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

Reducing Late-Life Anxiety and Improving Functioning With Self-Directed Relaxation

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.

Study Overview

• Status: Completed
• Conditions: Anxiety Disorders
• Intervention / Treatment: Behavioral: Diaphragmatic Breathing; Behavioral: Progressive Muscle Relaxation

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94089
      • VA Palo Alto Health Care System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Deep breathing; Behavioral: Progressive Muscle Relaxation; Tensing and releasing muscle groups in a specified order to help reduce tension and anxiety.; Other Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Anxiety Symptoms	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.	Change from baseline to 8 weeks
Change in Activity Engagement	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.	Change from baseline to 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Depressive Symptoms	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.	Change from baseline to 8 weeks
Change in Somatic Symptoms	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.	Change from baseline to 8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Heart Rate	Heart rate will be measured at baseline and at 8 weeks after enrollment. This is an exploratory measure.	Change from baseline to 8 weeks
Change in Blood Pressure	Blood pressure will be measured at baseline and at 8 weeks after enrollment. This is an exploratory measure.	Change from baseline to 8 weeks

Collaborators and Investigators

• Sponsor: Palo Alto Veterans Institute for Research
• Collaborators: VA Palo Alto Health Care System; Brain & Behavior Research Foundation
• Investigators: Principal Investigator: Christine E Gould, PhD, VA Palo Alto/Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: April 21, 2015
• First Submitted That Met QC Criteria: April 24, 2015
• First Posted (Estimate): April 29, 2015

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 24, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: GOU0001APR; 22277 (Other Identifier: City of Hope Medical Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Deideintified data will be shared upon reasonable request.