Relaxation Treatment for Anxiety in Adults Aged 60 or Older

NCT02429778 | Completed Results

• 2 other identifiers: GOU0001APR22277
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorders

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in Depressive Symptoms

  Change from baseline to 8 weeks

• Change in Somatic Symptoms

  Change from baseline to 8 weeks

Other Outcomes (2)

• Change in Heart Rate

  Change from baseline to 8 weeks

• Change in Blood Pressure

  Change from baseline to 8 weeks

Study Arms (2)

BREATHE

EXPERIMENTAL

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; Behavioral: Progressive Muscle Relaxation

Wait List

NO INTERVENTION

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

Interventions

Diaphragmatic Breathing BEHAVIORAL

Deep or diaphragmatic breathing is taught prior to relaxation.

Also known as: Deep breathing

BREATHE

Progressive Muscle Relaxation BEHAVIORAL

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

Also known as: Progressive Relaxation Training

BREATHE

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Diagnosis of Dementia
• Probable presence of significant cognitive impairment according to a brief cognitive screen
• Serious mental illness (schizophrenia, psychosis, bipolar disorder)

Sponsors & Collaborators

• Palo Alto Veterans Institute for Research: lead
• VA Palo Alto Health Care System: collaborator
• Brain & Behavior Research Foundation: collaborator

Study Sites (1)

VA Palo Alto Health Care System

Palo Alto, California, 94089, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Hypnosis; Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Christine Gould, PhD
• Organization: VA Palo Alto Health Care System

Christine.Gould@va.gov

650-493-5000

Study Officials

• Christine E Gould, PhD

  VA Palo Alto/Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor (affiliated)

Model Details: Behavioral Intervention (relaxation, breathing, activity engagement)

Study Record Dates

• First Submitted: April 21, 2015
• First Posted: April 29, 2015
• Study Start: May 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: January 27, 2020
• Results First Posted: January 27, 2020

Record last verified: 2020-01

Locations

US (1)