Generalized Anxiety Disorder
Conditions
Keywords
GAD, CBT, Physical exercise, Older adults
Brief summary
Generalised anxiety disorder (GAD) is a severe and debilitating anxiety disorder that is highly prevalent among older adults. Anxiety and GAD is a well-documented risk factor for the development of other severe conditions such as depression and dementia, and effective treatments are called for. However, recommended treatment for GAD has consistently been found to yield blunted response rates for older adults compared to younger patients. The purpose of this study is to evaluate the effects of exercise-augmented cognitive behaviour therapy for older adults with GAD. Exercise augmented CBT is expected to yield better results than standard CBT in terms of greater reduction of symptoms and increased rates of remission. The investigators will also investigate the effects of treatment on biological, physiological and neuropsychological measures.
Interventions
BEHAVIORALCognitive Behavioural Therapy
Cognitive behavioural therapy conducted individually. 10 weekly sessions, first session lasts 90 minutes, the remaining sessions last 45 minutes.
BEHAVIORALPhysical Exercise
Manualised exercise. 15 weekly sessions with instructor, and two weekly unsupervised sessions performed individually.
BEHAVIORALPlacebo control
One follow-up telephone call à 15 minutes each week for 15 weeks. Aims to control for therapist contact in physical exercise condition and total duration of treatment.
Sponsors
Solli Distriktspsykiatriske Senter
University of Bergen
Norwegian University of Science and Technology
University of Oslo
University of California, Berkeley
William Paterson University of New Jersey
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Primary diagnosis of GAD
Exclusion criteria
* Substance abuse * Use of benzodiazepines, use of antipsychotica * Lack of ability to stabilize other psychotropic medication during participating in the study * Medical condition that precludes participation in physical exercise * Severe major depression as determined by the MINI International Neuropsychiatric Interview * Life-time history of psychosis and/or mania * Participation in other ongoing psychotherapy * Organic brain disease * Positive screening for dementia with Mini Mental State Examination * Currently engaged in a regular physical exercise program
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in The Penn State Worry Questionnaire | Baseline, after pre-treatment (up to 8 weeks after baseline), post-treatment (up to 20 weeks after baseline), 6 months follow-up and 12 months follow-up | Assesses symptom severity of GAD |
| Change in clinical diagnosis after treatment assessed by independent, blinded rater with Anxiety Disorders Interview Schedule (ADIS-IV) | Baseline and post-treatment (up to 20 weeks after baseline) | Remission rates. Assessed by independent, blinded rater with Anxiety Disorders Interview Schedule (ADIS-IV) |
Secondary
| Measure | Time frame |
|---|---|
| Geriatric Anxiety Inventory | Baseline, after pre-treatment (up to 8 weeks after baseline), post-treatment (up to 20 weeks after baseline), 6 months follow-up and 12 months follow-up |
| Generalized Anxiety Disorder 7-item scale (GAD-7) | Baseline, after pre-treatment (up to 8 weeks after baseline), post-treatment (up to 20 weeks after baseline), 6 months follow-up and 12 months follow-up |
| Beck Anxiety Inventory | Baseline, after pre-treatment (up to 8 weeks after baseline), post-treatment (up to 20 weeks after baseline), 6 months follow-up and 12 months follow-up |
| Beck Depression Inventory - II | Baseline, after pre-treatment (up to 8 weeks after baseline), post-treatment (up to 20 weeks after baseline), 6 months follow-up and 12 months follow-up |
| Bergen Insomnia Scale | Baseline, after pre-treatment (up to 8 weeks after baseline), post-treatment (up to 20 weeks after baseline), 6 months follow-up and 12 months follow-up |
| Quality of Life Inventory | Baseline, after pre-treatment (up to 8 weeks after baseline), post-treatment (up to 20 weeks after baseline), 6 months follow-up and 12 months follow-up |
| International Physical Activity Questionnaire (IPAQ) | Baseline, after pre-treatment (up to 8 weeks after baseline), post-treatment (up to 20 weeks after baseline), 6 months follow-up and 12 months follow-up |
| 5-item Treatment Credibility and Expectancy Scale (CES) | Baseline |
Countries
Norway
Contacts
PRINCIPAL_INVESTIGATORAnders Hovland, PhD
Solli DPS, University of Bergen
Outcome results
None listed