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

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...

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Main Authors: 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
Format: Article
Language:English
Published: BMC 2019-03-01
Series:Trials
Subjects:
Online Access:http://link.springer.com/article/10.1186/s13063-019-3268-9
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author 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
author_facet 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
author_sort Silje Haukenes Stavestrand
collection DOAJ
description 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.
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spelling doaj.art-0d43fe2705a344c7844bb05bab506e7d2022-12-22T01:14:37ZengBMCTrials1745-62152019-03-0120111410.1186/s13063-019-3268-9Physical exercise augmented cognitive behaviour therapy for older adults with generalised anxiety disorder (PEXACOG): study protocol for a randomized controlled trialSilje Haukenes Stavestrand0Kristine Sirevåg1Inger Hilde Nordhus2Trond Sjøbø3Trygve Bruun Endal4Hans M. Nordahl5Karsten Specht6Åsa Hammar7Anne Halmøy8Egil W. Martinsen9Eva Andersson10Helene Hjelmervik11Jan Mohlman12Julian F. Thayer13Anders Hovland14Faculty of Psychology, University of BergenFaculty of Psychology, University of BergenFaculty of Psychology, University of BergenSolli DPSSolli DPSDepartment of Mental Health, Norwegian University of Science and TechnologyFaculty of Psychology, University of BergenFaculty of Psychology, University of BergenFaculty of Medicine, K.G. Jebsen Centre for Neuropsychiatric Disorders, University of BergenFaculty of Medicine, University of OsloThe Swedish School of Sport and Health Sciences, GIHFaculty of Psychology, University of BergenDepartment of Psychology, William Paterson UniversityDepartment of Psychology, Ohio State UniversityFaculty of Psychology, University of BergenAbstract 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.http://link.springer.com/article/10.1186/s13063-019-3268-9Generalised anxiety disorderGADOlder adultsPhysical exerciseCognitive behavioural therapyCBT
spellingShingle 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
Physical exercise augmented cognitive behaviour therapy for older adults with generalised anxiety disorder (PEXACOG): study protocol for a randomized controlled trial
Trials
Generalised anxiety disorder
GAD
Older adults
Physical exercise
Cognitive behavioural therapy
CBT
title Physical exercise augmented cognitive behaviour therapy for older adults with generalised anxiety disorder (PEXACOG): study protocol for a randomized controlled trial
title_full Physical exercise augmented cognitive behaviour therapy for older adults with generalised anxiety disorder (PEXACOG): study protocol for a randomized controlled trial
title_fullStr Physical exercise augmented cognitive behaviour therapy for older adults with generalised anxiety disorder (PEXACOG): study protocol for a randomized controlled trial
title_full_unstemmed Physical exercise augmented cognitive behaviour therapy for older adults with generalised anxiety disorder (PEXACOG): study protocol for a randomized controlled trial
title_short Physical exercise augmented cognitive behaviour therapy for older adults with generalised anxiety disorder (PEXACOG): study protocol for a randomized controlled trial
title_sort physical exercise augmented cognitive behaviour therapy for older adults with generalised anxiety disorder pexacog study protocol for a randomized controlled trial
topic Generalised anxiety disorder
GAD
Older adults
Physical exercise
Cognitive behavioural therapy
CBT
url http://link.springer.com/article/10.1186/s13063-019-3268-9
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