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

Silje Haukenes Stavestrand, Kristine Sirevåg, Inger Hilde Nordhus, Trond Sjøbø, Trygve Bruun Endal, Hans M Nordahl, Karsten Specht, Åsa Hammar, Anne Halmøy, Egil W Martinsen, Eva Andersson, Helene Hjelmervik, Jan Mohlman, Julian F Thayer, Anders Hovland, Silje Haukenes Stavestrand, Kristine Sirevåg, Inger Hilde Nordhus, Trond Sjøbø, Trygve Bruun Endal, Hans M Nordahl, Karsten Specht, Åsa Hammar, Anne Halmøy, Egil W Martinsen, Eva Andersson, Helene Hjelmervik, Jan Mohlman, Julian F Thayer, Anders Hovland

Abstract

Background: 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.

Methods: 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.

Discussion: 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.

Trial registration: ClinicalTrials.gov, NCT02690441 . Registered on 24 February 2016.

Keywords: Brain-derived neurotrophic factor; CBT; Cognitive behavioural therapy; Executive function; GAD; Generalised anxiety disorder; Older adults; Physical exercise; RCT.

Conflict of interest statement

Ethics approval and consent to participate

The Regional Committee for Medical and Health Research Ethics, region North, has approved the study, reference number 2015/2189. All the important protocol modifications are reported to the Regional Committee for Medical and Health Research Ethics for approval, and will be reflected in the scientific reporting of results. The project coordinators provide participants with written and oral information about the study before enrolment. All participants have signed informed consent before enrolment in the study, and the Regional Committee for Medical and Health Research Ethics regulates the use of all data.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Study design. Visual presentation of the study design, including sample, assessments, and interventions. GAD, generalised anxiety disorder; CBT, cognitive behaviour therapy
Fig. 2
Fig. 2
Standard protocol items: recommendation for interventional trials (SPIRIT) figure. Schedule of enrolment, interventions and assessments. Overview of the measures applied in the study. CBT, cognitive behaviour therapy; ADIS-IV, Anxiety Disorders Interview Schedule for DSM-IV; M.I.N.I., Mini International Neuropsychiatric Interview; PSWQ, Penn State Worry Questionnaire; GAD-7, Generalized Anxiety Disorder 7-item scale; IPAQ, International Physical Activity Questionnaire; HRV, heart rate variability; BDNF, brain-derived neurotropic factor; WASI, Wechsler Abbreviated Scale of Intelligence; WAIS-IV, Wechsler Adult Intelligence Scale – Fourth Edition; D-KEFS, Delis–Kaplan Executive Function System; TMT, Trail-Making Test; VF, Verbal Fluency; CWIT, Color Word Interference Test

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