Relaxation Treatment for Anxiety in Adults Aged 60 or Older

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02429778

Acronym

BREATHE

Enrollment

Registered

2015-04-29

Start date

2015-05-31

Completion date

2017-06-30

Last updated

2020-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Disorders

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.

Interventions

BEHAVIORALDiaphragmatic Breathing

Deep or diaphragmatic breathing is taught prior to relaxation.

BEHAVIORALProgressive Muscle Relaxation

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Behavioral Intervention (relaxation, breathing, activity engagement)

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Change in Anxiety Symptoms	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	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

Measure	Time frame	Description
Change in Depressive Symptoms	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	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

Measure	Time frame	Description
Change in Heart Rate	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	Change from baseline to 8 weeks	Blood pressure will be measured at baseline and at 8 weeks after enrollment. This is an exploratory measure.

Countries

United States

Participant flow

Participants by arm

Arm	Count
BREATHE 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. 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.	20
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.	20
Total	40

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	2	0
Overall Study	Withdrawal by Subject	5	0

Baseline characteristics

Characteristic	Wait List	Total	BREATHE
Age, Continuous	69.45 years STANDARD_DEVIATION 7.61	68.93 years STANDARD_DEVIATION 7.13	68.40 years STANDARD_DEVIATION 6.77
Geriatric Anxiety Scale	22.90 units on a scale STANDARD_DEVIATION 10.98	21.88 units on a scale STANDARD_DEVIATION 9.7	20.85 units on a scale STANDARD_DEVIATION 8.38
Patients Health Questionnaire 9-item	6.80 units on a scale STANDARD_DEVIATION 5.48	7.60 units on a scale STANDARD_DEVIATION 5.5	8.40 units on a scale STANDARD_DEVIATION 5.55
Race/Ethnicity, Customized Race/Ethnicity Asian	1 Participants	5 Participants	4 Participants
Race/Ethnicity, Customized Race/Ethnicity Other	2 Participants	2 Participants	0 Participants
Race/Ethnicity, Customized Race/Ethnicity White/Hispanic	3 Participants	5 Participants	2 Participants
Race/Ethnicity, Customized Race/Ethnicity White/Non-Hispanic	14 Participants	28 Participants	14 Participants
Region of Enrollment United States	20 participants	40 participants	20 participants
Sex: Female, Male Female	13 Participants	24 Participants	11 Participants
Sex: Female, Male Male	7 Participants	16 Participants	9 Participants
Somatic Symptom Scale 8-item	8.80 units on a scale STANDARD_DEVIATION 5.63	9.15 units on a scale STANDARD_DEVIATION 5.15	9.50 units on a scale STANDARD_DEVIATION 4.74

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 20	0 / 20
other Total, other adverse events	0 / 20	0 / 20
serious Total, serious adverse events	0 / 20	0 / 20

Outcome results

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.