Relaxation Treatment for Anxiety in Adults Aged 60 or Older

Study Overview
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Brief Summary
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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.

Official Title
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Reducing Late-Life Anxiety and Improving Functioning With Self-Directed Relaxation

Conditions
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Anxiety Disorders

Intervention / Treatment
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* Behavioral: Diaphragmatic Breathing
* Behavioral: Progressive Muscle Relaxation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants have a diagnosis of an anxiety disorder, specifically, Generalized Anxiety Disorder, Panic Disorder, Agoraphobia, Social Anxiety Disorder or Anxiety Disorder Unspecified/Other Specified). Participants speak English. Exclusion Criteria: Diagnosis of Dementia Probable presence of significant cognitive impairment according to a brief cognitive screen Serious mental illness (schizophrenia, psychosis, bipolar disorder)

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
Interventional Model Description: Behavioral Intervention (relaxation, breathing, activity engagement)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BREATHE<br>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. | Behavioral: Diaphragmatic Breathing<br>* Deep or diaphragmatic breathing is taught prior to relaxation.<br>* Other names: Deep breathing;Behavioral: Progressive Muscle Relaxation<br>* Tensing and releasing muscle groups in a specified order to help reduce tension and anxiety.<br>* Other names: Progressive Relaxation Training;|
| No Intervention: Wait List<br>8 week wait list period. Participants assigned to wait list will have the opportunity to receive BREATHE arm after 8 weeks if interested. | |

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) 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |