Clinical trial NCT02400723: Anxiety in Older Veterans
Official title: Reducing Anxiety and Improving Functioning in Older Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Keywords: behavioral intervention
relaxation
Veterans
geriatric
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2015-03-27
Enrollment: 56
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Anxiety Symptoms
timeFrame: Change from baseline at 12 weeks
measure: Change in Activity Engagement
timeFrame: Change from baseline at 12 weeks
measure: Change in Anxiety Symptoms
timeFrame: Change from baseline at 4 weeks
Secondary outcomes:
measure: Change in Clinician-rated Anxiety Symptoms
timeFrame: Change from baseline at 12 weeks
measure: Change in Functioning
timeFrame: Change from baseline at 12 weeks
Other outcomes:
measure: Change in Anxiety Control
timeFrame: Change from baseline at 12 weeks
measure: Change in Depressive Symptoms
timeFrame: Change from baseline at 12 weeks
measure: Comorbidity
timeFrame: Baseline
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System, Palo Alto, CA
state: California
Study officials:
affiliation: VA Palo Alto Health Care System, Palo Alto, CA
name: Christine E Gould, PhD
role: PRINCIPAL_INVESTIGATOR
References: