ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov Identifier: NCT02429778
Recruitment Status : Completed
First Posted : April 29, 2015
Last Update Posted : April 18, 2018
Sponsor:
Collaborators:
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

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. 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.


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. 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.


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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 ClinicalTrials.gov identifier (NCT number): NCT02429778


Locations
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
Investigators
Principal Investigator: Christine E Gould, PhD VA Palo Alto/Stanford University

Responsible Party: Christine Gould, Instructor (affiliated), Stanford University
ClinicalTrials.gov Identifier: NCT02429778     History of Changes
Other Study ID Numbers: GOU0001APR
22277 ( Other Grant/Funding Number: Brain and Behavior Research Foundation )
First Posted: April 29, 2015    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders