Relaxation Treatment for Anxiety in Adults Aged 60 or Older

NCT ID: NCT02429778

Last Updated: 2020-01-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Anxiety Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Behavioral Intervention (relaxation, breathing, activity engagement)
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Diaphragmatic Breathing

Intervention Type BEHAVIORAL

Deep or diaphragmatic breathing is taught prior to relaxation.

Progressive Muscle Relaxation

Intervention Type BEHAVIORAL

Tensing and releasing muscle groups in a specified order to help reduce tension and anxiety.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Diaphragmatic Breathing

Deep or diaphragmatic breathing is taught prior to relaxation.

Intervention Type BEHAVIORAL

Progressive Muscle Relaxation

Tensing and releasing muscle groups in a specified order to help reduce tension and anxiety.

Intervention Type BEHAVIORAL

Other Intervention Names

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Deep breathing Progressive Relaxation Training

Eligibility Criteria

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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)
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Palo Alto Health Care System

FED

Sponsor Role collaborator

Brain & Behavior Research Foundation

OTHER

Sponsor Role collaborator

Palo Alto Veterans Institute for Research

OTHER

Sponsor Role lead

Responsible Party

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Christine Gould

Instructor (affiliated)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christine E Gould, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Palo Alto/Stanford University

Locations

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VA Palo Alto Health Care System

Palo Alto, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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22277

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

GOU0001APR

Identifier Type: -

Identifier Source: org_study_id

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