Trial Outcomes & Findings for Does Treating Anxiety Symptoms With ACT Improve Vascular Inflammation and Function? (NCT NCT02915874)
NCT ID: NCT02915874
Last Updated: 2019-07-05
Results Overview
Self-report measure of anxiety. The test consists of 21 questions graded on a scale of 0 (not at all) to 3 (severely). Range of total score is 0 to 63. Higher scores indicate more severe anxiety symptoms.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
72 participants
Primary outcome timeframe
Baseline, 6 weeks and 12 weeks
Results posted on
2019-07-05
Participant Flow
Participant milestones
| Measure |
Acceptance and Commitment Therapy Behavioral Intervention
Subjects randomized to the ACT Intervention group will attend a 1-day group workshop in which two broad areas will be covered:
1. Behavioral Change training will involve a) teaching subjects how to recognize ineffective patterns of behavior and habits, b) exploring and setting life goals and those related to mental and physical health, and c) promoting effective and committed actions to achieve these goals despite the urge to do otherwise;
2. Mindfulness and Acceptance Training will emphasize new ways of managing troubling thoughts, feelings, and physical sensations (i.e. learning how to recognize, and develop cognitive distances from unhelpful thoughts such as "I can't take this anymore" and learning how to willingly face experiences that cannot be changed). In-session exercises and practice will be heavily emphasized during the group intervention and handouts will be distributed for home use.
Acceptance and Commitment Therapy
|
Control
Subjects randomized to not receive treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
28
|
|
Overall Study
Week 6 Follow Up
|
41
|
26
|
|
Overall Study
COMPLETED
|
38
|
22
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
Acceptance and Commitment Therapy Behavioral Intervention
Subjects randomized to the ACT Intervention group will attend a 1-day group workshop in which two broad areas will be covered:
1. Behavioral Change training will involve a) teaching subjects how to recognize ineffective patterns of behavior and habits, b) exploring and setting life goals and those related to mental and physical health, and c) promoting effective and committed actions to achieve these goals despite the urge to do otherwise;
2. Mindfulness and Acceptance Training will emphasize new ways of managing troubling thoughts, feelings, and physical sensations (i.e. learning how to recognize, and develop cognitive distances from unhelpful thoughts such as "I can't take this anymore" and learning how to willingly face experiences that cannot be changed). In-session exercises and practice will be heavily emphasized during the group intervention and handouts will be distributed for home use.
Acceptance and Commitment Therapy
|
Control
Subjects randomized to not receive treatment.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
4
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Started New Anxiety Medication
|
0
|
1
|
Baseline Characteristics
Does Treating Anxiety Symptoms With ACT Improve Vascular Inflammation and Function?
Baseline characteristics by cohort
| Measure |
Acceptance and Commitment Therapy Behavioral Intervention
n=44 Participants
Subjects randomized to the ACT Intervention group will attend a 1-day group workshop in which two broad areas will be covered:
1. Behavioral Change training will involve a) teaching subjects how to recognize ineffective patterns of behavior and habits, b) exploring and setting life goals and those related to mental and physical health, and c) promoting effective and committed actions to achieve these goals despite the urge to do otherwise;
2. Mindfulness and Acceptance Training will emphasize new ways of managing troubling thoughts, feelings, and physical sensations (i.e. learning how to recognize, and develop cognitive distances from unhelpful thoughts such as "I can't take this anymore" and learning how to willingly face experiences that cannot be changed). In-session exercises and practice will be heavily emphasized during the group intervention and handouts will be distributed for home use.
Acceptance and Commitment Therapy
|
Control
n=28 Participants
Subjects randomized to not receive treatment.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
37.1 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
34.6 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Body Mass Index
|
26.1 kg/m^2
STANDARD_DEVIATION 4.8 • n=5 Participants
|
29.6 kg/m^2
STANDARD_DEVIATION 6.3 • n=7 Participants
|
27.4 kg/m^2
STANDARD_DEVIATION 5.6 • n=5 Participants
|
|
Education Level
Some College
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Education Level
College Degree
|
22 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Education Level
Graduate or Professional Degree
|
20 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 weeks and 12 weeksPopulation: Subjects dropped out of study
Self-report measure of anxiety. The test consists of 21 questions graded on a scale of 0 (not at all) to 3 (severely). Range of total score is 0 to 63. Higher scores indicate more severe anxiety symptoms.
Outcome measures
| Measure |
Acceptance and Commitment Therapy Behavioral Intervention
n=44 Participants
Subjects randomized to the ACT Intervention group will attend a 1-day group workshop in which two broad areas will be covered:
1. Behavioral Change training will involve a) teaching subjects how to recognize ineffective patterns of behavior and habits, b) exploring and setting life goals and those related to mental and physical health, and c) promoting effective and committed actions to achieve these goals despite the urge to do otherwise;
2. Mindfulness and Acceptance Training will emphasize new ways of managing troubling thoughts, feelings, and physical sensations (i.e. learning how to recognize, and develop cognitive distances from unhelpful thoughts such as "I can't take this anymore" and learning how to willingly face experiences that cannot be changed). In-session exercises and practice will be heavily emphasized during the group intervention and handouts will be distributed for home use.
Acceptance and Commitment Therapy
|
Control
n=28 Participants
Subjects randomized to not receive treatment.
|
|---|---|---|
|
Beck Anxiety Inventory (BAI)
Baseline
|
18.750 score on a scale
Standard Deviation 8.334
|
17.464 score on a scale
Standard Deviation 7.951
|
|
Beck Anxiety Inventory (BAI)
6 weeks
|
13.317 score on a scale
Standard Deviation 8.413
|
16.154 score on a scale
Standard Deviation 8.624
|
|
Beck Anxiety Inventory (BAI)
12 weeks
|
11.053 score on a scale
Standard Deviation 8.077
|
14.727 score on a scale
Standard Deviation 10.315
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks and 12 weeksPopulation: Subjects dropped out.
Self-reported anxiety measures. STAI-Form Y-1 total score. Consists of 20 questions based on a 4-point Likert scale. Range of total score is 20 to 80. Higher scores indicate greater anxiety.
Outcome measures
| Measure |
Acceptance and Commitment Therapy Behavioral Intervention
n=44 Participants
Subjects randomized to the ACT Intervention group will attend a 1-day group workshop in which two broad areas will be covered:
1. Behavioral Change training will involve a) teaching subjects how to recognize ineffective patterns of behavior and habits, b) exploring and setting life goals and those related to mental and physical health, and c) promoting effective and committed actions to achieve these goals despite the urge to do otherwise;
2. Mindfulness and Acceptance Training will emphasize new ways of managing troubling thoughts, feelings, and physical sensations (i.e. learning how to recognize, and develop cognitive distances from unhelpful thoughts such as "I can't take this anymore" and learning how to willingly face experiences that cannot be changed). In-session exercises and practice will be heavily emphasized during the group intervention and handouts will be distributed for home use.
Acceptance and Commitment Therapy
|
Control
n=28 Participants
Subjects randomized to not receive treatment.
|
|---|---|---|
|
State-Trait Anxiety Inventory (STAI) - State Anxiety
Baseline
|
43.227 score on a scale
Standard Deviation 9.246
|
44.143 score on a scale
Standard Deviation 6.980
|
|
State-Trait Anxiety Inventory (STAI) - State Anxiety
6 weeks
|
43.000 score on a scale
Standard Deviation 12.538
|
48.885 score on a scale
Standard Deviation 9.688
|
|
State-Trait Anxiety Inventory (STAI) - State Anxiety
12 weeks
|
39.658 score on a scale
Standard Deviation 11.516
|
42.682 score on a scale
Standard Deviation 10.895
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Data was collected for the first 5 cohorts.
Flow-mediated dilation of the brachial artery will be assessed by ultrasound following a 5 minute distal occlusion. Larger values are better. Data was collected for the first 5 cohorts.
Outcome measures
| Measure |
Acceptance and Commitment Therapy Behavioral Intervention
n=25 Participants
Subjects randomized to the ACT Intervention group will attend a 1-day group workshop in which two broad areas will be covered:
1. Behavioral Change training will involve a) teaching subjects how to recognize ineffective patterns of behavior and habits, b) exploring and setting life goals and those related to mental and physical health, and c) promoting effective and committed actions to achieve these goals despite the urge to do otherwise;
2. Mindfulness and Acceptance Training will emphasize new ways of managing troubling thoughts, feelings, and physical sensations (i.e. learning how to recognize, and develop cognitive distances from unhelpful thoughts such as "I can't take this anymore" and learning how to willingly face experiences that cannot be changed). In-session exercises and practice will be heavily emphasized during the group intervention and handouts will be distributed for home use.
Acceptance and Commitment Therapy
|
Control
n=17 Participants
Subjects randomized to not receive treatment.
|
|---|---|---|
|
Flow-mediated Dilation of the Brachial Artery
Baseline
|
3.448 percentage of flow-mediation dilation
Standard Deviation 4.884
|
5.913 percentage of flow-mediation dilation
Standard Deviation 4.151
|
|
Flow-mediated Dilation of the Brachial Artery
12 weeks
|
4.269 percentage of flow-mediation dilation
Standard Deviation 3.243
|
4.574 percentage of flow-mediation dilation
Standard Deviation 2.231
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Subjects dropped out. There are additional measurements which are missing at random.
Carotid-Femoral PWV (cm/sec)
Outcome measures
| Measure |
Acceptance and Commitment Therapy Behavioral Intervention
n=43 Participants
Subjects randomized to the ACT Intervention group will attend a 1-day group workshop in which two broad areas will be covered:
1. Behavioral Change training will involve a) teaching subjects how to recognize ineffective patterns of behavior and habits, b) exploring and setting life goals and those related to mental and physical health, and c) promoting effective and committed actions to achieve these goals despite the urge to do otherwise;
2. Mindfulness and Acceptance Training will emphasize new ways of managing troubling thoughts, feelings, and physical sensations (i.e. learning how to recognize, and develop cognitive distances from unhelpful thoughts such as "I can't take this anymore" and learning how to willingly face experiences that cannot be changed). In-session exercises and practice will be heavily emphasized during the group intervention and handouts will be distributed for home use.
Acceptance and Commitment Therapy
|
Control
n=28 Participants
Subjects randomized to not receive treatment.
|
|---|---|---|
|
Pulse Wave Velocity (PWV)
Baseline
|
630.335 cm/sec
Standard Deviation 254.534
|
640.811 cm/sec
Standard Deviation 144.177
|
|
Pulse Wave Velocity (PWV)
12 weeks
|
620.608 cm/sec
Standard Deviation 183.534
|
639.938 cm/sec
Standard Deviation 158.349
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Subjects dropped out of study and some measurements are missing at random.
Forearm volume (FAV). Peak Forearm blood flow was assessed by plethysmography (mL/100 mL FAV/min).
Outcome measures
| Measure |
Acceptance and Commitment Therapy Behavioral Intervention
n=39 Participants
Subjects randomized to the ACT Intervention group will attend a 1-day group workshop in which two broad areas will be covered:
1. Behavioral Change training will involve a) teaching subjects how to recognize ineffective patterns of behavior and habits, b) exploring and setting life goals and those related to mental and physical health, and c) promoting effective and committed actions to achieve these goals despite the urge to do otherwise;
2. Mindfulness and Acceptance Training will emphasize new ways of managing troubling thoughts, feelings, and physical sensations (i.e. learning how to recognize, and develop cognitive distances from unhelpful thoughts such as "I can't take this anymore" and learning how to willingly face experiences that cannot be changed). In-session exercises and practice will be heavily emphasized during the group intervention and handouts will be distributed for home use.
