Generalized Anxiety Disorder
Conditions
Brief summary
The purpose of this study is to determine whether acceptance-based behavior therapy for GAD results in greater symptom reduction and increased quality of life than applied relaxation.
Interventions
BEHAVIORALAcceptance based behavioral therapy
16 individual psychotherapy sessions focused on psychoeducation about anxiety, anxious responding, the function of emotions, mindfulness, and problems with efforts to constrict one's emotional experience; training in mindfulness skills; practice applying mindfulness skills in daily life, including acceptance of, rather than efforts to control, internal experience; and identification of values in areas of life and practice engaging in chosen actions.
BEHAVIORALApplied relaxation
16 sessions of individual psychotherapy focused on psychoeducation about anxiety and anxious responding; training in multiple forms of relaxation; early cue detection; and practice applying relaxation in daily life.
Sponsors
National Institute of Mental Health (NIMH)
University of Massachusetts, Boston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* principal diagnosis of GAD * at least moderate (4 on a scale from 0 to 8) on the ADIS Severity Scale for GAD symptoms * willing to maintain current psychotropic medication levels (and have been stabilized on any current medications for at least three months) and refrain from other psychosocial treatments for anxiety or mood problems during the course of therapy * fluent in English * 18 years or older
Exclusion criteria
* bipolar disorder * psychotic disorders * substance dependence * active suicidal intent * if anxious symptomatology is due to a medical/physical condition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anxiety Disorders Interview Schedule for DSM-IV, Clinician Severity Rating of GAD | pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up |
| Hamilton Anxiety Rating Scale | pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up |
| Penn State Worry Questionnaire | pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up |
Secondary
| Measure | Time frame |
|---|---|
| Beck Depression Inventory - II | pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up |
| Quality of Life Inventory | pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up |
Countries
United States
Outcome results
None listed