Relaxation Treatment for Anxiety in Adults Aged 60 or Older (BREATHE)
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|ClinicalTrials.gov Identifier: NCT02429778|
Recruitment Status : Completed
First Posted : April 29, 2015
Results First Posted : January 27, 2020
Last Update Posted : January 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Anxiety Disorders||Behavioral: Diaphragmatic Breathing Behavioral: Progressive Muscle Relaxation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Behavioral Intervention (relaxation, breathing, activity engagement)|
|Masking:||None (Open Label)|
|Official Title:||Reducing Late-Life Anxiety and Improving Functioning With Self-Directed Relaxation|
|Actual Study Start Date :||May 2015|
|Actual Primary Completion Date :||June 2017|
|Actual Study Completion Date :||June 2017|
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
Deep or diaphragmatic breathing is taught prior to relaxation.
Other Name: Deep breathing
Behavioral: Progressive Muscle Relaxation
Tensing and releasing muscle groups in a specified order to help reduce tension and anxiety.
Other Name: Progressive Relaxation Training
No Intervention: 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02429778
|United States, California|
|VA Palo Alto Health Care System|
|Palo Alto, California, United States, 94089|
|Principal Investigator:||Christine E Gould, PhD||VA Palo Alto/Stanford University|