Acceptance and Commitment Therapy
|
Control
n=28 Participants
Subjects randomized to not receive treatment.
|
|---|---|---|
|
Forearm Blood Flow
Baseline
|
23.546 mL/100 mL FAV/min
Standard Deviation 8.434
|
19.307 mL/100 mL FAV/min
Standard Deviation 4.943
|
|
Forearm Blood Flow
12 weeks
|
25.181 mL/100 mL FAV/min
Standard Deviation 8.431
|
19.969 mL/100 mL FAV/min
Standard Deviation 7.444
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks and 12 weeksPopulation: Last 3 cohorts were measured. Furthermore measurements are missing at random.
Muscle sympathetic nerve activity will be measured directly through the peroneal nerve over a 30 minute recording. The processed signal for neural activity will be processed as bursts/minute. Data was collected for the last 3 cohorts.
Outcome measures
| Measure |
Acceptance and Commitment Therapy Behavioral Intervention
n=13 Participants
Subjects randomized to the ACT Intervention group will attend a 1-day group workshop in which two broad areas will be covered:
1. Behavioral Change training will involve a) teaching subjects how to recognize ineffective patterns of behavior and habits, b) exploring and setting life goals and those related to mental and physical health, and c) promoting effective and committed actions to achieve these goals despite the urge to do otherwise;
2. Mindfulness and Acceptance Training will emphasize new ways of managing troubling thoughts, feelings, and physical sensations (i.e. learning how to recognize, and develop cognitive distances from unhelpful thoughts such as "I can't take this anymore" and learning how to willingly face experiences that cannot be changed). In-session exercises and practice will be heavily emphasized during the group intervention and handouts will be distributed for home use.
Acceptance and Commitment Therapy
|
Control
n=8 Participants
Subjects randomized to not receive treatment.
|
|---|---|---|
|
Muscle Sympathetic Nerve Activity
Baseline
|
13.890 bursts/minute
Standard Deviation 10.427
|
21.550 bursts/minute
Standard Deviation 11.476
|
|
Muscle Sympathetic Nerve Activity
6 weeks
|
13.343 bursts/minute
Standard Deviation 8.652
|
23.967 bursts/minute
Standard Deviation 13.876
|
|
Muscle Sympathetic Nerve Activity
12 weeks
|
19.104 bursts/minute
Standard Deviation 11.283
|
29.877 bursts/minute
Standard Deviation 11.835
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks and 12 weeksPopulation: Subjects dropped out of study
Self-reported anxiety measure. STAI-Form Y2 total score. Consists of 20 questions based on a 4-point Likert scale. Range of total score is 20 to 80. Higher scores indicate greater anxiety.
Outcome measures
| Measure |
Acceptance and Commitment Therapy Behavioral Intervention
n=44 Participants
Subjects randomized to the ACT Intervention group will attend a 1-day group workshop in which two broad areas will be covered:
1. Behavioral Change training will involve a) teaching subjects how to recognize ineffective patterns of behavior and habits, b) exploring and setting life goals and those related to mental and physical health, and c) promoting effective and committed actions to achieve these goals despite the urge to do otherwise;
2. Mindfulness and Acceptance Training will emphasize new ways of managing troubling thoughts, feelings, and physical sensations (i.e. learning how to recognize, and develop cognitive distances from unhelpful thoughts such as "I can't take this anymore" and learning how to willingly face experiences that cannot be changed). In-session exercises and practice will be heavily emphasized during the group intervention and handouts will be distributed for home use.
Acceptance and Commitment Therapy
|
Control
n=28 Participants
Subjects randomized to not receive treatment.
|
|---|---|---|
|
State-Trait Anxiety Inventory (STAI) - Trait Anxiety
Baseline
|
53.205 score on a scale
Standard Deviation 7.893
|
56.179 score on a scale
Standard Deviation 8.748
|
|
State-Trait Anxiety Inventory (STAI) - Trait Anxiety
6 weeks
|
46.902 score on a scale
Standard Deviation 11.975
|
53.846 score on a scale
Standard Deviation 9.456
|
|
State-Trait Anxiety Inventory (STAI) - Trait Anxiety
12 weeks
|
44.842 score on a scale
Standard Deviation 11.305
|
51.136 score on a scale
Standard Deviation 9.662
|
Adverse Events
Acceptance and Commitment Therapy Behavioral Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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