Physical Exercise Augmented CBT for GAD
Not Applicable
Active, not recruiting
- Conditions
- Generalized Anxiety Disorder
- Interventions
- Behavioral: Cognitive Behavioural TherapyBehavioral: Placebo controlBehavioral: Physical Exercise
- 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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CBT augmented with physical exercise Cognitive Behavioural Therapy Patients receive 10 sessions of cognitive behavioural therapy for generalized anxiety disorder. Patients also receive 5 weeks of physical exercise pre-treatment, and 10 weeks of physical exercise alongside CBT. Both treatment and physical exercise is administered individually. CBT and placebo control Placebo control Patients receive 10 sessions of cognitive behavioural therapy for generalized anxiety disorder. Patients also receive 5 weeks of placebo control (15 minutes telephone follow-up call each week) pre-treatment, and 10 weeks of attention placebo alongside CBT. Both treatment and placebo control is administered individually. CBT and placebo control Cognitive Behavioural Therapy Patients receive 10 sessions of cognitive behavioural therapy for generalized anxiety disorder. Patients also receive 5 weeks of placebo control (15 minutes telephone follow-up call each week) pre-treatment, and 10 weeks of attention placebo alongside CBT. Both treatment and placebo control is administered individually. CBT augmented with physical exercise Physical Exercise Patients receive 10 sessions of cognitive behavioural therapy for generalized anxiety disorder. Patients also receive 5 weeks of physical exercise pre-treatment, and 10 weeks of physical exercise alongside CBT. Both treatment and physical exercise is administered individually.
- 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 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 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
Trial Locations
- Locations (1)
Solli DPS
🇳🇴Bergen, Nesttun, Norway