An interventional study of Psychosocial teleassistance intervention in Spina Bifida, Self Esteem and Quality of Life (QOL), sponsored by University of Deusto. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-12-10.
Sponsored by University of Deusto · Not applicable, Interventional, and Treatment
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.
142 studies on the registry are indexed under Spinal Dysraphism; 39 are open to participants now.
This study's planned enrollment of 35 is above the median of 30 across 91 interventional studies indexed under Spinal Dysraphism.
Browse Spinal Dysraphism studies →University of Deusto is the lead sponsor of 20 studies on the registry; 7 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Psychosocial intervention, comprising 10 group sessions, followed by two 3-month follow-up sessions, is offered.
Behavioral: Psychosocial teleassistance intervention
Waiting list control group.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months after the intervention
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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months after the intervention
Plan to share: Yes — The plan is open for other researchers to contact the principal investigator of the study.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: The data is available from now until 2027.
Access criteria: The plan is open for other researchers to contact the principal investigator of the study.
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