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

Abstract

BackgroundGeneralised 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.MethodsThe 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.DiscussionThis 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.Trial registrationClinicalTrials.gov, NCT02690441. Registered on 24 February 2016.Electronic supplementary materialThe online version of this article (10.1186/s13063-019-3268-9) contains supplementary material, which is available to authorized users.

Physical exercise as an add-on treatment to cognitive behavioural therapy for anxiety: a systematic review

“…BDNF reliably increases from PE (Szuhany et al, 2015), and has specifically been highlighted as a potential mechanism for improving the effects of other exposure-based therapies, such as CBT (Kobayashi et al, 2005). The positive effects of PE on cognition and executive functions have also been related to the potential augmentative effects PE on CBT (Stavestrand et al, 2019), as effective executive functioning appears an important pre-requisite for effective cognitive restructuring (Mohlman, 2008;Yochim et al, 2013). As such, PE could potentially be a potent and beneficial add-on intervention to augment the effect of CBT or pharmacotherapies.…”

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

“…An increase in BDNF levels through PE can enhance the ability to learn and remember new material. These effects are hypothesised to an enhancement of the effect of CBT in older adults with GAD [ 16 ].…”

“…The main aim of this study is to investigate the feasibility of the combination of CBT and PE in a sample of older adults with GAD as a precursor to a RCT. The RCT study protocol has been published elsewhere [ 16 ].…”

Physical Exercise and Serum BDNF Levels: Accounting for the Val66Met Polymorphism in Older Adults

“…We conducted the current study in connection with the ongoing Physical Exercise Augmented Cognitive Behavior Therapy for Older Adults With Generalized Anxiety Disorder trial. Our sample consisted of a group of healthy older adults who were to be matched against baseline data in an ongoing clinical trial ( Stavestrand et al, 2019 ).…”

“…The Ekblom-Bak Test consists of 4 minutes of cycling with an initial standardized light intensity level of 60 rpm with a resistance of 30W, followed by 4 minutes of individually targeted cycling with moderate intensity following standardized levels of resistance until participants reach a level between 12 and 15 on Borg’s rating of perceived exertion (60 rpm) ( Björkman et al, 2016 ; Borg, 1970 ). The following 20 minutes of cycling had no criteria regarding load or step frequency but did require that each individual’s heart rate (HR) aim for ≥65% of the estimated maximum HR ( Stavestrand et al, 2019 ), which was calculated using the formula: HR max = 208 − (0.7 × age) ( Tanaka et al, 2001 ).…”