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Anxiety in Older Veterans

Reducing Anxiety and Improving Functioning in Older Veterans

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02400723
Acronym
BREATHE
Enrollment
56
Registered
2015-03-27
Start date
2018-12-05
Completion date
2021-03-01
Last updated
2023-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Disorders

Keywords

behavioral intervention, relaxation, Veterans, geriatric

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.

Interventions

OTHERPsychoeducation (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.

BEHAVIORALProgressive 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.

BEHAVIORALDiaphragmatic 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.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Anxiety SymptomsChange from baseline at 12 weeksThe 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 EngagementChange from baseline at 12 weeksThe 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.

Secondary

MeasureTime frameDescription
Change in Clinician-rated Anxiety SymptomsChange from baseline at 12 weeksThe 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 FunctioningChange from baseline at 12 weeksThe 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

MeasureTime frameDescription
Change in Depressive SymptomsChange from baseline at 12 weeksThe 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.
ComorbidityBaselineThe 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.
Change in Anxiety ControlChange from baseline at 12 weeksThe 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
BREATHE
Four weeks of DVD-delivered behavioral intervention. Intervention consists of diaphragmatic breathing and progressive muscle relaxation. 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. 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.
27
Psychoeducation
Four weeks of DVD-delivered psychoeducation as an attention placebo control. 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.
29
Total56

Baseline characteristics

CharacteristicTotalPsychoeducationBREATHE
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
46 Participants22 Participants24 Participants
Age, Categorical
Between 18 and 65 years
10 Participants7 Participants3 Participants
Age, Continuous71.4 years
STANDARD_DEVIATION 6.2
70.0 years
STANDARD_DEVIATION 6
72.8 years
STANDARD_DEVIATION 6.2
Ethnicity (NIH/OMB)
Hispanic or Latino
9 Participants4 Participants5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
43 Participants21 Participants22 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
4 Participants4 Participants0 Participants
Geriatric Anxiety Scale18.0 units on a scale
STANDARD_DEVIATION 10.4
18.8 units on a scale
STANDARD_DEVIATION 10.5
17.1 units on a scale
STANDARD_DEVIATION 10.4
Hamilton Anxiety Scale17.3 units on a scale
STANDARD_DEVIATION 7.3
16.6 units on a scale
STANDARD_DEVIATION 7.1
18.0 units on a scale
STANDARD_DEVIATION 7.6
Patients Health Questionnaire 9-item7.0 units on a scale
STANDARD_DEVIATION 5.3
6.7 units on a scale
STANDARD_DEVIATION 4.6
7.4 units on a scale
STANDARD_DEVIATION 6.1
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
2 Participants2 Participants0 Participants
Race (NIH/OMB)
Black or African American
6 Participants2 Participants4 Participants
Race (NIH/OMB)
More than one race
6 Participants4 Participants2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants0 Participants3 Participants
Race (NIH/OMB)
White
39 Participants21 Participants18 Participants
Region of Enrollment
United States
56 Participants29 Participants27 Participants
Sex/Gender, Customized
Female
7 Participants4 Participants3 Participants
Sex/Gender, Customized
Male
48 Participants25 Participants23 Participants
Sex/Gender, Customized
Unknown
1 Participants0 Participants1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 270 / 29
other
Total, other adverse events
1 / 270 / 29
serious
Total, serious adverse events
0 / 270 / 29

Outcome results

Primary

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.

Time frame: Change from baseline at 12 weeks

Population: Following the onset of the coronavirus pandemic, the research team switched to virtual administration of pre and post measurements with institutional review board approval. This measure was unable to be obtained during these virtual assessments as it required a card sorting procedure that could not be completed by telephone (n = 15 assessments missing due to COVID, n = 1 did not complete measure at baseline; n = 7 missing post assessments including this measure)

ArmMeasureValue (MEAN)Dispersion
BREATHEChange in Activity Engagement2.74 percentage of activitiesStandard Deviation 8.71
PsychoeducationChange in Activity Engagement.71 percentage of activitiesStandard Deviation 10.42
Primary

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.

Time frame: Change from baseline at 12 weeks

Population: Discrepancy is due to some participants missing post-assessments.

ArmMeasureValue (MEAN)Dispersion
BREATHEChange in Anxiety Symptoms1.77 units on a scaleStandard Deviation 9.29
PsychoeducationChange in Anxiety Symptoms-2.42 units on a scaleStandard Deviation 7.88
Primary

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.

Time frame: Change from baseline at 4 weeks

Population: Five participants in the BREATHE group were missing week 4 assessments; 1 participant in Psychoeducation was missing a week 4 assessment.

ArmMeasureValue (MEAN)Dispersion
BREATHEChange in Anxiety Symptoms1.45 units on a scaleStandard Deviation 6.4
PsychoeducationChange in Anxiety Symptoms-4.75 units on a scaleStandard Deviation 9.72
Secondary

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.

Time frame: Change from baseline at 12 weeks

Population: Eight participants were missing post-assessments.

ArmMeasureValue (MEAN)Dispersion
BREATHEChange in Clinician-rated Anxiety Symptoms-2.36 units on a scaleStandard Deviation 6.36
PsychoeducationChange in Clinician-rated Anxiety Symptoms-.042 units on a scaleStandard Deviation 7.1
Secondary

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).

Time frame: Change from baseline at 12 weeks

ArmMeasureValue (MEAN)Dispersion
BREATHEChange in Functioning-.09 units on a scaleStandard Deviation 2.45
PsychoeducationChange in Functioning-.67 units on a scaleStandard Deviation 2.73
Other Pre-specified

Change in Anxiety Control

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

Population: 8 participants were missing post assessments.

ArmMeasureValue (MEAN)Dispersion
BREATHEChange in Anxiety Control6.35 units on a scaleStandard Deviation 24.86
PsychoeducationChange in Anxiety Control5.76 units on a scaleStandard Deviation 20.06
Other Pre-specified

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. 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

ArmMeasureValue (MEAN)Dispersion
BREATHEChange in Depressive Symptoms.00 units on a scaleStandard Deviation 4.08
PsychoeducationChange in Depressive Symptoms-.21 units on a scaleStandard Deviation 3.09
Other Pre-specified

Comorbidity

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

Population: 55 of 56 participants gave permission to review their medical records to derive this rating.

ArmMeasureValue (MEAN)Dispersion
BREATHEComorbidity1.59 units on a scaleStandard Deviation 0.29
PsychoeducationComorbidity1.57 units on a scaleStandard Deviation 0.3

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026