Trial Outcomes & Findings for Stress Reduction Techniques and Anxiety: Therapeutic and Neuroendocrine Effects (NCT NCT01033851)

Results Overview

The Hamilton Anxiety Scale (HAMA) was defined as the primary anxiety outcome variable. This scale has 14 items describing symptoms of anxiety, each answered on a 0-4 scale, with 0 for a single question generally representing no symptoms, and 4 representing severe levels of the symptom. The total score is calculated by adding all the items together, for a possible total score of 0 to 56.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

89 participants

Primary outcome timeframe

2 months

Results posted on

2014-06-04

Participant Flow

Participants were recruited by media advertisement and referral between December 2008 and February 2011.

Participant milestones

Participant milestones
Measure	Mindfulness Based Stress Reduction Weekly 2 hour class, given for 8 weeks total.	Stress Management Education Weekly 2 hour class, given for 8 weeks total.
Overall Study STARTED	48	41
Overall Study COMPLETED	45	34
Overall Study NOT COMPLETED	3	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Mindfulness Based Stress Reduction Weekly 2 hour class, given for 8 weeks total.	Stress Management Education Weekly 2 hour class, given for 8 weeks total.
Overall Study Withdrawal by Subject	3	7

Baseline Characteristics

Stress Reduction Techniques and Anxiety: Therapeutic and Neuroendocrine Effects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mindfulness Based Stress Reduction n=48 Participants Weekly 2 hour class, given for 8 weeks total.	Stress Management Education n=41 Participants Weekly 2 hour class, given for 8 weeks total.	Total n=89 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	44 Participants n=5 Participants	40 Participants n=7 Participants	84 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Age, Continuous	41 years STANDARD_DEVIATION 14 • n=5 Participants	37 years STANDARD_DEVIATION 12 • n=7 Participants	39 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	22 Participants n=7 Participants	45 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	19 Participants n=7 Participants	44 Participants n=5 Participants
Region of Enrollment United States	48 participants n=5 Participants	41 participants n=7 Participants	89 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 months

Population: The population analyzed included all participants who attended at least one class of an intervention.

The Hamilton Anxiety Scale (HAMA) was defined as the primary anxiety outcome variable. This scale has 14 items describing symptoms of anxiety, each answered on a 0-4 scale, with 0 for a single question generally representing no symptoms, and 4 representing severe levels of the symptom. The total score is calculated by adding all the items together, for a possible total score of 0 to 56.

Outcome measures

Outcome measures
Measure	Mindfulness Based Stress Reduction n=48 Participants Weekly 2 hour class, given for 8 weeks total.	Stress Management Education n=41 Participants Weekly 2 hour class, given for 8 weeks total.
Active Symptoms of Generalized Anxiety Disorder	13.65 units on a scale Standard Deviation 7.01	16.27 units on a scale Standard Deviation 7.26

SECONDARY outcome

Timeframe: 2 months

Population: The population analyzed included all participants attending at least one class of an intervention.

This is an overal clinical measure of anxiety symptoms after examining and interviewing the patient. The scale is one global item, that scores from 1 (1= not ill at all) to 7 (7= among the most extremely ill).

Outcome measures

Outcome measures
Measure	Mindfulness Based Stress Reduction n=48 Participants Weekly 2 hour class, given for 8 weeks total.	Stress Management Education n=41 Participants Weekly 2 hour class, given for 8 weeks total.
Clinical Global Impression of Severity (CGIS) of Anxiety Symptoms.	3.15 units on a scale Standard Deviation 1.11	3.58 units on a scale Standard Deviation 1.28

Adverse Events

Mindfulness Based Stress Reduction

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Stress Management Education

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Mindfulness Based Stress Reduction n=48 participants at risk Weekly 2 hour class, given for 8 weeks total.	Stress Management Education n=41 participants at risk Weekly 2 hour class, given for 8 weeks total.
Musculoskeletal and connective tissue disorders muscle soreness	2.1% 1/48 • Number of events 1 • 2 months A validated questionnaire was used to assess adverse events.	0.00% 0/41 • 2 months A validated questionnaire was used to assess adverse events.
Nervous system disorders sleep disruption	0.00% 0/48 • 2 months A validated questionnaire was used to assess adverse events.	2.4% 1/41 • Number of events 1 • 2 months A validated questionnaire was used to assess adverse events.

Additional Information

Dr. Elizabeth Hoge

Massachusetts General Hospital

Phone: 6177240859

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place