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Stress Reduction Techniques and Anxiety: Therapeutic and Neuroendocrine Effects

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ClinicalTrials.gov Identifier: NCT01033851
Recruitment Status : Completed
First Posted : December 17, 2009
Results First Posted : June 11, 2013
Last Update Posted : June 4, 2014
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Elizabeth A. Hoge, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Generalized Anxiety Disorder
Interventions Behavioral: Mindfulness Based Stress Reduction
Behavioral: Stress Management Education
Enrollment 89
Recruitment Details Participants were recruited by media advertisement and referral between December 2008 and February 2011.
Pre-assignment Details  
Arm/Group Title Mindfulness Based Stress Reduction Stress Management Education
Hide Arm/Group Description Weekly 2 hour class, given for 8 weeks total. Weekly 2 hour class, given for 8 weeks total.
Period Title: Overall Study
Started 48 41
Completed 45 34
Not Completed 3 7
Reason Not Completed
Withdrawal by Subject             3             7
Arm/Group Title Mindfulness Based Stress Reduction Stress Management Education Total
Hide Arm/Group Description Weekly 2 hour class, given for 8 weeks total. Weekly 2 hour class, given for 8 weeks total. Total of all reporting groups
Overall Number of Baseline Participants 48 41 89
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 41 participants 89 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
44
  91.7%
40
  97.6%
84
  94.4%
>=65 years
4
   8.3%
1
   2.4%
5
   5.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 48 participants 41 participants 89 participants
41  (14) 37  (12) 39  (13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 41 participants 89 participants
Female
23
  47.9%
22
  53.7%
45
  50.6%
Male
25
  52.1%
19
  46.3%
44
  49.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 48 participants 41 participants 89 participants
48 41 89
1.Primary Outcome
Title Active Symptoms of Generalized Anxiety Disorder
Hide Description 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.
Time Frame 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
The population analyzed included all participants who attended at least one class of an intervention.
Arm/Group Title Mindfulness Based Stress Reduction Stress Management Education
Hide Arm/Group Description:
Weekly 2 hour class, given for 8 weeks total.
Weekly 2 hour class, given for 8 weeks total.
Overall Number of Participants Analyzed 48 41
Mean (Standard Deviation)
Unit of Measure: units on a scale
13.65  (7.01) 16.27  (7.26)
2.Secondary Outcome
Title Clinical Global Impression of Severity (CGIS) of Anxiety Symptoms.
Hide Description 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).
Time Frame 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
The population analyzed included all participants attending at least one class of an intervention.
Arm/Group Title Mindfulness Based Stress Reduction Stress Management Education
Hide Arm/Group Description:
Weekly 2 hour class, given for 8 weeks total.
Weekly 2 hour class, given for 8 weeks total.
Overall Number of Participants Analyzed 48 41
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.15  (1.11) 3.58  (1.28)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mindfulness Based Stress Reduction, Stress Management Education
Comments A repeated measure ANOVA, with time as the repeated measure, treatment arm as between-subjects factor and CGI-S score as the dependent variable, found a main effect of time (F(1,84)=62.19, p<0.001) and a significant treatment arm X time interaction (F(1,84)=4.51, p=0.0366).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0366
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame 2 months
Adverse Event Reporting Description A validated questionnaire was used to assess adverse events.
 
Arm/Group Title Mindfulness Based Stress Reduction Stress Management Education
Hide Arm/Group Description Weekly 2 hour class, given for 8 weeks total. Weekly 2 hour class, given for 8 weeks total.
All-Cause Mortality
Mindfulness Based Stress Reduction Stress Management Education
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Mindfulness Based Stress Reduction Stress Management Education
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/48 (0.00%)      0/41 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Mindfulness Based Stress Reduction Stress Management Education
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/48 (2.08%)      1/41 (2.44%)    
Musculoskeletal and connective tissue disorders     
muscle soreness   1/48 (2.08%)  1 0/41 (0.00%)  0
Nervous system disorders     
sleep disruption   0/48 (0.00%)  0 1/41 (2.44%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Elizabeth Hoge
Organization: Massachusetts General Hospital
Phone: 6177240859
EMail: ehoge@partners.org
Layout table for additonal information
Responsible Party: Elizabeth A. Hoge, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01033851    
Other Study ID Numbers: 2008-P-000275
5K23AT004432 ( U.S. NIH Grant/Contract )
First Submitted: December 9, 2009
First Posted: December 17, 2009
Results First Submitted: February 21, 2013
Results First Posted: June 11, 2013
Last Update Posted: June 4, 2014