Physical exercise augmented cognitive behaviour therapy for older adults with generalised anxiety disorder (PEXACOG): study protocol for a randomized controlled trial

• Published in: Current controlled trials in cardiovascular medicine 2019-03, Vol.20 (1), p.174-14, Article 174
• Main Authors: Stavestrand, Silje Haukenes, Sirevåg, Kristine, Nordhus, Inger Hilde, Sjøbø, Trond, Endal, Trygve Bruun, Nordahl, Hans M, Specht, Karsten, Hammar, Åsa, Halmøy, Anne, Martinsen, Egil W, Andersson, Eva, Hjelmervik, Helene, Mohlman, Jan, Thayer, Julian F, Hovland, Anders
• Format: Article
• Language: English
• Subjects: Adults; Age; Aged; Ambulatory care facilities; Anxiety; Anxiety disorders; Anxiety Disorders - therapy; Behavior modification; Behavioral medicine; Brain research; Brain-derived neurotrophic factor; Cardiovascular diseases; Care and treatment; CBT; Cognition & reasoning; Cognitive ability; Cognitive Behavioral Therapy; Cognitive behavioural therapy; Comorbidity; Coronary heart disease; Executive function; Exercise; GAD; Generalised anxiety disorder; Gerontology; Health aspects; Heart diseases; Humans; Investigations; Magnetic Resonance Imaging; Medicin/Teknik; Medicine/Technology; Middle Aged; Neuropsychology; Older adults; Older people; Physical exercise; Psychiatric hospitals; Randomized Controlled Trials as Topic; RCT; Single-Blind Method; Skills; Study Protocol; Substance abuse
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-019-3268-9

Generalised anxiety disorder (GAD) is a frequent and severe anxiety disorder among older adults. GAD increases the risk of developing other disorders such as depression and coronary heart disease. Older adults with GAD exhibit a poorer response to cognitive behaviour therapy (CBT) compared to younger patients with GAD. The normal age-related cognitive decline can be a contributor to reduced treatment efficacy. One strategy for improving treatment efficacy is to combine CBT with adjunctive interventions targeted at improving cognitive functions. Physical exercise is a viable intervention in this regard. Increased levels of brain-derived neurotrophic factor may mediate improvement in cognitive function. The present study aims to investigate the proposed effects and mechanisms related to concomitant physical exercise. The sample comprises 70 participants aged 60-75 years, who have GAD. Exclusion criteria comprise substance abuse and unstable medication; inability to participate in physical exercise; and conditions which precludes GAD as primary diagnosis. The interventions are individual treatment in the outpatient clinic at the local psychiatric hospital, with two experimental arms: (1) CBT + physical exercise and (2) CBT + telephone calls. The primary outcome measure is symptom reduction on the Penn State Worry Questionnaire. Other measures include questionnaires, clinical interviews, physiological, biological and neuropsychological tests. A subset of 40 participants will undergo magnetic resonance imaging (MRI). After inclusion, participants undergo baseline testing, and are subsequently randomized to a treatment condition. Participants attend five sessions of the add-on treatment in the pre-treatment phase, and move on to interim testing. After interim testing, participants attend 10 sessions of CBT in parallel with continued add-on treatment. Participants are tested post-intervention within 2 weeks of completing treatment, with follow-up testing 6 and 12 months later. This study aims to develop better treatment for GAD in older adults. Enhancing treatment response will be valuable from both individual and societal perspectives, especially taking the aging of the general population into account. ClinicalTrials.gov, NCT02690441 . Registered on 24 February 2016.