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Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

The impact of an exercise training intervention on cortisol levels and post-traumatic stress disorder in juveniles from an Ugandan refugee settlement: study protocol for a randomized control trial

Authors: Henning Budde, Davin P. Akko, Herbert E. Ainamani, Eric Murillo-Rodríguez, Roland Weierstall

Published in: Trials | Issue 1/2018

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Abstract

Background

Latest research demonstrates a significant improvement in stress-related symptoms in psychological disorders as a result of exercise training (ET). Controlled clinical trials further validate the significance of ET by demonstrating lower salivary cortisol levels in patients with post-traumatic stress disorder (PTSD) after intervention. A significant change in cortisol and dehydroepiandrosterone (DHEA) levels can already be found after an 8–12-week ET program. The proposed study aims to investigate the impact of an 8-week ET on PTSD symptoms and changes in cortisol levels in a juvenile refugee sample from the Democratic Republic of the Congo (DRC) at an Ugandan refugee settlement. It is the first to implement an ET intervention in a resource-poor, post-conflict setting.

Methods/design

In a randomized controlled trial, 198 adolescent participants aged 13–16 years from the DRC who, suffer from PTSD, will be investigated. The participants are based at the Nakivale refugee settlement, an official refugee camp in Uganda, Africa, which is among the largest in the world. The participants will be randomized into an Exercise Training (ET) group with a maximum heart rate (HRmax) of > 60%, an Alternative Intervention (AI) group with low-level exercises, and a Waiting-list Control (WC) group. After the 8-week interventional phase, changes in cortisol awakening response (CAR) and DHEA in the ET group that correspond to an improvement in PTSD symptoms are expected that remain at follow-up after 3 months.

Discussion

To date, there is no controlled and reliable longitudinal study examining the effects of an ET program on symptom severity in individuals with PTSD that can be explained with a harmonization of cortisol secretion. The presented study design introduces an intervention that can be implemented with little expenditure. It aims to provide a promising low-threshold and cost-effective treatment approach for the application in resource-poor settings.

Trial registration

German Trials Register, ID: DRKS00014280. Registered prospectively on 15 March 2018.
Appendix
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Literature
1.
The UN Refugee Agency. UNHCR Statistical yearbook 2015; 2017. p. 15.
2.
Hollifield M, Warner TD, Lian N, Krakow B, Jenkins JH, Kesler J, Stevenson J, Westermeyer J. Measuring trauma and health status in refugees: a critical review. JAMA. 2002;288(5):611–21.CrossRefPubMed
3.
Onyut LP, Neuner F, Ertl V, Schauer E, Odenwald M, Elbert T. Trauma, poverty and mental health among Somali and Rwandese refugees living in an African refugee settlement—an epidemiological study. Confl Heal. 2009;3(1):6.CrossRef
4.
Amone-P’Olak K. Psychological impact of war and sexual abuse on adolescent girls in Northern Uganda. Intervention. 2005;3(1):33–45.
5.
Kakuma R, Minas H, van Ginneken N, Dal Poz MR, Desiraju K, Morris JE, Saxena S, Scheffler RM. Human resources for mental health care: current situation and strategies for action. Lancet. 2011;378(9803):1654–63.CrossRefPubMed
6.
Hensel-Dittmann D, Schauer M, Ruf M, Catani C, Odenwald M, Elbert T, Neuner F. Treatment of traumatized victims of war and torture: a randomized controlled comparison of narrative exposure therapy and stress inoculation training. Psychother Psychosom. 2011;80(6):345–52.CrossRefPubMed
7.
Foa EB, McLean CP, Yusko D. Therapy for posttraumatic stress and alcohol dependence—reply. JAMA. 2013;310(22):2458–9.CrossRefPubMed
8.
Schnyder U, Ehlers A, Elbert T, Foa EB, Gersons BP, Resick PA, Shapiro F, Cloitre M. Psychotherapies for PTSD: what do they have in common? Eur J Psychotraumatol. 2015;6:28186.CrossRefPubMed
9.
Hyman S, Chisholm D, Kessler R, Patel V, Whiteford H. Mental Disorders. In nd, DT Jamison, JG Breman, AR Measham, G Alleyne, M Claeson, DB Evans, P Jha, A Mills, P Musgrove (Eds.). Washington (DC): Disease Control Priorities in Developing Countries; 2006.
10.
11.
Budde H, Schwarz R, Velasques B, Ribeiro P, Holzweg M, Machado S, Brazaitis M, Staack F, Wegner M. The need for differentiating between exercise, physical activity, and training. Autoimmun Rev. 2016;15(1):110–1.CrossRefPubMed
12.
Rosenbaum S, Sherrington C, Tiedemann A. Exercise augmentation compared with usual care for post-traumatic stress disorder: a randomized controlled trial. Acta Psychiatr Scand. 2015;131(5):350–9.CrossRefPubMed
13.
Powers MB, Medina JL, Burns S, Kauffman BY, Monfils M, Asmundson GJG, Diamond A, McIntyre C, Smits JAJ. Exercise augmentation of exposure therapy for PTSD: rationale and pilot efficacy data. Cogn Behav Ther. 2015;44(4):314–27.CrossRefPubMedPubMedCentral
14.
Fetzner MG, Asmundson GJG. Aerobic exercise reduces symptoms of posttraumatic stress disorder: a randomized controlled trial. Cogn Behav Ther. 2015;44(4):301–13.CrossRefPubMed
15.
Rosenbaum S, Vancampfort D, Steel Z, Newby J, Ward PB, Stubbs B. Physical activity in the treatment of post-traumatic stress disorder: a systematic review and meta-analysis. Psychiatry Res. 2015;230(2):130–6.CrossRefPubMed
16.
Mitchell KS, Dick AM, DiMartino DM, Smith BN, Niles B, Koenen KC, Street A. A pilot study of a randomized controlled trial of yoga as an intervention for PTSD symptoms in women. J Trauma Stress. 2014;27(2):121–8.CrossRefPubMed
17.
Van Der Kolk BA, Stone L, West J, Rhodes A, Emerson D, Suvak M, Spinazzola J. Yoga as an adjunctive treatment for posttraumatic stress disorder: a randomized controlled trial. J Clin Psychiatry. 2014;75(6):1–7.CrossRef
18.
19.
Dickerson SS, Kemeny ME. Acute stressors and cortisol responses: a theoretical integration and synthesis of laboratory research. Psychol Bull. 2004;130(3):355–91.CrossRefPubMed
20.
Taylor MK. Dehydroepiandrosterone and dehydroepiandrosterone sulfate: anabolic, neuroprotective, and neuroexcitatory properties in military men. Mil Med. 2013;178(1):100–6.CrossRefPubMed
21.
Alberti KG, Johnston DG. Cortisol and catabolism: a new perspective. Clin Sci Mol Med. 1977;52(4):333–6.PubMed
22.
Karishma K, Herbert J. Dehydroepiandrosterone (DHEA) stimulates neurogenesis in the hippocampus of the rat, promotes survival of newly formed neurons and prevents corticosterone-induced suppression. Eur J Neurosci. 2002;16(3):445–53.CrossRefPubMed
23.
Raison CL, Miller AH. When not enough is too much: the role of insufficient glucocorticoid signaling in the pathophysiology of stress-related disorders. Am J Psychiatr. 2003;160(9):1554–65.CrossRefPubMed
24.
Maninger N, Wolkowitz OM, Reus VI, Epel ES, Mellon SH. Neurobiological and neuropsychiatric effects of dehydroepiandrosterone (DHEA) and DHEA sulfate (DHEAS). Front Neuroendocrinol. 2009;30(1):65–91.CrossRefPubMed
25.
Budde H, Voelcker-Rehage C, Pietrassyk-Kendziorra S, Machado S, Ribeiro P, Arafat AM. Steroid hormones in the saliva of adolescents after different exercise intensities and their influence on working memory in a school setting. Psychoneuroendocrinology. 2010;35(3):382–91.CrossRefPubMed
26.
Hill EE, Zack E, Battaglini C, Viru M, Viru A, Hackney AC. Exercise and circulating cortisol levels: the intensity threshold effect. J Endocrinol Investig. 2008;31(7):587–91.CrossRef
27.
Gouarne C, Groussard C, Gratas-Delamarche A, Delamarche P, Duclos M. Overnight urinary cortisol and cortisone add new insights into adaptation to training. Med Sci Sports Exerc. 2005;37(7):1157–67.CrossRefPubMed
28.
Minetto MA, Lanfranco F, Baldi M, Termine A, Kuipers H, Ghigo E, Rainoldi A. Corticotroph axis sensitivity after exercise: comparison between elite athletes and sedentary subjects. J Endocrinol Investig. 2007;30(3):215–23.CrossRef
29.
Skoluda N, Dettenborn L, Stalder T, Kirschbaum C. Elevated hair cortisol concentrations in endurance athletes. Psychoneuroendocrinology. 2012;37(5):611–7.CrossRefPubMed
30.
Klaperski S, von Dawans B, Heinrichs M, Fuchs R. Effects of a 12-week endurance training program on the physiological response to psychosocial stress in men: a randomized controlled trial. J Behav Med. 2014;37(6):1118–33.CrossRefPubMed
31.
Chen CY, Liao YH, Chou CC, Sung YC, Tsai SC. Initial systemic inflammatory state perturbs exercise training adaptations in elite Taekwondo athletes. PLoS One. 2017;12(4):e0176140.CrossRefPubMedPubMedCentral
32.
Hucklebridge F, Mellins J, Evans P, Clow A. The awakening cortisol response: no evidence for an influence of body posture. Life Sci. 2002;71(6):639–46.CrossRefPubMed
33.
Wust S, Wolf J, Hellhammer DH, Federenko I, Schommer N, Kirschbaum C. The cortisol awakening response—normal values and confounds. Noise Health. 2000;2(7):79.PubMed
34.
Chida Y, Steptoe A. Cortisol awakening response and psychosocial factors: a systematic review and meta-analysis. Biol Psychol. 2009;80(3):265–78.CrossRefPubMed
35.
Budde H, Pietrassyk-Kendziorra S, Bohm S, Voelcker-Rehage C. Hormonal responses to physical and cognitive stress in a school setting. Neurosci Lett. 2010;474(3):131–4.CrossRefPubMed
36.
Di Luigi L, Guidetti L, Baldari C, Gallotta MC, Sgro P, Perroni F, Romanelli F, Lenzi A. Cortisol, dehydroepiandrosterone sulphate and dehydroepiandrosterone sulphate/cortisol ratio responses to physical stress in males are influenced by pubertal development. J Endocrinol Investig. 2006;29(9):796–804.CrossRef
37.
Wingenfeld K, Whooley MA, Neylan TC, Otte C, Cohen BE. Effect of current and lifetime posttraumatic stress disorder on 24-h urinary catecholamines and cortisol: results from the Mind Your Heart Study. Psychoneuroendocrinology. 2015;52:83–91.CrossRefPubMed
38.
Meewisse ML, Reitsma JB, de Vries GJ, Gersons BP, Olff M. Cortisol and post-traumatic stress disorder in adults: systematic review and meta-analysis. Br J Psychiatry. 2007;191:387–92.CrossRefPubMed
39.
Mouthaan J, Sijbrandij M, Luitse JSK, Goslings JC, Gersons BPR, Olff M. The role of acute cortisol and DHEAS in predicting acute and chronic PTSD symptoms. Psychoneuroendocrinology. 2014;45:179–86.CrossRefPubMed
40.
Steudte S, Kirschbaum C, Gao W, Alexander N, Schönfeld S, Hoyer J, Stalder T. Hair cortisol as a biomarker of traumatization in healthy individuals and posttraumatic stress disorder patients. Biol Psychiatry. 2013;74(9):639–46.CrossRefPubMed
41.
Rauch SA, King AP, Abelson J, Tuerk PW, Smith E, Rothbaum BO, Clifton E, Defever A, Liberzon I. Biological and symptom changes in posttraumatic stress disorder treatment: a randomized clinical trial. Depress Anxiety. 2015;32(3):204–12.CrossRefPubMed
42.
Pervanidou P, Kolaitis G, Charitaki S, Lazaropoulou C, Papassotiriou I, Hindmarsh P, Bakoula C, Tsiantis J, Chrousos GP. The natural history of neuroendocrine changes in pediatric posttraumatic stress disorder (PTSD) after motor vehicle accidents: progressive divergence of noradrenaline and cortisol concentrations over time. Biol Psychiatry. 2007;62(10):1095–102.CrossRefPubMed
43.
Bicanic IA, Postma RM, Sinnema G, De Roos C, Olff M, Van Wesel F, Van de Putte EM. Salivary cortisol and dehydroepiandrosterone sulfate in adolescent rape victims with post traumatic stress disorder. Psychoneuroendocrinology. 2013;38(3):408–15.CrossRefPubMed
44.
Keeshin BR, Strawn JR, Out D, Granger DA, Putnam FW. Cortisol awakening response in adolescents with acute sexual abuse related posttraumatic stress disorder. Depress Anxiety. 2014;31(2):107–14.CrossRefPubMed
45.
Kim SH, Schneider SM, Bevans M, Kravitz L, Mermier C, Qualls C, Burge MR. PTSD symptom reduction with mindfulness-based stretching and deep breathing exercise: randomized controlled clinical trial of efficacy. J Clin Endocrinol Metab. 2013;98(7):2984–92.CrossRefPubMedPubMedCentral
