Physical Exercise Augmented CBT for GAD
- Conditions
- Generalized Anxiety Disorder
- Registration Number
- NCT02690441
- Lead Sponsor
- Solli Distriktspsykiatriske Senter
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 53
- Primary diagnosis of GAD
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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)
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
- Secondary Outcome Measures
Name Time Method 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 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 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 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 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 5-item Treatment Credibility and Expectancy Scale (CES) Baseline
Trial Locations
- Locations (1)
Solli DPS
🇳🇴Bergen, Nesttun, Norway
Solli DPS🇳🇴Bergen, Nesttun, Norway