Internet-based Physical Activities Randomized Controlled Trial in Mild/Moderate Depression Participants: SONRIE Project
NCT ID: NCT05849792
Last Updated: 2023-05-09
Study Results
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Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2019-09-01
2020-10-30
Brief Summary
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1. \- To determine the association of physical activity levels, sedentary behavior, sleep patterns, physical condition, diet, and general health status with mental and social well-being, and quality of life in a large sample of adult patients diagnosed with mild or moderate depression.
2. \- To examine the predictive capacity of physical activity, sedentary behaviors, and physical condition on mild and moderate depressive disorder.
3. \- To study the effect of a period without an intervention program with physical activity (8 weeks without exercise intervention) on the variables studied.
4. \- To examine the role of the endocannabinoid system on depression as well as its behavior after an intervention program of physical activity.
Participants will be involved in a physical activity intervention program for 12 weeks.
Researchers will compare intervention group and control group to see if an intervention program with physical activity for 12 weeks improve depression, social and emotional well-being and quality of life and health in adults with mild and moderate depression.
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Detailed Description
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Sample size and statistical power
Sample size determination will be estimated with a 5% type I error (α) and 95% confidence interval establishing a level of precision (d = 0.095) for the hypothesis test to comparing two proportions. The desired sample size will be n = 96 participants and it will be increased by 10% (n = 106) to compensate the possible dropout of participants during the evaluation process of the study. Sample size for the hypothesis test to comparing two means for the intervention study will consider with a significance level alpha of 0.05 and a power of 0.95 (beta = 0.05) and considering the standard deviation for depression variable as 9.36 (Bouldering psychotherapy reduces depressive symptoms even when general physical activity is controlled for: A randomized controlled trial, Heylon, 2018; Mar; 4 (3): e00580). In this way, to detect a minimum mean difference of 8.26 between control and experimental groups for the depression variable, it is estimated that the sample size of each group should be 30 patients. Therefore, a total of 60 participants will be randomly recruited to each group balanced by sex, age and depression clinical severity. It should be taking into account that several simulations to estimate the sample size based on previous studies were performed by STATA statistical software vs. 14.0.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Exercise group
Group where the participants realize an intervention based on exercise and psychology.
Exercise and psychological intervention
Physical Exercise Intervention
Sixty-minute sessions were delivered via internet, three times per week (1 supervised) over the first four weeks of the COVID-19 home confinement. The intervention was a multicomponent exercise program lead by a specialist in fitness composed of aerobic, resistance, balance, coordination, mobility and stretching exercises. Each multicomponent exercise session consisted of a 10 min warm-up, 40 min of moderate to vigorous intensity physical activity, and 10 min cool down.
Psychological intervention
The internet-based-psychological intervention provided to different component of Cognitive Behavioral Therapy (CBT) guided and recorded by a sport neuro-psychologist specialist. The iCBT is based on the protocol for face-to-face CBT for depression. The program consisted of 4 weeks composed of 2 weekly video-guided sessions, with a maximum duration of 30 minutes. iCBT was focused on 4 main axes of action physiological, emotional, behavioral and cognitive.
Control
Group where the subjects do not realize the intervention.
No interventions assigned to this group
Interventions
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Exercise and psychological intervention
Physical Exercise Intervention
Sixty-minute sessions were delivered via internet, three times per week (1 supervised) over the first four weeks of the COVID-19 home confinement. The intervention was a multicomponent exercise program lead by a specialist in fitness composed of aerobic, resistance, balance, coordination, mobility and stretching exercises. Each multicomponent exercise session consisted of a 10 min warm-up, 40 min of moderate to vigorous intensity physical activity, and 10 min cool down.
Psychological intervention
The internet-based-psychological intervention provided to different component of Cognitive Behavioral Therapy (CBT) guided and recorded by a sport neuro-psychologist specialist. The iCBT is based on the protocol for face-to-face CBT for depression. The program consisted of 4 weeks composed of 2 weekly video-guided sessions, with a maximum duration of 30 minutes. iCBT was focused on 4 main axes of action physiological, emotional, behavioral and cognitive.
