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Anxiety in Older Veterans (BREATHE)

Primary Purpose

Anxiety Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Progressive Muscle Relaxation
Diaphragmatic Breathing
Psychoeducation (Placebo)
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring behavioral intervention, relaxation, Veterans, geriatric

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • VA Palo Alto Health Care System, Palo Alto, CA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BREATHE

Psychoeducation

Arm Description

Four weeks of DVD-delivered behavioral intervention. Intervention consists of diaphragmatic breathing and progressive muscle relaxation.

Four weeks of DVD-delivered psychoeducation as an attention placebo control.

Outcomes

Primary Outcome Measures

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 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 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.

Secondary Outcome Measures

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 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).

Full Information

First Posted
February 26, 2015
Last Updated
May 6, 2022
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT02400723
Brief Title
Anxiety in Older Veterans
Acronym
BREATHE
Official Title
Reducing Anxiety and Improving Functioning in Older Veterans
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
December 5, 2018 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
March 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders
Keywords
behavioral intervention, relaxation, Veterans, geriatric

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BREATHE
Arm Type
Experimental
Arm Description
Four weeks of DVD-delivered behavioral intervention. Intervention consists of diaphragmatic breathing and progressive muscle relaxation.
Arm Title
Psychoeducation
Arm Type
Placebo Comparator
Arm Description
Four weeks of DVD-delivered psychoeducation as an attention placebo control.
Intervention Type
Behavioral
Intervention Name(s)
Progressive Muscle Relaxation
Other Intervention Name(s)
Progressive Relaxation Training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Diaphragmatic Breathing
Other Intervention Name(s)
Deep breathing
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Psychoeducation (Placebo)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Anxiety Symptoms
Description
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.
Time Frame
Change from baseline at 12 weeks
Title
Change in Activity Engagement
Description
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.
Time Frame
Change from baseline at 12 weeks
Title
Change in Anxiety Symptoms
Description
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.
Time Frame
Change from baseline at 4 weeks
Secondary Outcome Measure Information:
Title
Change in Clinician-rated Anxiety Symptoms
Description
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.
Time Frame
Change from baseline at 12 weeks
Title
Change in Functioning
Description
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).
Time Frame
Change from baseline at 12 weeks
Other Pre-specified Outcome Measures:
Title
Change in Anxiety Control
Description
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. Each item is scored using a Likert-type scale with values ranging from 0 (strongly disagree) to 5 (strongly agree). Total scores range from 0 to 150. Higher scores indicate greater perceived control over one's anxiety. 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.
Time Frame
Change from baseline at 12 weeks
Title
Change in Depressive Symptoms
Description
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. Higher scores indicate more severe depression. It includes one item that inquires about suicide ideation. Validity and reliability have been established with primary care patients.
Time Frame
Change from baseline at 12 weeks
Title
Comorbidity
Description
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. Each of 14 categories are rated on a scale from 0 to 4. Total scores range from 0 to 56 with higher scores. The severity scores reported here represent the total score divided by the total number of categories endorsed. Higher scores indicate more severe illness. This construct of comorbidity is being examined as a potential moderator of treatment outcomes in exploratory analyses.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine E Gould, PhD
Organizational Affiliation
VA Palo Alto Health Care System, Palo Alto, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Palo Alto Health Care System, Palo Alto, CA
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304-1290
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Anxiety in Older Veterans

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