PEXACOG: Physical Exercise Augmented CBT for GAD
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Behavioral: Cognitive Behavioural Therapy
Cognitive behavioural therapy conducted individually. 10 weekly sessions, first session lasts 90 minutes, the remaining sessions last 45 minutes.
Behavioral: Physical Exercise
Manualised exercise. 15 weekly sessions with instructor, and two weekly unsupervised sessions performed individually.
|
| Active Comparator: 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. |
Behavioral: Cognitive Behavioural Therapy
Cognitive behavioural therapy conducted individually. 10 weekly sessions, first session lasts 90 minutes, the remaining sessions last 45 minutes.
Behavioral: Placebo 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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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]
Other Outcome Measures
- Function and structure of prefrontal lobes and limbic system [Baseline, post-treatment (up to 20 weeks after baseline) and 12 months follow-up]
Functional Magnetic Resonance Imaging (fMRI) conducted with a 3-Tesla scanner.
- Blood samples [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]
Serum concentrations of mature and pro brain-derived neurotropic factor
- Saliva samples [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]
To measure cortisol
- Three subtests from Delis-Kaplan Executive Function System battery (D-KEFS; Delis, Kaplan & Kramer, 2001) [Baseline, post-treatment (up to 20 weeks after baseline) and 12 months follow-up]
Measures executive function
- Wisconsin Card Sorting Test: Computer Version 4 research edition (WCST-CV4; Heaton, PAR staff & Goldin 2003). [Baseline, post-treatment (up to 20 weeks after baseline) and 12 months follow-up]
Measures executive function
- The California Verbal Learning Test (CVLT; Delis, Kramer & Kaplan, 1994). [Baseline, post-treatment (up to 20 weeks after baseline) and 12 months follow-up]
Measures memory
- Wechsler Abbreviated Scale of Intelligence [Baseline]
Two subtests from Wechsler Abbreviated Scale of Intelligence (WASI; Wechsler, 1999) will be administered to assess IQ level.
- Ambulatory Electrocardiogram (ECG) [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]
Measures heart rate variability (HRV)
- Ekblom-Bak submaximal ergometer cycle test [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]
Test for prediction of VO2 max, which gives an indication of physical fitness
- Strength test battery [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]
Measures submaximal physical strength, which gives an indication of physical fitness.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Primary diagnosis of GAD
Exclusion Criteria:
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Substance abuse
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Use of benzodiazepines, use of antipsychotica
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Lack of ability to stabilize other psychotropic medication during participating in the study
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Medical condition that precludes participation in physical exercise
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Severe major depression as determined by the MINI International Neuropsychiatric Interview
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Life-time history of psychosis and/or mania
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Participation in other ongoing psychotherapy
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Organic brain disease
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Positive screening for dementia with Mini Mental State Examination
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Currently engaged in a regular physical exercise program
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Solli DPS | Bergen | Nesttun | Norway | 5228 |
Sponsors and Collaborators
- 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
Investigators
- Principal Investigator: Anders Hovland, PhD, Solli DPS, University of Bergen
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 971427272T1