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

Primary Purpose

Anxiety Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diaphragmatic Breathing
Progressive Muscle Relaxation
Sponsored by
Palo Alto Veterans Institute for Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • VA Palo Alto Health Care System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

BREATHE

Wait List

Arm Description

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.

8 week wait list period. Participants assigned to wait list will have the opportunity to receive BREATHE arm after 8 weeks if interested.

Outcomes

Primary Outcome Measures

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 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.

Secondary Outcome Measures

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 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.

Full Information

First Posted
April 21, 2015
Last Updated
January 24, 2020
Sponsor
Palo Alto Veterans Institute for Research
Collaborators
VA Palo Alto Health Care System, Brain & Behavior Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02429778
Brief Title
Relaxation Treatment for Anxiety in Adults Aged 60 or Older
Acronym
BREATHE
Official Title
Reducing Late-Life Anxiety and Improving Functioning With Self-Directed Relaxation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Palo Alto Veterans Institute for Research
Collaborators
VA Palo Alto Health Care System, Brain & Behavior Research Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Behavioral Intervention (relaxation, breathing, activity engagement)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BREATHE
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait List
Arm Type
No Intervention
Arm Description
8 week wait list period. Participants assigned to wait list will have the opportunity to receive BREATHE arm after 8 weeks if interested.
Intervention Type
Behavioral
Intervention Name(s)
Diaphragmatic Breathing
Other Intervention Name(s)
Deep breathing
Intervention Description
Deep or diaphragmatic breathing is taught prior to relaxation.
Intervention Type
Behavioral
Intervention Name(s)
Progressive Muscle Relaxation
Other Intervention Name(s)
Progressive Relaxation Training
Intervention Description
Tensing and releasing muscle groups in a specified order to help reduce tension and anxiety.
Primary Outcome Measure Information:
Title
Change in Anxiety Symptoms
Description
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.
Time Frame
Change from baseline to 8 weeks
Title
Change in Activity Engagement
Description
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.
Time Frame
Change from baseline to 8 weeks
Secondary Outcome Measure Information:
Title
Change in Depressive Symptoms
Description
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.
Time Frame
Change from baseline to 8 weeks
Title
Change in Somatic Symptoms
Description
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.
Time Frame
Change from baseline to 8 weeks
Other Pre-specified Outcome Measures:
Title
Change in Heart Rate
Description
Heart rate will be measured at baseline and at 8 weeks after enrollment. This is an exploratory measure.
Time Frame
Change from baseline to 8 weeks
Title
Change in Blood Pressure
Description
Blood pressure will be measured at baseline and at 8 weeks after enrollment. This is an exploratory measure.
Time Frame
Change from baseline to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine E Gould, PhD
Organizational Affiliation
VA Palo Alto/Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Palo Alto Health Care System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94089
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Deideintified data will be shared upon reasonable request.

Learn more about this trial

Relaxation Treatment for Anxiety in Adults Aged 60 or Older

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