Anxiety in Older Veterans (BREATHE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02400723|
Recruitment Status : Recruiting
First Posted : March 27, 2015
Last Update Posted : May 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Anxiety Disorders||Behavioral: Progressive Muscle Relaxation Behavioral: Diaphragmatic Breathing Other: Psychoeducation (Placebo)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Reducing Anxiety and Improving Functioning in Older Veterans|
|Actual Study Start Date :||December 5, 2018|
|Estimated Primary Completion Date :||June 1, 2020|
|Estimated Study Completion Date :||June 1, 2020|
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.
- 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.
- change in activity engagement [ Time Frame: 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 [ 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. This outcome will be used to examine the effects of the 4 week BREATHE treatment.
- change in clinician-rated anxiety symptoms [ Time Frame: 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 [ Time Frame: 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.
- 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. 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 [ Time Frame: 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 [ 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. This construct of comorbidity is being examined as a potential moderator of treatment outcomes in exploratory analyses.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02400723
|Contact: Christine E Gould, PhD||(650) 493-5000 ext firstname.lastname@example.org|
|Contact: Sherry A Beaudreau, PhD||(650) 493-5000 ext 64119||Sherry.Beaudreau@va.gov|
|United States, California|
|VA Palo Alto Health Care System, Palo Alto, CA||Recruiting|
|Palo Alto, California, United States, 94304-1290|
|Contact: Christine E Gould, PhD 650-493-5000 ext 68899 email@example.com|
|Principal Investigator: Christine E Gould, PhD|
|Principal Investigator:||Christine E Gould, PhD||VA Palo Alto Health Care System, Palo Alto, CA|