Physical Exercise Augmented Cognitive Behaviour Therapy for Older Adults With Generalised Anxiety Disorder
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 53
- Locations
- 2
- Primary Endpoint
- Change in clinical diagnosis after treatment assessed by independent, blinded rater with Anxiety Disorders Interview Schedule (ADIS-IV)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
CBT augmented with 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.
Intervention: Physical Exercise (Behavioral)
CBT augmented with 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.
Intervention: Cognitive Behavioural Therapy (Behavioral)
CBT and 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.
Intervention: Cognitive Behavioural Therapy (Behavioral)
CBT and 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.
Intervention: Placebo control (Behavioral)
Outcomes
Primary Outcomes
Change in clinical diagnosis after treatment assessed by independent, blinded rater with Anxiety Disorders Interview Schedule (ADIS-IV)
Time Frame: 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
Time Frame: 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 Outcomes
- 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)