Generalized Anxiety Disorder
Conditions
Brief summary
Current therapies for Generalized Anxiety Disorder (GAD) have limited effectiveness. This study measures the efficacy of two different approaches to reducing anxiety and stress. One approach uses education, nutrition, exercise, and time management training, and another uses mindfulness meditation and yoga, which is taught as part of the Mindfulness-based stress reduction (MBSR) course, an 8-week manualized mindfulness intervention. We hypothesize that the two approaches will reduce anxiety in individuals with GAD in different ways. We will measure changes in stress hormones associated with these changes.
Interventions
BEHAVIORALMindfulness Based Stress Reduction
8 week course
BEHAVIORALStress Management Education
8 week course
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults with generalized anxiety disorder * medically healthy
Exclusion criteria
* substance abuse * history of other psychiatric diagnoses such as psychosis, Obsessive Compulsive Disorder, PTSD * use of certain types of psychotherapy, meditation training, yoga * pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Active Symptoms of Generalized Anxiety Disorder | 2 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impression of Severity (CGIS) of Anxiety Symptoms. | 2 months | 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). |
Countries
United States
Participant flow
Recruitment details
Participants were recruited by media advertisement and referral between December 2008 and February 2011.
Participants by arm
| Arm | Count |
|---|---|
| Mindfulness Based Stress Reduction Weekly 2 hour class, given for 8 weeks total. | 48 |
| Stress Management Education Weekly 2 hour class, given for 8 weeks total. | 41 |
| Total | 89 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 3 | 7 |
Baseline characteristics
| Characteristic | Stress Management Education | Mindfulness Based Stress Reduction | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 4 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants | 44 Participants | 84 Participants |
| Age, Continuous | 37 years STANDARD_DEVIATION 12 | 41 years STANDARD_DEVIATION 14 | 39 years STANDARD_DEVIATION 13 |
| Region of Enrollment United States | 41 participants | 48 participants | 89 participants |
| Sex: Female, Male Female | 22 Participants | 23 Participants | 45 Participants |
| Sex: Female, Male Male | 19 Participants | 25 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 48 | 1 / 41 |
| serious Total, serious adverse events | 0 / 48 | 0 / 41 |
Outcome results
Primary
Active Symptoms of Generalized Anxiety Disorder
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
Population: The population analyzed included all participants who attended at least one class of an intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness Based Stress Reduction | Active Symptoms of Generalized Anxiety Disorder | 13.65 units on a scale | Standard Deviation 7.01 |
| Stress Management Education | Active Symptoms of Generalized Anxiety Disorder | 16.27 units on a scale | Standard Deviation 7.26 |
Secondary
Clinical Global Impression of Severity (CGIS) of Anxiety Symptoms.
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
Population: The population analyzed included all participants attending at least one class of an intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness Based Stress Reduction | Clinical Global Impression of Severity (CGIS) of Anxiety Symptoms. | 3.15 units on a scale | Standard Deviation 1.11 |
| Stress Management Education | Clinical Global Impression of Severity (CGIS) of Anxiety Symptoms. | 3.58 units on a scale | Standard Deviation 1.28 |
Comparison: 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).p-value: 0.0366ANOVA