Physical exercise augmented cognitive behaviour therapy for older adults with generalised anxiety disorder (PEXACOG): study protocol for a randomized controlled trial.
Brain-derived neurotrophic factor
CBT
Cognitive behavioural therapy
Executive function
GAD
Generalised anxiety disorder
Older adults
Physical exercise
RCT
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
18 Mar 2019
18 Mar 2019
Historique:
received:
25
06
2018
accepted:
28
02
2019
entrez:
20
3
2019
pubmed:
20
3
2019
medline:
6
8
2019
Statut:
epublish
Résumé
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.
Sections du résumé
BACKGROUND
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
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
CONCLUSIONS
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
BACKGROUND
ClinicalTrials.gov, NCT02690441 . Registered on 24 February 2016.
Identifiants
pubmed: 30885256
doi: 10.1186/s13063-019-3268-9
pii: 10.1186/s13063-019-3268-9
pmc: PMC6423789
doi:
Banques de données
ClinicalTrials.gov
['NCT02690441']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Pagination
174Commentaires et corrections
Type : ErratumIn
Références
J Psychiatr Res. 1975 Nov;12(3):189-98
pubmed: 1202204
Transl Psychiatry. 2015 Mar 31;5:e536
pubmed: 25826111
Am J Geriatr Psychiatry. 2005 Jan;13(1):23-30
pubmed: 15653937
Neurosci Biobehav Rev. 2013 Nov;37(9 Pt B):2243-57
pubmed: 23623982
Clin Psychol Rev. 2017 Mar;52:124-136
pubmed: 28119196
J Consult Clin Psychol. 2003 Feb;71(1):31-40
pubmed: 12602423
Neuroimage. 2009 Jan 1;44(1):213-22
pubmed: 18778779
Dialogues Clin Neurosci. 2015 Sep;17(3):327-35
pubmed: 26487813
Arch Intern Med. 2006 May 22;166(10):1092-7
pubmed: 16717171
Scand J Med Sci Sports. 2014 Apr;24(2):319-26
pubmed: 23126417
J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57
pubmed: 9881538
Am J Geriatr Psychiatry. 2009 Jun;17(6):455-64
pubmed: 19472431
J Clin Psychiatry. 2011 Jan;72(1):43-50
pubmed: 20816036
J Gerontol A Biol Sci Med Sci. 2003 Feb;58(2):176-80
pubmed: 12586857
Behav Res Ther. 1990;28(6):487-95
pubmed: 2076086
Int J Cardiol. 2010 May 28;141(2):122-31
pubmed: 19910061
Psychosom Med. 2010 Apr;72(3):239-52
pubmed: 20223924
Eur J Neurosci. 2008 Dec;28(11):2278-87
pubmed: 19046371
J Psychiatr Res. 2018 Jun;101:34-41
pubmed: 29539585
Methods Mol Biol. 2009;578:293-306
pubmed: 19768602
Health Psychol. 2010 Mar;29(2):130-3
pubmed: 20230085
Eur Heart J. 1996 Mar;17(3):354-81
pubmed: 8737210
Am J Geriatr Psychiatry. 2003 Jan-Feb;11(1):24-32
pubmed: 12527537
J Gerontol. 1991 May;46(3):M99-106
pubmed: 2030273
Arch Gen Psychiatry. 2005 Jun;62(6):617-27
pubmed: 15939839
Cogn Behav Ther. 2015;44(4):275-87
pubmed: 25785484
Int J Psychophysiol. 2010 Jun;76(3):123-9
pubmed: 20193717
Int J Psychophysiol. 2012 Dec;86(3):269-75
pubmed: 23069273
Biol Psychiatry. 2006 Jun 15;59(12):1116-27
pubmed: 16631126
J Gerontol A Biol Sci Med Sci. 2006 Nov;61(11):1166-70
pubmed: 17167157
J Anxiety Disord. 2013 Aug;27(6):567-75
pubmed: 23298889
Biol Psychiatry. 2013 Jun 1;73(11):1059-63
pubmed: 23312562
Arch Gen Psychiatry. 2010 May;67(5):489-96
pubmed: 20439830
J Am Geriatr Soc. 2012 Feb;60(2):218-29
pubmed: 22283717
Am J Cardiol. 1998 Nov 15;82(10):1236-41
pubmed: 9832101
Physiol Behav. 2011 Oct 24;104(5):934-41
pubmed: 21722657
Med Sci Sports Exerc. 2003 Aug;35(8):1381-95
pubmed: 12900694
J Psychiatr Res. 2015 Jan;60:56-64
pubmed: 25455510
Sports Med. 2003;33(12):889-919
pubmed: 12974657
Prog Neuropsychopharmacol Biol Psychiatry. 2005 Jun;29(5):658-63
pubmed: 15905010
J Anxiety Disord. 2008 Aug;22(6):959-68
pubmed: 17988832
Psychoneuroendocrinology. 2014 Jan;39:214-224
pubmed: 24149089
Hippocampus. 2009 Oct;19(10):1030-9
pubmed: 19123237
Proc Natl Acad Sci U S A. 2004 Mar 2;101(9):3316-21
pubmed: 14978288
Int J Neuropsychopharmacol. 2016 Feb 12;19(6):
pubmed: 26874331
J Consult Clin Psychol. 1993 Aug;61(4):611-9
pubmed: 8370856
Am J Psychiatry. 2013 Jul;170(7):782-9
pubmed: 23680817
Int J Psychophysiol. 2013 Jan;87(1):19-27
pubmed: 23107994
J Anxiety Disord. 2013 Aug;27(6):576-84
pubmed: 23253357
Arch Gen Psychiatry. 2005 Jun;62(6):593-602
pubmed: 15939837
Gerontology. 2011;57(6):502-12
pubmed: 21860214
Neuropsychobiology. 1997;36(4):182-7
pubmed: 9396017
BMC Med Res Methodol. 2008 Oct 09;8:63
pubmed: 18844976
Cognit Ther Res. 2012 Oct 1;36(5):427-440
pubmed: 23459093
Behav Res Methods. 2007 May;39(2):175-91
pubmed: 17695343
Sleep Med Rev. 2011 Aug;15(4):259-67
pubmed: 21237680
Int J Geriatr Psychiatry. 1998 Oct;13(10):717-26
pubmed: 9818308
Percept Mot Skills. 2008 Dec;107(3):691-706
pubmed: 19235401
Depress Anxiety. 2015 Mar;32(3):221-8
pubmed: 25515221
Nat Rev Neurosci. 2008 Jan;9(1):58-65
pubmed: 18094706
Psychoneuroendocrinology. 2010 Apr;35(3):364-8
pubmed: 19682803
Eur J Appl Physiol. 2010 Jul;109(4):617-24
pubmed: 20186426
J Anxiety Disord. 2017 Aug;50:76-86
pubmed: 28618306
Depress Anxiety. 2002;16(4):162-71
pubmed: 12497648
Behav Res Ther. 2005 Apr;43(4):447-65
pubmed: 15701356
Emotion. 2007 May;7(2):336-53
pubmed: 17516812
Ann Intern Med. 2007 Mar 6;146(5):317-25
pubmed: 17339617
Hum Brain Mapp. 2001 Nov;14(3):140-51
pubmed: 11559959
Eur J Appl Physiol. 2004 Dec;93(3):263-72
pubmed: 15338220
Am J Psychiatry. 2000 May;157(5):669-82
pubmed: 10784456
Int Psychogeriatr. 2007 Feb;19(1):103-14
pubmed: 16805925
Acta Psychiatr Scand Suppl. 2000;(406):14-23
pubmed: 11131466