Skip to main content
OpenTrials
Completed

NCT Number: NCT02429778

Relaxation Treatment for Anxiety in Adults Aged 60 or Older

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anxiety Disorders Mental Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Palo Alto Health Care System

Palo Alto, California, 94089, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Diaphragmatic breathing

Behavioral

Deep or diaphragmatic breathing is taught prior to relaxation.

Other names: Deep breathing

Progressive Muscle Relaxation

Behavioral

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

Other names: Progressive Relaxation Training

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Palo Alto Veterans Institute for Research

Other

Collaborators

  • Brain & Behavior Research Foundation
  • VA Palo Alto Health Care System

Registry information

Official study title

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

Acronym: BREATHE

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 29, 2015
Registry last updated
Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.