Psychosocial Teleassistance Programme for Adults With Spina Bifida
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Psychosocial teleassistance intervention.
- Who it may be relevant to
- Registry conditions: Spina Bifida, Self Esteem, Quality of Life (QOL), Self Concept. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effects of a Psychosocial Teleassistance Programme for Adults With Spina Bifida
Overview
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.
Detailed description
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.
Interventions
- Behavioral Psychosocial teleassistance intervention
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.
Primary outcome measures
- Quality of life - The World Health Organization WHOQOL-BREF Quality of Life Assessment [Time frame: 3 months after the intervention]
- Anxiety and depression - The Hospital Anxiety and Depression Scale [Time frame: 3 months after the intervention]
- Depression - The Patient Health Questionnaire [Time frame: 3 months after the intervention]
- Self-esteem - The Rosenberg Self-Esteem Scale [Time frame: 3 months after the intervention]
- Self-Concept - Self-Concept Questionnaire Form-5 [Time frame: 3 months after the intervention]
Secondary outcome measures (3)
- Functionality - The Barthel Index [Time frame: 3 months after the intervention]
- Coping strategies - The Brief Cope Stress Questionnaire [Time frame: 3 months after the intervention]
- Interpersonal Needs - The Interpersonal Needs Questionnaire [Time frame: 3 months after the intervention]
Eligibility criteria
Inclusion criteria
- To be diagnosed with spina bifida by a specialist.
- Being between 18 and 75 years old.
- Having their informed consent or the informed consent of their legal guardians.
- Having Spanish as one of their main languages.
- Having access to a computer (with a camera, microphone and speakers integrated) and Internet connection to take part in the videoconferences.
Exclusion criteria
- Age that is inconsistent with the established range.
- The presence of any comorbid diagnosis or sensory deficit that would impede the effective execution of the intervention's activities.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- University of Deusto — Bilbao
Publications
- 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
- 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. PMID 21928908
- García, F. y Musitu, G. (1999). Autoconcepto Forma 5 (AF5). TEA Ediciones.
- 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.
- 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.
- 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. PMID 16250744
- MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available. PMID 14258950
- 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.
Identifiers
NCT: NCT07178873 · Neuro-e-Motion SB