Relaxation Treatment for Anxiety in Adults Aged 60 or Older

Anxiety Disorders Clinical Trial

— BREATHE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02429778
• Other study ID #: GOU0001APR
• Secondary ID: 22277
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: June 2017

Study information

• Verified date: January 2020
• Source: Palo Alto Veterans Institute for Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety Disorders

Intervention

Behavioral:
• Diaphragmatic Breathing
Deep or diaphragmatic breathing is taught prior to relaxation.
• Progressive Muscle Relaxation
Tensing and releasing muscle groups in a specified order to help reduce tension and anxiety.

Locations

Country	Name	City	State
United States	VA Palo Alto Health Care System	Palo Alto	California

Sponsors (3)

Lead Sponsor	Collaborator
Palo Alto Veterans Institute for Research	Brain & Behavior Research Foundation, VA Palo Alto Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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
Primary	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	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
Secondary	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