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| Name | Class |
|---|---|
| University of Bergen | OTHER |
| Norwegian University of Science and Technology | OTHER |
| University of Oslo | OTHER |
| University of California, Berkeley |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT augmented with physical exercise | Experimental | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioural Therapy | Behavioral | Cognitive behavioural therapy conducted individually. 10 weekly sessions, first session lasts 90 minutes, the remaining sessions last 45 minutes. |
| 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) |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Function and structure of prefrontal lobes and limbic system | Functional Magnetic Resonance Imaging (fMRI) conducted with a 3-Tesla scanner. | Baseline, post-treatment (up to 20 weeks after baseline) and 12 months follow-up |
| Blood samples |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anders Hovland, PhD | Solli DPS, University of Bergen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Solli DPS | Bergen | Nesttun | 5228 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37468978 | Derived | Sirevag K, Stavestrand SH, Sjobo T, Endal TB, Nordahl HM, Andersson E, Nordhus IH, Rekdal A, Specht K, Hammar A, Halmoy A, Mohlman J, Hjelmervik H, Thayer JF, Hovland A. Physical exercise augmented cognitive behaviour therapy for older adults with generalised anxiety disorder (PEXACOG): a feasibility study for a randomized controlled trial. Biopsychosoc Med. 2023 Jul 19;17(1):25. doi: 10.1186/s13030-023-00280-7. | |
| 30885256 |
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| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D009043 | Motor Activity |
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| OTHER |
| William Paterson University of New Jersey | OTHER |
| Ohio State University | OTHER |
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| Physical Exercise | Behavioral | Manualised exercise. 15 weekly sessions with instructor, and two weekly unsupervised sessions performed individually. |
|
| Placebo control | Behavioral | 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. |
|
|
| 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 |
Serum concentrations of mature and pro brain-derived neurotropic factor
| 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 |
| Saliva samples | To measure cortisol | 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 |
| Three subtests from Delis-Kaplan Executive Function System battery (D-KEFS; Delis, Kaplan & Kramer, 2001) | Measures executive function | Baseline, post-treatment (up to 20 weeks after baseline) and 12 months follow-up |
| Wisconsin Card Sorting Test: Computer Version 4 research edition (WCST-CV4; Heaton, PAR staff & Goldin 2003). | Measures executive function | Baseline, post-treatment (up to 20 weeks after baseline) and 12 months follow-up |
| The California Verbal Learning Test (CVLT; Delis, Kramer & Kaplan, 1994). | Measures memory | Baseline, post-treatment (up to 20 weeks after baseline) and 12 months follow-up |
| Wechsler Abbreviated Scale of Intelligence | Two subtests from Wechsler Abbreviated Scale of Intelligence (WASI; Wechsler, 1999) will be administered to assess IQ level. | Baseline |
| Ambulatory Electrocardiogram (ECG) | Measures heart rate variability (HRV) | 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 |
| Ekblom-Bak submaximal ergometer cycle test | Test for prediction of VO2 max, which gives an indication of physical fitness | 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 |
| Strength test battery | Measures submaximal physical strength, which gives an indication of physical fitness. | 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 |
| Derived |
| Stavestrand SH, Sirevag K, Nordhus IH, Sjobo T, Endal TB, Nordahl HM, Specht K, Hammar A, Halmoy A, Martinsen EW, Andersson E, Hjelmervik H, Mohlman J, Thayer JF, Hovland A. Physical exercise augmented cognitive behaviour therapy for older adults with generalised anxiety disorder (PEXACOG): study protocol for a randomized controlled trial. Trials. 2019 Mar 18;20(1):174. doi: 10.1186/s13063-019-3268-9. |
| D009068 |
| Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |