Clinical trial NCT06390618: Biopsychosocial Effectiveness of Exercise Trainings in Earthquake Survivors With Post-Traumatic Stress Disorder
Official title: Investigation of the Biopsychosocial Effectiveness of Different Exercise Trainings in Earthquake Survivors With Post-Traumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Post-Traumatic Stress Disorder
Keywords: Post-Traumatic Stress Disorder
Aerobic Exercise
Biopsychosocial Models
Qualitative and Quantitative Evaluation
Physical therapy
Lead sponsor: Hasan Kalyoncu University
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: According to randomization, they will be divided into 3 groups: aerobic exercise group (AE), combined exercise (CE) group in which biopsychosocial exercise is performed in addition to aerobic exercise, and control group (C).
Primary purpose: TREATMENT

Brief summary: In study, the investigators aim to demonstrate the effectiveness of biopsychosocial-based exercise approach in post-traumatic stress disorder of physiotherapists in post-earthquake disaster management.

Detailed description: The aim of this study is to compare the effects of aerobic exercise and biopsychosocial exercise in addition to aerobic exercise on functional capacity, trauma symptoms, depression, anxiety, stress, sleep quality, quality of life and biopsychosocial status in earthquake victims with post-traumatic stress disorder (PTSD).

Individuals will be randomized using the covariate adaptive randomization method. According to this randomization, they will be divided into 3 groups: aerobic exercise group (AE), combined exercise (CE) group, in which biopsychosocial exercise is performed in addition to aerobic exercise, and control group (C).

A total of 16 sessions of treatment will be performed in 8 weeks, 2 days a week. In the control group, no intervention will be made. The change over time in the control group and individuals with post-traumatic stress disorder will be monitored.

Questionnaires for quantitative data before treatment and 8 weeks after treatment; Data will also be collected through interview questions for qualitative data about experience/change after 8 weeks of treatment. In our study, mixed methods research will be used because it is thought that the survey data can be more descriptive and meaningful by supporting qualitative interview questions. Explanatory sequential mixed methods type will be used as a mixed methods research design. According to this design, quantitative data will be collected first and then qualitative data about the topic to be focused on will be collected from group interviews with semi-structured interview questions. Phenomenology research focuses on the experiences of participants. Phenomenological research method will be used in qualitative research.

A moderate intensity (50-60%) aerobic exercise program will be applied 3 days a week, using the karvonen method for aerobic exercise. According to the aerobic exercise intensity karvonen method, the formula "(Maximal Heart Rate (220-years) - Resting Heart Rate) x 50-60% + Resting Heart Rate)" will be used. 1-4. week 50%, 5-8. Exercise intensity will be increased by 60% per week.

Cognitive Exercise Therapy Approach (BETY) will be applied as a biopsychosocial exercise. BETY method is a patient-centered biopsychosocial approach and a holistic treatment option. On the basis of the BETY session, warm-up movements, exercises and cooling movements will be performed sequentially. While authentic movements are performed accompanied by music as dance therapy during the warm-up and cool-down period, functional trunk stabilization exercises are used during the exercises period. In addition, cognitive change is aimed by expressing positive and negative emotions during side lying exercises. Social support will also be provided by holding BETY sessions as a group. Thus, the aim is biological recovery with exercises, psychological recovery by expressing negative-positive thoughts during exercises and emphasizing staying in positive thoughts, and social recovery with group treatment.

After the data are collected, a randomized controlled double-blind study will be conducted by ensuring the blindness of the evaluator and the statistician. Blinding will be achieved by assigning numbers to randomized patients and keeping the evaluator and statistician from knowing which patient is in which group. To calculate the sample size, power analysis will be made by referring to similar studies.

Eligibility criteria: Inclusion Criteria:

* Individuals diagnosed with earthquake-related post-traumatic stress disorder (PTSD)
* 18-65 years old
* Individuals who agree to participate in the study voluntarily

Exclusion Criteria:

* Individuals with another psychiatric diagnosis
* Individuals with a body mass index of more than 35 kg/m2
* Individuals with a history of another trauma
* Pregnant women
* Individuals with neurological findings
* Individuals with malignancy, rheumatological, metabolic bone disease
* Individuals with a history of columna vertebralis and lower extremity surgery
* Individuals with severe osteoporosis
* Individuals who are illiterate and have communication problems
* Individuals with hearing problems
* Individuals who do not attend treatment regularly
* Individuals continuing another physiotherapy program

