N/A
N=56
Anxiety in Older Veterans
Anxiety Disorders
Bottom Line
View on ClinicalTrials.gov: NCT02400723 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcome: Primary: Change in Anxiety Symptoms — 1.77; -2.42 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Progressive Muscle Relaxation (Behavioral); Diaphragmatic Breathing (Behavioral); Psychoeducation (Placebo) (Other)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Anxiety Symptoms |
1.45; -4.75 | — |
| PRIMARY Change in Activity Engagement |
2.74; .71 | — |
| PRIMARY Change in Anxiety Symptoms |
1.45; -4.75 | — |
| SECONDARY Change in Clinician-rated Anxiety Symptoms |
-2.36; -.042 | — |
| SECONDARY Change in Functioning |
-.09; -.67 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02400723). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.