NCT02400723

Brief Summary

Anxiety leads to poor quality of life, avoidance of activities, decreased social engagement, functional decline, and disability in older patients. This study will compare two self-directed treatments delivered via Digital Versatile Disc (DVD) videos that can be viewed in one's own home. The two treatments being compared are: psychoeducation, which refers to information and education about anxiety, and a behavioral treatment program, called BREATHE (Breathing, Relaxation and Education for Anxiety Treatment in the Home Environment). BREATHE teaches diaphragmatic breathing and progressive muscle relaxation. Participants will be randomly assigned to either treatment. The study is 12 weeks long. There are 4 weeks of treatment via DVD and 8 weeks of follow-up. Participants will be asked questions about anxiety symptoms, mood, health and functioning.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2015

Completed
29 days until next milestone

First Posted

Study publicly available on registry

March 27, 2015

Completed
3.7 years until next milestone

Study Start

First participant enrolled

December 5, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

January 31, 2023

Completed
Last Updated

January 31, 2023

Status Verified

May 1, 2022

Enrollment Period

2.2 years

First QC Date

February 26, 2015

Results QC Date

February 17, 2022

Last Update Submit

May 6, 2022

Conditions

Anxiety Disorders

Keywords

behavioral interventionrelaxationVeteransgeriatric

Outcome Measures

Primary Outcomes (3)

  • Change in Anxiety Symptoms

    The Geriatric Anxiety Scale (GAS) (Segal et al., 2010) 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. Participants provide severity ratings for items using on a four-point Likert-type scale. Scores range from 0 to 75; higher scores indicate more severe anxiety.

    Change from baseline at 12 weeks

  • Change in Activity Engagement

    The Activity Card Sort (ACS; Baum \& Edwards, 2001) 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. A lifestyle adjusted performance score was calculated on this measure. Scores show of the total activities ever performed in one's life, what percentage are currently performed (0% to 100%). Lower percentages would suggest that individuals are no longer performing activities that they used to do.

    Change from baseline at 12 weeks

  • Change in Anxiety Symptoms

    The Geriatric Anxiety Scale (GAS) (Segal et al., 2010) 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. Participants provide severity ratings for items using on a four-point Likert-type scale. Scores range from 0 to 75; higher scores indicate more severe anxiety. This outcome will be used to examine the effects of the 4 week BREATHE treatment.

    Change from baseline at 4 weeks

Secondary Outcomes (2)

  • Change in Clinician-rated Anxiety Symptoms

    Change from baseline at 12 weeks

  • Change in Functioning

    Change from baseline at 12 weeks

Other Outcomes (3)

  • Change in Anxiety Control

    Change from baseline at 12 weeks

  • Change in Depressive Symptoms

    Change from baseline at 12 weeks

  • Comorbidity

    Baseline

Study Arms (2)

BREATHE

EXPERIMENTAL

Four weeks of DVD-delivered behavioral intervention. Intervention consists of diaphragmatic breathing and progressive muscle relaxation.

Behavioral: Progressive Muscle RelaxationBehavioral: Diaphragmatic Breathing

Psychoeducation

PLACEBO COMPARATOR

Four weeks of DVD-delivered psychoeducation as an attention placebo control.

Other: Psychoeducation (Placebo)

Interventions

Progressive Muscle RelaxationBEHAVIORAL

Progressive Muscle Relaxation is a treatment in which individuals tense and release their muscle groups in a sequential order. This helps reduce anxiety and tension. It also teaches individuals to differentiate between muscle tension and relaxation.

Also known as: Progressive Relaxation Training
BREATHE
Diaphragmatic BreathingBEHAVIORAL

Diaphragmatic breathing is a way in which people breathe using their diaphragm. This type of breathing has been found to promote relaxation and reduce stress.

Also known as: Deep breathing
BREATHE
Psychoeducation (Placebo)OTHER

DVD-delivered psychoeducation. Participants will view videos that contain information about what anxiety is and information about one's well-being. This condition is an attention placebo control.

Psychoeducation

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Veterans aged 60 years or older.
  • Meets criteria for an anxiety disorder (Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Agoraphobia, Anxiety Disorder Unspecified, Anxiety Disorder Other Specified).
  • English-speaking.

You may not qualify if:

  • Diagnosis of dementia or significant cognitive impairment as determined by a brief cognitive screen.
  • Diagnosis of serious mental illness (bipolar disorder, psychosis, schizophrenia),
  • taking benzodiazepines more than once a week per self report.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1290, United States

Location

Related Publications (1)

  • Gould CE, Carlson C, Wetherell JL, Goldstein MK, Anker L, Beaudreau SA. Brief Video-Delivered Intervention to Reduce Anxiety and Improve Functioning in Older Veterans: Pilot Randomized Controlled Trial. JMIR Aging. 2024 Dec 9;7:e56959. doi: 10.2196/56959.

    PMID: 39652863DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

HypnosisMind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral 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 Health Care System, Palo Alto, CA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2015

First Posted

March 27, 2015

Study Start

December 5, 2018

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

January 31, 2023

Results First Posted

January 31, 2023

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)