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Relaxation Treatment for Anxiety in Adults Aged 60 or Older (BREATHE)

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. Read our disclaimer for details. Identifier: NCT02429778
Recruitment Status : Completed
First Posted : April 29, 2015
Results First Posted : January 27, 2020
Last Update Posted : January 27, 2020
VA Palo Alto Health Care System
Brain & Behavior Research Foundation
Information provided by (Responsible Party):
Christine Gould, Stanford University

Brief Summary:
The PI developed a self-directed program to treat late-life anxiety called Breathing, Relaxation, and Education for Anxiety Treatment in the Home Environment (BREATHE). This program consists of weekly video lessons that participants watch on digital video disc (DVD) along with weekly telephone check-ins. In BREATHE participants will learn two behavioral interventions: diaphragmatic breathing and progressive muscle relaxation (PMR). The purpose of the study is to examine whether the self-directed BREATHE program is superior to a wait list control in reducing anxiety in older adults with anxiety disorders. For those assigned to wait list control, they will be offered opportunity to participate in BREATHE treatment after 8 weeks of wait list.

Condition or disease Intervention/treatment Phase
Anxiety Disorders Behavioral: Diaphragmatic Breathing Behavioral: Progressive Muscle Relaxation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Behavioral Intervention (relaxation, breathing, activity engagement)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reducing Late-Life Anxiety and Improving Functioning With Self-Directed Relaxation
Actual Study Start Date : May 2015
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: BREATHE
4 weeks DVD-delivered relaxation intervention program called breathe. The experimental intervention includes progressive muscle relaxation, diaphragmatic breathing, and home practice of the skills. Following the 4 weeks of treatment, participants will be asked to continue to practice at home for 4 weeks.
Behavioral: Diaphragmatic Breathing
Deep or diaphragmatic breathing is taught prior to relaxation.
Other Name: Deep breathing

Behavioral: Progressive Muscle Relaxation
Tensing and releasing muscle groups in a specified order to help reduce tension and anxiety.
Other Name: Progressive Relaxation Training

No Intervention: Wait List
8 week wait list period. Participants assigned to wait list will have the opportunity to receive BREATHE arm after 8 weeks if interested.

Primary Outcome Measures :
  1. Change in Anxiety Symptoms [ Time Frame: Change from baseline to 8 weeks ]
    The Geriatric Anxiety Scale (GAS) 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. Total scores range from 0 to 75 with higher scores indicating worse anxiety. Participants provide severity ratings for items using on a four-point Likert-type scale.

  2. Change in Activity Engagement [ Time Frame: Change from baseline to 8 weeks ]
    The Activity Card Sort 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. The score reported is the lifestyle-adjusted function score. It represents the percentage of activities ever completed that are perceived to be easy. Higher scores indicate greater ease of activity completion/engagement.

Secondary Outcome Measures :
  1. Change in Depressive Symptoms [ Time Frame: Change from baseline to 8 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. It includes one item that inquires about suicide ideation. Higher scores indicate more severe depressive symptoms. Validity and reliability have been established with primary care patients.

  2. Change in Somatic Symptoms [ Time Frame: Change from baseline to 8 weeks ]
    Somatic Symptom Scale (SSS-8). The SSS-8 is an 8-item somatic symptom assessment rated on a five-point Likert-type scale with scores ranging from 0 to 32. The SSS-8 is administered to characterize participants' somatic symptoms. Higher symptoms indicate worse somatic symptom severity.

Other Outcome Measures:
  1. Change in Heart Rate [ Time Frame: Change from baseline to 8 weeks ]
    Heart rate will be measured at baseline and at 8 weeks after enrollment. This is an exploratory measure.

  2. Change in Blood Pressure [ Time Frame: Change from baseline to 8 weeks ]
    Blood pressure will be measured at baseline and at 8 weeks after enrollment. This is an exploratory measure.

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Participants have a diagnosis of an anxiety disorder, specifically, Generalized Anxiety Disorder, Panic Disorder, Agoraphobia, Social Anxiety Disorder or Anxiety Disorder Unspecified/Other Specified).
  • Participants speak English.

Exclusion Criteria:

  • Diagnosis of Dementia
  • Probable presence of significant cognitive impairment according to a brief cognitive screen
  • Serious mental illness (schizophrenia, psychosis, bipolar disorder)

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 identifier (NCT number): NCT02429778

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United States, California
VA Palo Alto Health Care System
Palo Alto, California, United States, 94089
Sponsors and Collaborators
Palo Alto Veterans Institute for Research
VA Palo Alto Health Care System
Brain & Behavior Research Foundation
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Principal Investigator: Christine E Gould, PhD VA Palo Alto/Stanford University
  Study Documents (Full-Text)

Documents provided by Christine Gould, Stanford University:
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Responsible Party: Christine Gould, Instructor (affiliated), Stanford University Identifier: NCT02429778    
Other Study ID Numbers: GOU0001APR
22277 ( Other Grant/Funding Number: Brain and Behavior Research Foundation )
First Posted: April 29, 2015    Key Record Dates
Results First Posted: January 27, 2020
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Deideintified data will be shared upon reasonable request.
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders