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This clinical trial assesses the effect of a telecare psychosocial intervention designed for adults with spina bifida. The intervention consists of 10 weekly 1.5-hour group sessions, followed by two 3-month follow-up sessions. Each group will consist of 6 to 7 individuals. The intervention is aimed at strengthening aspects of self-concept, self-esteem, social skills and aims at a reduction of symptomatology and a general improvement of psychological well-being.
The present study undertakes the development and evaluation of a structured, psychosocial teleassistance intervention designed for adult individuals with spina bifida. The variables of interest and intervention include quality of life, self-esteem, self-concept, anxious-depressive symptomatology, interpersonal needs and coping strategies. The study aims to test whether the psychosocial teleassistance programme improves the aforementioned variables.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psychosocial teleassistance intervention | Experimental | Psychosocial intervention, comprising 10 group sessions, followed by two 3-month follow-up sessions, is offered. |
|
| Wait list | Experimental | Waiting list control group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychosocial teleassistance intervention | Behavioral | The teleassistance psychosocial intervention involves 10 weekly 90-minute group sessions, with each group comprising 6 to 7 participants. These sessions are designed to enhance self-concept, self-esteem and social skills, reduce symptoms, and improve overall psychological well-being. Two follow-up sessions will be provided three months after the main program concludes. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life - The World Health Organization WHOQOL-BREF Quality of Life Assessment | The World Health Organization WHOQOL-BREF Quality of Life Assessment (WHOQOL-BREF) is a tool designed to assess quality of life using twenty-six items. The questionnaire measures four different domains: physical health, psychological health, social relationships, and environment. Domain scores are transformed to a scale ranging from 0 to 100. Higher scores reflect better quality of life. | 3 months after the intervention |
| Anxiety and depression - The Hospital Anxiety and Depression Scale | The Hospital Anxiety and Depression Scale (HADS) is a scale primarily designed to assess anxiety and depressive symptomatology using 14 items. The instrument is composed of two subscales: an anxiety subscale and a depression subscale. Total scores on each subscale range from 0 to 21, where a higher score is indicative of greater symptom severity. | 3 months after the intervention |
| Depression - The Patient Health Questionnaire | The Patient Health Questionnaire (PHQ-9) is a brief, nine-item tool designed to detect and measure the severity of depression. The score can range from 0 to 27. Higher scores reflect more severe depressive symptoms, whereas lower scores indicate minimal or no depressive symptoms. | 3 months after the intervention |
| Self-esteem - The Rosenberg Self-Esteem Scale | The Rosenberg Self-Esteem Scale (RSE) is a 10-item scale designed to assess self-esteem. The final score ranges from 10 to 40. Higher scores reflect greater self-esteem, whereas lower scores indicate reduced self-esteem. | 3 months after the intervention |
| Self-Concept - Self-Concept Questionnaire Form-5 | The Self-Concept Questionnaire Form-5 (AF-5) is an instrument used to evaluate self-concept across five dimensions: social, academic-work/professional, emotional, family, and physical. Domain scores are transformed to a scale ranging from 0 to 10. Higher scores indicate a better self-concept across domains, while lower scores reflect worse self-concept in those areas. |
| Measure | Description | Time Frame |
|---|---|---|
| Functionality - The Barthel Index | The Barthel Index (IB) is an instrument used to evaluate physical functionality and level of independence across ten basic activities of daily living. Scores range from 0 to 100. A higher score reflects better functional independence, whereas a lower score indicates greater dependence for daily activities. | 3 months after the intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Óscar Martínez, PhD | Contact | + 34 944 139 113 | 2687 | oscar.martinez@deusto.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Deusto | Recruiting | Bilbao | Bizkaia | 48007 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Ordoñez-Carrasco, J. L., Salgueiro, M., Sayans-Jiménez, P., Blanc-Molina, A., García-Leiva, J. M., Calandre, E. P. y Rojas, A. J. Propiedades psicométricas de la versión en español del Cuestionario de Necesidades Interpersonales de 12 ítems en pacientes con síndrome de fibromialgia. Anales de Psicología. 2018; 34(2), 274-282. https://doi.org/10.6018/analesps.34.2.293101 | ||
| 21928908 | Background | Van Orden KA, Cukrowicz KC, Witte TK, Joiner TE. Thwarted belongingness and perceived burdensomeness: construct validity and psychometric properties of the Interpersonal Needs Questionnaire. Psychol Assess. 2012 Mar;24(1):197-215. doi: 10.1037/a0025358. Epub 2011 Sep 19. | |
| Background | García, F. y Musitu, G. (1999). Autoconcepto Forma 5 (AF5). TEA Ediciones. | ||
| Background | Baztán, J. J., Pérez del Molino, J., Alarcón, T., San Cristóbal, E., Izquierdo, G. y Manzabeitia, J. Índice de Barthel: instrumento válido para la valoración funcional de pacientes con enfermedad cerebrovascular. Revista Española de Geriatría y Gerontología. 1993; 28(1), 32-40. |
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The plan is open for other researchers to contact the principal investigator of the study.
The data is available from now until 2027.
The plan is open for other researchers to contact the principal investigator of the study.
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| ID | Term |
|---|---|
| D016135 | Spinal Dysraphism |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D009436 | Neural Tube Defects |
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D000013 | Congenital Abnormalities |
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| 3 months after the intervention |
| Coping strategies - The Brief Cope Stress Questionnaire | The Brief Cope Stress Questionnaire (COPE-28) is an instrument that consists of 28 items used to assess fourteen coping strategies: active coping, planning, instrumental support, emotional support, self-distraction, venting, disengagement, positive reinterpretation, denial, acceptance, religion, substance use, humor, and self-blame. Higher scores indicate greater use of specific coping strategies, while lower scores reflect less frequent use. | 3 months after the intervention |
| Interpersonal Needs - The Interpersonal Needs Questionnaire | The Interpersonal Needs Questionnaire (INQ) is designed to assess the degree of frustration with various interpersonal needs. This 12-item questionnaire is divided into two subscales: thwarted belongingness and perceived burdensomeness. Higher scores reflect higher levels of perceived burdensomeness and thwarted belongingness. | 3 months after the intervention |
| Background | Morán, C., Landero, R. y González, M. T. COPE-28: un análisis psicométrico de la versión en español del Brief COPE. Universitas Psychologica. 2010; 9(2), 543-552. |
| 16250744 | Background | Carver CS. You want to measure coping but your protocol's too long: consider the brief COPE. Int J Behav Med. 1997;4(1):92-100. doi: 10.1207/s15327558ijbm0401_6. |
| 14258950 | Background | MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available. |
| Background | Fernández-Montalvo, J. y Echeburúa, E. Variables psicopatológicas y distorsiones cognitivas de los maltratadores en el hogar: Un análisis descriptivo. Análisis y Modificación de Conducta. 1997; 23(88), 151-180. |
| Background | Rosenberg, A. (1965). Society and the adolescent self-image. Princenton. |
| 11485122 | Background | Diez-Quevedo C, Rangil T, Sanchez-Planell L, Kroenke K, Spitzer RL. Validation and utility of the patient health questionnaire in diagnosing mental disorders in 1003 general hospital Spanish inpatients. Psychosom Med. 2001 Jul-Aug;63(4):679-86. doi: 10.1097/00006842-200107000-00021. |
| 10568646 | Background | Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. 1999 Nov 10;282(18):1737-44. doi: 10.1001/jama.282.18.1737. |
| Background | López-Roig, S., Terol, M.C., Pastor, M.A., Neipp, M.C., Massutí, B., Rodríguez-Marín. J., Leyda, J.I., Martín-Aragón, M. y Sitges, E. Ansiedad y Depresión. Validación de la escala HAD en pacientes oncológicos. Revista de Psicología de la Salud. 2000; 12(2): 127-155. doi.org/10.21134/pssa.v12i2.787 |
| 6880820 | Background | Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x. |
| 21611868 | Background | Lucas-Carrasco R. The WHO quality of life (WHOQOL) questionnaire: Spanish development and validation studies. Qual Life Res. 2012 Feb;21(1):161-5. doi: 10.1007/s11136-011-9926-3. Epub 2011 May 25. |
| 9626712 | Background | Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL Group. Psychol Med. 1998 May;28(3):551-8. doi: 10.1017/s0033291798006667. |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |