adjusted performance score was calculated on this measure. Scores show of the total activities ever performed in one's life, what percentage are currently performed (0% to 100%). Lower percentages would suggest that individuals are no longer performing activities that they used to do. | Change from baseline at 12 weeks | 
| Change in Anxiety Symptoms | 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. Scores range from 0 to 75; higher scores indicate more severe anxiety. This outcome will be used to examine the effects of the 4 week BREATHE treatment. | Change from baseline at 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Clinician-rated Anxiety Symptoms | The Hamilton Anxiety Scale (HAM-A), a clinician-administered rating scale, assesses the severity of anxiety using 14-items rated on a five-point scale ranging from 0 to 4. It has adequate internal consistency, high inter-rater reliability, and good-to-adequate concurrent validity. The Structured Interview Guide for Hamilton Anxiety Scale provides descriptive anchors to guide clinician decision making ratings based on both frequency and severity. Scores range from 0 to 56 with higher scores indicative of more severe anxiety. | Change from baseline at 12 weeks | 
| Change in Functioning | The Veterans Research and Development Corporation (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. We used the mental health functioning component of the VR-12. The VR-12 scores are standardized using a T-score metric with a mean of 50 and a standard deviation of 10. Scores range from 0 (worst possible outcome) to 100 (best possible outcome). | Change from baseline at 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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behavioral intervention, relaxation, Veterans, geriatric