Primary outcomes:
measure: Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire (BETY-BQ)
timeFrame: eight weeks
measure: Qualitative Interview Questions (from group interviews with semi-structured interview questions)
timeFrame: eight weeks
Secondary outcomes:
measure: 6 Minute Walking Test
timeFrame: eight weeks
measure: Post-Traumatic Stress Disorder (PTSD) Checklist (PCL-5)
timeFrame: eight weeks
measure: Post-Traumatic Stress Diagnostic Scale (PTSDS)
timeFrame: eight weeks
measure: Impact of Events Scale-Revised (IES-R)
timeFrame: eight weeks
measure: Depression Anxiety and Stress Scale (DASS-21)
timeFrame: eight weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: eight weeks
measure: SF-36 Short Form
timeFrame: eight weeks
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Hasan Kalyoncu University
Study officials:
References:
citation: Adhikari SP, Bimali I, Baidya S, Shakya NR. Community-based rehabilitation for physically impaired earthquake victims: An evidence-based practice protocol and its pre-post experimental study. J Family Med Prim Care. 2018 Nov-Dec;7(6):1327-1333. doi: 10.4103/jfmpc.jfmpc_112_18.
citation: Ahmed SK, Dhama K, Abdulqadir SO, Omar RM, Ahmed DR, Chakraborty C, Saied AA. The mental health of people in Turkey-Syria earthquake-affected areas needs urgent attention. Asian J Psychiatr. 2023 Jun;84:103573. doi: 10.1016/j.ajp.2023.103573. Epub 2023 Mar 28. No abstract available.
citation: Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
citation: Gibbons WJ, Fruchter N, Sloan S, Levy RD. Reference values for a multiple repetition 6-minute walk test in healthy adults older than 20 years. J Cardiopulm Rehabil. 2001 Mar-Apr;21(2):87-93. doi: 10.1097/00008483-200103000-00005.
citation: Horowitz M, Wilner N, Alvarez W. Impact of Event Scale: a measure of subjective stress. Psychosom Med. 1979 May;41(3):209-18. doi: 10.1097/00006842-197905000-00004.
citation: Kukihara H, Yamawaki N, Uchiyama K, Arai S, Horikawa E. Trauma, depression, and resilience of earthquake/tsunami/nuclear disaster survivors of Hirono, Fukushima, Japan. Psychiatry Clin Neurosci. 2014 Jul;68(7):524-33. doi: 10.1111/pcn.12159. Epub 2014 Mar 4.
citation: Kuroda Y, Iwasa H, Orui M, Moriyama N, Suemoto CK, Yashiro C, Matsuda K, Yasumura S. Risk Factor for Incident Functional Disability and the Effect of a Preventive Exercise Program: A 4-Year Prospective Cohort Study of Older Survivors from the Great East Japan Earthquake and Nuclear Disaster. Int J Environ Res Public Health. 2018 Jul 6;15(7):1430. doi: 10.3390/ijerph15071430.
citation: Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.
citation: Manger TA, Motta RW. The impact of an exercise program on posttraumatic stress disorder, anxiety, and depression. Int J Emerg Ment Health. 2005 Winter;7(1):49-57.
citation: Momma H, Niu K, Kobayashi Y, Huang C, Otomo A, Chujo M, Tadaura H, Nagatomi R. Leg extension power is a pre-disaster modifiable risk factor for post-traumatic stress disorder among survivors of the Great East Japan Earthquake: a retrospective cohort study. PLoS One. 2014 Apr 23;9(4):e96131. doi: 10.1371/journal.pone.0096131. eCollection 2014.
citation: Thordardottir K, Gudmundsdottir R, Zoega H, Valdimarsdottir UA, Gudmundsdottir B. Effects of yoga practice on stress-related symptoms in the aftermath of an earthquake: A community-based controlled trial. Complement Ther Med. 2014 Apr;22(2):226-34. doi: 10.1016/j.ctim.2014.01.008. Epub 2014 Feb 2.
citation: Tian Y, Wong TK, Li J, Jiang X. Posttraumatic stress disorder and its risk factors among adolescent survivors three years after an 8.0 magnitude earthquake in China. BMC Public Health. 2014 Oct 15;14:1073. doi: 10.1186/1471-2458-14-1073.
citation: Tsuji T, Sasaki Y, Matsuyama Y, Sato Y, Aida J, Kondo K, Kawachi I. Reducing depressive symptoms after the Great East Japan Earthquake in older survivors through group exercise participation and regular walking: a prospective observational study. BMJ Open. 2017 Mar 3;7(3):e013706. doi: 10.1136/bmjopen-2016-013706.
citation: Zahid M, Unal E, Ozdemir Isik O, Oksuz S, Karakaya J, Erguney Cefle A. The reliability, validity, and responsiveness of Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire for patients with fibromyalgia. Int J Rheum Dis. 2022 Jun;25(6):685-691. doi: 10.1111/1756-185X.14325. Epub 2022 May 3.