Eligibility Criteria
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Inclusion Criteria
* Mild and / or moderate depression diagnosed by Beck Scale.
* Do not have other severe somatic or psychiatric disorders or other diseases that prevents physical activity.
* To be able to communicate with any problem.
* To be able to read and understand the main purpose of the study.
* Informed consent: must be capable and willing to provide consent.
Exclusion Criteria
* Acute or terminal illness.
* History of cerebral infarction, epilepsy, brain tumor.
* Unstable cardiovascular disease, or other medical conditions.
* Upper or lower extremity fracture in the past 3 months.
* Severe visual or auditory problems.
* Unwillingness to either complete the study requirements or to be randomized into control or training group.
* To be a participant in another research study that may influence the present project.
25 Years
65 Years
ALL
No
Sponsors
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Junta de Andalucia
OTHER_GOV
Institute of Biomedical research and innovation of Cádiz (INIBICA)
UNKNOWN
University of Cadiz
OTHER
Responsible Party
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Locations
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University of Cádiz
Puerto Real, Cádiz, Spain
Countries
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References
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Richter P, Werner J, Heerlein A, Kraus A, Sauer H. On the validity of the Beck Depression Inventory. A review. Psychopathology. 1998;31(3):160-8. doi: 10.1159/000066239.
BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.
Spielberger CD, Gorsuch RL, L. R. State-trait anxiety inventory. Palo Alto Consult. Psychol. Press 1-23 (1970)
Ryff, C. D. Happiness is everything, or is it? Explorations on the meaning of psychological well-being. J. Pers. Soc. Psychol. 57, 1069-1081 (1989)
Diaz D, Rodriguez-Carvajal R, Blanco A, Moreno-Jimenez B, Gallardo I, Valle C, van Dierendonck D. [Spanish adaptation of the Psychological Well-Being Scales (PWBS)]. Psicothema. 2006 Aug;18(3):572-7. Spanish.
Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
Vilagut G, Ferrer M, Rajmil L, Rebollo P, Permanyer-Miralda G, Quintana JM, Santed R, Valderas JM, Ribera A, Domingo-Salvany A, Alonso J. [The Spanish version of the Short Form 36 Health Survey: a decade of experience and new developments]. Gac Sanit. 2005 Mar-Apr;19(2):135-50. doi: 10.1157/13074369. Spanish.
Pietrobelli A, Rubiano F, St-Onge MP, Heymsfield SB. New bioimpedance analysis system: improved phenotyping with whole-body analysis. Eur J Clin Nutr. 2004 Nov;58(11):1479-84. doi: 10.1038/sj.ejcn.1601993.
Di Marzo V, Matias I. Endocannabinoid control of food intake and energy balance. Nat Neurosci. 2005 May;8(5):585-9. doi: 10.1038/nn1457.
Kroes R, Muller D, Lambe J, Lowik MR, van Klaveren J, Kleiner J, Massey R, Mayer S, Urieta I, Verger P, Visconti A. Assessment of intake from the diet. Food Chem Toxicol. 2002 Feb-Mar;40(2-3):327-85. doi: 10.1016/s0278-6915(01)00113-2.
Martinez-Gonzalez MA, Fernandez-Jarne E, Serrano-Martinez M, Wright M, Gomez-Gracia E. Development of a short dietary intake questionnaire for the quantitative estimation of adherence to a cardioprotective Mediterranean diet. Eur J Clin Nutr. 2004 Nov;58(11):1550-2. doi: 10.1038/sj.ejcn.1602004.
Gonzalez Carrascosa R, Bayo Monto JL, Meneu Barreira T, Garcia Segovia P, Martinez-Monzo J. Design of a self-administered online food frequency questionnaire (FFQ) to assess dietary intake among university population. Nutr Hosp. 2011 Nov-Dec;26(6):1440-6. doi: 10.1590/S0212-16112011000600035.
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.
Other Identifiers
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PI/0068/2018
Identifier Type: -
Identifier Source: org_study_id
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