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Trial record 6 of 51 for:    psychoeducation | Not yet recruiting Studies

Anxiety in Older Veterans (BREATHE)

This study is not yet open for participant recruitment.
Verified October 2017 by VA Office of Research and Development
Sponsor:
ClinicalTrials.gov Identifier:
NCT02400723
First Posted: March 27, 2015
Last Update Posted: October 23, 2017
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.
Information provided by (Responsible Party):
VA Office of Research and Development
  Purpose
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 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.

Condition Intervention
Anxiety Disorders Behavioral: Progressive Muscle Relaxation Behavioral: Diaphragmatic Breathing Other: Psychoeducation (Placebo)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reducing Anxiety and Improving Functioning in Older Veterans

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Estimated Enrollment: 60
Anticipated Study Start Date: January 1, 2018
Estimated Study Completion Date: December 31, 2019
Estimated Primary Completion Date: December 31, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BREATHE
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.

Detailed Description:
Anxiety is pervasive, costly, and leads to behavioral avoidance, disability, and poor quality of life. The proposed 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

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Christine E Gould, PhD (650) 493-5000 ext 68899 christine.gould@va.gov
Contact: Sherry A Beaudreau, PhD (650) 493-5000 ext 64119 Sherry.Beaudreau@va.gov

Locations
United States, California
VA Palo Alto Health Care System, Palo Alto, CA Not yet recruiting
Palo Alto, California, United States, 94304-1290
Contact: Christine E Gould, PhD    650-493-5000 ext 68899    christine.gould@va.gov   
Principal Investigator: Christine E Gould, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Christine E Gould, PhD VA Palo Alto Health Care System, Palo Alto, CA
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02400723     History of Changes
Other Study ID Numbers: D1478-W
1IK2RX001478-01A2 ( U.S. NIH Grant/Contract )
First Submitted: February 26, 2015
First Posted: March 27, 2015
Last Update Posted: October 23, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
behavioral intervention
relaxation
Veterans
geriatric

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders