Physical Exercise Augmented CBT for GAD

Study Overview
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Brief Summary
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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.

Official Title
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Physical Exercise Augmented Cognitive Behaviour Therapy for Older Adults With Generalised Anxiety Disorder

Conditions
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Generalized Anxiety Disorder

Intervention / Treatment
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* Behavioral: Cognitive Behavioural Therapy
* Behavioral: Physical Exercise
* Behavioral: Placebo control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT augmented with physical exercise<br>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. | Behavioral: Cognitive Behavioural Therapy<br>* Cognitive behavioural therapy conducted individually. 10 weekly sessions, first session lasts 90 minutes, the remaining sessions last 45 minutes.<br>Behavioral: Physical Exercise<br>* Manualised exercise. 15 weekly sessions with instructor, and two weekly unsupervised sessions performed individually.<br>|
| Active Comparator: CBT and placebo control<br>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. | Behavioral: Cognitive Behavioural Therapy<br>* Cognitive behavioural therapy conducted individually. 10 weekly sessions, first session lasts 90 minutes, the remaining sessions last 45 minutes.<br>Behavioral: Placebo control<br>* 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.<br>* Other names: Telephone follow-up;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in The Penn State Worry Questionnaire | Assesses symptom severity of GAD | 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 | 
| Change in clinical diagnosis after treatment assessed by independent, blinded rater with Anxiety Disorders Interview Schedule (ADIS-IV) | Remission rates. Assessed by independent, blinded rater with Anxiety Disorders Interview Schedule (ADIS-IV) | Baseline and post-treatment (up to 20 weeks after baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GAD, CBT, Physical exercise, Older adults