Trial Outcomes & Findings for Relaxation Treatment for Anxiety in Adults Aged 60 or Older (NCT NCT02429778)
NCT ID: NCT02429778
Last Updated: 2020-01-27
Results Overview
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.
COMPLETED
NA
40 participants
Change from baseline to 8 weeks
2020-01-27
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
13
|
20
|
|
Overall Study
NOT COMPLETED
|
7
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
5
|
0
|
Baseline Characteristics
Relaxation Treatment for Anxiety in Adults Aged 60 or Older
Baseline characteristics by cohort
| Measure |
BREATHE
n=20 Participants
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.
|
Wait List
n=20 Participants
8 week wait list period. Participants assigned to wait list will have the opportunity to receive BREATHE arm after 8 weeks if interested.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Geriatric Anxiety Scale
|
20.85 units on a scale
STANDARD_DEVIATION 8.38 • n=5 Participants
|
22.90 units on a scale
STANDARD_DEVIATION 10.98 • n=7 Participants
|
21.88 units on a scale
STANDARD_DEVIATION 9.70 • n=5 Participants
|
|
Somatic Symptom Scale 8-item
|
9.50 units on a scale
STANDARD_DEVIATION 4.74 • n=5 Participants
|
8.80 units on a scale
STANDARD_DEVIATION 5.63 • n=7 Participants
|
9.15 units on a scale
STANDARD_DEVIATION 5.15 • n=5 Participants
|
|
Age, Continuous
|
68.40 years
STANDARD_DEVIATION 6.77 • n=5 Participants
|
69.45 years
STANDARD_DEVIATION 7.61 • n=7 Participants
|
68.93 years
STANDARD_DEVIATION 7.13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White/Non-Hispanic
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White/Hispanic
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Patients Health Questionnaire 9-item
|
8.40 units on a scale
STANDARD_DEVIATION 5.55 • n=5 Participants
|
6.80 units on a scale
STANDARD_DEVIATION 5.48 • n=7 Participants
|
7.60 units on a scale
STANDARD_DEVIATION 5.50 • n=5 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to 8 weeksPopulation: A linear mixed effects model using maximum likelihood modeling was employed to analyze these data using intent-to-treat principles.
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.
Outcome measures
| Measure |
BREATHE
n=20 Participants
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.
|
Wait List
n=20 Participants
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
|
17.95 score on a scale
Standard Error 2.34
|
26.2 score on a scale
Standard Error 2.14
|
PRIMARY outcome
Timeframe: Change from baseline to 8 weeksPopulation: A linear mixed effects model using maximum likelihood modeling was employed to analyze these data using intent-to-treat principles.
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.
Outcome measures
| Measure |
BREATHE
n=20 Participants
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.
|
Wait List
n=19 Participants
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 Activity Engagement
Baseline
|
49.97 units on a scale
Standard Error 3.04
|
50.15 units on a scale
Standard Error 2.83
|
|
Change in Activity Engagement
8 weeks
|
54.97 units on a scale
Standard Error 3.57
|
48.23 units on a scale
Standard Error 3.51
|
SECONDARY outcome
Timeframe: Change from baseline to 8 weeksPopulation: A linear mixed effects model using maximum likelihood modeling was employed to analyze these data using intent-to-treat principles.
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.
Outcome measures
| Measure |
BREATHE
n=20 Participants
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.
|
Wait List
n=20 Participants
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 Depressive Symptoms
Baseline
|
8.40 units on a scale
Standard Error 1.24
|
6.80 units on a scale
Standard Error 1.23
|
|
Change in Depressive Symptoms
8 weeks
|
5.71 units on a scale
Standard Error 1.58
|
8.6 units on a scale
Standard Error 1.19
|
SECONDARY outcome
Timeframe: Change from baseline to 8 weeksPopulation: A linear mixed effects model using maximum likelihood modeling was employed to analyze these data using intent-to-treat principles.
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.
Outcome measures
| Measure |
BREATHE
n=20 Participants
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.
|
Wait List
n=20 Participants
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 Somatic Symptoms
Baseline
|
9.50 units on a scale
Standard Error 1.06
|
8.80 units on a scale
Standard Error 1.26
|
|
Change in Somatic Symptoms
8 weeks
|
6.64 units on a scale
Standard Error 1.07
|
10.30 units on a scale
Standard Error 1.28
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline to 8 weeksHeart rate will be measured at baseline and at 8 weeks after enrollment. This is an exploratory measure.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline to 8 weeksBlood pressure will be measured at baseline and at 8 weeks after enrollment. This is an exploratory measure.
Outcome measures
Outcome data not reported
Adverse Events
BREATHE
Wait List
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place