Trial Outcomes & Findings for Anxiety in Older Veterans (NCT NCT02400723)

Last Updated: 2023-01-31

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

56 participants

Primary outcome timeframe

Change from baseline at 12 weeks

Results posted on

2023-01-31

Participant Flow

Participant milestones

Participant milestones
Measure	BREATHE Four weeks of video-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.	Psychoeducation Four weeks of video-delivered psychoeducation as an attention placebo control. Psychoeducation (Placebo): video-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.
Overall Study STARTED	27	29
Overall Study COMPLETED	22	24
Overall Study NOT COMPLETED	5	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Anxiety in Older Veterans

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BREATHE n=27 Participants 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.	Psychoeducation n=29 Participants 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.	Total n=56 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants
Age, Categorical >=65 years	24 Participants n=5 Participants	22 Participants n=7 Participants	46 Participants n=5 Participants
Age, Continuous	72.8 years STANDARD_DEVIATION 6.2 • n=5 Participants	70.0 years STANDARD_DEVIATION 6.0 • n=7 Participants	71.4 years STANDARD_DEVIATION 6.2 • n=5 Participants
Sex/Gender, Customized Male	23 Participants n=5 Participants	25 Participants n=7 Participants	48 Participants n=5 Participants
Sex/Gender, Customized Female	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Sex/Gender, Customized Unknown	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=5 Participants	21 Participants n=7 Participants	43 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants	21 Participants n=7 Participants	39 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	27 Participants n=5 Participants	29 Participants n=7 Participants	56 Participants n=5 Participants
Geriatric Anxiety Scale	17.1 units on a scale STANDARD_DEVIATION 10.4 • n=5 Participants	18.8 units on a scale STANDARD_DEVIATION 10.5 • n=7 Participants	18.0 units on a scale STANDARD_DEVIATION 10.4 • n=5 Participants
Patients Health Questionnaire 9-item	7.4 units on a scale STANDARD_DEVIATION 6.1 • n=5 Participants	6.7 units on a scale STANDARD_DEVIATION 4.6 • n=7 Participants	7.0 units on a scale STANDARD_DEVIATION 5.3 • n=5 Participants
Hamilton Anxiety Scale	18.0 units on a scale STANDARD_DEVIATION 7.6 • n=5 Participants	16.6 units on a scale STANDARD_DEVIATION 7.1 • n=7 Participants	17.3 units on a scale STANDARD_DEVIATION 7.3 • n=5 Participants

PRIMARY outcome

Timeframe: Change from baseline at 12 weeks

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

Outcome measures

Outcome measures
Measure	BREATHE n=22 Participants 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.	Psychoeducation n=24 Participants 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.
Change in Anxiety Symptoms	1.77 units on a scale Standard Deviation 9.29	-2.42 units on a scale Standard Deviation 7.88

PRIMARY outcome

Timeframe: 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)

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.

Outcome measures

Outcome measures
Measure	BREATHE n=15 Participants 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.	Psychoeducation n=18 Participants 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.
Change in Activity Engagement	2.74 percentage of activities Standard Deviation 8.71	.71 percentage of activities Standard Deviation 10.42

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	BREATHE n=22 Participants 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.	Psychoeducation n=28 Participants 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.
Change in Anxiety Symptoms	1.45 units on a scale Standard Deviation 6.40	-4.75 units on a scale Standard Deviation 9.72

SECONDARY outcome

Timeframe: Change from baseline at 12 weeks

Population: Eight participants were missing post-assessments.

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.

Outcome measures

Outcome measures
Measure	BREATHE n=22 Participants 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.	Psychoeducation n=24 Participants 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.
Change in Clinician-rated Anxiety Symptoms	-2.36 units on a scale Standard Deviation 6.36	-.042 units on a scale Standard Deviation 7.10

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	BREATHE n=22 Participants 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.	Psychoeducation n=24 Participants 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.
Change in Functioning	-.09 units on a scale Standard Deviation 2.45	-.67 units on a scale Standard Deviation 2.73

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline at 12 weeks

Population: 8 participants were missing post assessments.

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.

Outcome measures

Outcome measures
Measure	BREATHE n=23 Participants 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.	Psychoeducation n=25 Participants 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.
Change in Anxiety Control	6.35 units on a scale Standard Deviation 24.86	5.76 units on a scale Standard Deviation 20.06

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	BREATHE n=22 Participants 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.	Psychoeducation n=24 Participants 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.
Change in Depressive Symptoms	.00 units on a scale Standard Deviation 4.08	-.21 units on a scale Standard Deviation 3.09

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

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

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.

Outcome measures

Outcome measures
Measure	BREATHE n=26 Participants 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.	Psychoeducation n=29 Participants 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.
Comorbidity	1.59 units on a scale Standard Deviation .29	1.57 units on a scale Standard Deviation .30

Adverse Events

BREATHE

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Psychoeducation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	BREATHE n=27 participants at risk 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.	Psychoeducation n=29 participants at risk 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.
Musculoskeletal and connective tissue disorders Abdominal pain, muscle strain	3.7% 1/27 • Number of events 1 • 12 weeks	0.00% 0/29 • 12 weeks

Additional Information

Christine Gould, PhD

VA Palo Alto Health Care System

Phone: 650-493-5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place