46.
Ainamani HE, Elbert T, Olema DK, Hecker T. PTSD symptom severity relates to cognitive and psycho-social dysfunctioning—a study with Congolese refugees in Uganda. Eur J Psychotraumatol. 2017;8(1):1283086.CrossRefPubMedPubMedCentral
47.
Faul F, Erdfelder E, Lang A-G, Buchner A. G* Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007;39(2):175–91.CrossRefPubMed
48.
Neuner F, Onyut PL, Ertl V, Odenwald M, Schauer E, Elbert T. Treatment of posttraumatic stress disorder by trained lay counselors in an African refugee settlement: a randomized controlled trial. J Consult Clin Psychol. 2008;76(4):686–94.CrossRefPubMed
49.
Koutsandreou F, Wegner M, Niemann C, Budde H. Effects of motor versus cardiovascular exercise training on children’s working memory. Med Sci Sports Exerc. 2016;48(6):1144–52.CrossRefPubMed
50.
Deng G, Chan Y, Sjoberg D, Vickers A, Yeung KS, Kris M, Straus D, Cassileth B. Acupuncture for the treatment of post-chemotherapy chronic fatigue: a randomized, blinded, sham-controlled trial. Support Care Cancer. 2013;21(6):1735–41.CrossRefPubMedPubMedCentral
51.
Plag J, Gaudlitz K, Schumacher S, Dimeo F, Bobbert T, Kirschbaum C, Ströhle A. Effect of combined cognitive-behavioural therapy and endurance training on cortisol and salivary alpha-amylase in panic disorder. J Psychiatr Res. 2014;58:12–9.CrossRefPubMed
52.
Steinberg AM, Brymer MJ, Decker KB, Pynoos RS. The University of California at Los Angeles post-traumatic stress disorder reaction index. Curr Psychiatry Rep. 2004;6(2):96–100.CrossRefPubMed
53.
Sheehan D, Lecrubier Y, Sheehan KH, Janavs J, Weiller E, Keskiner A, Schinka J, Knapp E, Sheehan M, Dunbar G. The validity of the Mini International Neuropsychiatric Interview (MINI) according to the SCID-P and its reliability. Eur Psychiatry. 1997;12(5):232–41.CrossRef
54.
Pynoos R, Weathers F, Steinberg A, Marx B, Layne C, Kaloupek D, Kriegler J. Clinician-administered PTSD scale for DSM-5—child/adolescent version. Scale available from the National Center for PTSD at www ptsd va gov 2015.
55.
Preston JM. “If they abduct you, you don’t come back”: Understanding Ugandan former child soldiers in the context of their life. Peace Conflict. 2015;21(3):432.CrossRef
56.
Gilbody S, Richards D, Brealey S, Hewitt C. Screening for depression in medical settings with the Patient Health Questionnaire (PQ): a diagnostic meta-analysis. J Gen Intern Med. 2007;22(11):1596–602.CrossRefPubMedPubMedCentral
57.
Goodman R. The Strengths and Difficulties Questionnaire: a research note. J Child Psychol Psychiatry. 1997;38(5):581–6.CrossRefPubMed
58.
Ashworth M, Shepherd M, Christey J, Matthews V, Wright K, Parmentier H, Robinson S, Godfrey E. A client-generated psychometric instrument: The development of ‘PSYCHLOPS. Couns Psychother Res. 2004;4(2):27–31.CrossRef
59.
Johansson I, Saelbtröm A-K, Rajan B, Parameswaran A. Salivary flow and dental caries in Indian children suffering from chronic malnutrition. Caries Res. 1992;26(1):38–43.CrossRefPubMed
60.
Craig CL, Marshall AL, Sjöström M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF. International Physical Activity Questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003;35(8):1381–95.CrossRefPubMed
61.
Oyeyemi AL, Oyeyemi AY, Adegoke BO, Oyetoke FO, Aliyu HN, Aliyu SU, Rufai AA. The Short International Physical Activity Questionnaire: cross-cultural adaptation, validation and reliability of the Hausa language version in Nigeria. BMC Med Res Methodol. 2011;11(1):156.CrossRefPubMedPubMedCentral
62.
Quetelet A. Recherches sur le poids de l’homme aux different ages. Nouveaux Memoire de l’Académie Royale des Sciences et Belles-Lettres de Bruxelles. 1832;7:1–83.
63.
Vythilingam M, Gill JM, Luckenbaugh DA, Gold PW, Collin C, Bonne O, Plumb K, Polignano E, West K, Charney D. Low early morning plasma cortisol in posttraumatic stress disorder is associated with co-morbid depression but not with enhanced glucocorticoid feedback inhibition. Psychoneuroendocrinology. 2010;35(3):442–50.CrossRefPubMed
64.
Weierstall R, Schalinski I, Crombach A, Hecker T, Elbert T. When combat prevents PTSD symptoms—Results from a survey with former child soldiers in Northern Uganda. BMC Psychiatry. 2012;12(1):41.CrossRefPubMedPubMedCentral
Metadata
Title
The impact of an exercise training intervention on cortisol levels and post-traumatic stress disorder in juveniles from an Ugandan refugee settlement: study protocol for a randomized control trial
Authors
Henning Budde
Davin P. Akko
Herbert E. Ainamani
Eric Murillo-Rodríguez
Roland Weierstall
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2753-x

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