Anxiety in Older Veterans (BREATHE)

• ClinicalTrials.gov Identifier: NCT02400723
• Recruitment Status: Completed
• First Posted: March 27, 2015
• Results First Posted: January 31, 2023
• Last Update Posted: January 31, 2023
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

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.

Condition or disease	Intervention/treatment	Phase
Anxiety Disorders	Behavioral: Progressive Muscle Relaxation; Behavioral: Diaphragmatic Breathing; Other: Psychoeducation (Placebo)	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Reducing Anxiety and Improving Functioning in Older Veterans
• Actual Study Start Date: December 5, 2018
• Actual Primary Completion Date: March 1, 2021
• Actual Study Completion Date: March 1, 2021

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 Name: Progressive Relaxation Training; 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 Name: Deep breathing
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.

Outcome Measures

Primary Outcome Measures :

1. Change in Anxiety Symptoms [ Time Frame: 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. Scores range from 0 to 75; higher scores indicate more severe anxiety.
2. Change in Activity Engagement [ Time Frame: Change from baseline at 12 weeks ]
   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.
3. Change in Anxiety Symptoms [ Time Frame: 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. 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 :

1. Change in Clinician-rated Anxiety Symptoms [ Time Frame: Change from baseline at 12 weeks ]
   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.
2. Change in Functioning [ Time Frame: Change from baseline at 12 weeks ]
   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).

Other Outcome Measures:

1. Change in Anxiety Control [ Time Frame: 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. 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.
2. Change in Depressive Symptoms [ Time Frame: Change from baseline at 12 weeks ]
   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.
3. Comorbidity [ Time Frame: 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. 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.

Eligibility Criteria

• Ages Eligible for Study: 60 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, California

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)

Documents provided by VA Office of Research and Development:

Study Protocol and Statistical Analysis Plan  [PDF] January 31, 2021

Informed Consent Form  [PDF] January 31, 2021

More Information

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT02400723
• Other Study ID Numbers: D1478-W; 1IK2RX001478-01A2 ( U.S. NIH Grant/Contract )
• First Posted: March 27, 2015
• Results First Posted: January 31, 2023
• Last Update Posted: January 31, 2023
• Last Verified: May 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by VA Office of Research and Development:

behavioral intervention; relaxation; Veterans; geriatric

Additional relevant MeSH terms:

Anxiety Disorders; Mental Disorders