Psychosocial Teleassistance Programme for Adults With Spina Bifida

NCT07178873 | Recruiting

• 1 other identifier: Neuro-e-Motion SB
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spina Bifida; Self Esteem; Quality of Life (QOL); Self Concept; Anxiety; Depression; Interpersonal Needs

Outcome Measures

Primary Outcomes (5)

• 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.

  3 months after the intervention

Secondary Outcomes (3)

• Functionality - The Barthel Index

  3 months after the intervention

• Coping strategies - The Brief Cope Stress Questionnaire

  3 months after the intervention

• Interpersonal Needs - The Interpersonal Needs Questionnaire

  3 months after the intervention

Study Arms (2)

Psychosocial teleassistance intervention

EXPERIMENTAL

Psychosocial intervention, comprising 10 group sessions, followed by two 3-month follow-up sessions, is offered.

Behavioral: Psychosocial teleassistance intervention

Wait list

EXPERIMENTAL

Waiting list control group.

Behavioral: Psychosocial teleassistance intervention

Interventions

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.

Psychosocial teleassistance intervention; Wait list

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Deusto: lead

Study Sites (1)

University of Deusto

Bilbao, Bizkaia, 48007, Spain

RECRUITING

Related Publications (15)

• 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

  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.

  PMID: 21928908 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.

  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.

  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.

  PMID: 16250744 BACKGROUND

• MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.

  PMID: 14258950 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.

  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.

  PMID: 11485122 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.

  PMID: 10568646 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

  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.

  PMID: 6880820 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.

  PMID: 21611868 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.

  PMID: 9626712 BACKGROUND

MeSH Terms

Conditions

Spinal Dysraphism; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Mental Disorders; Behavioral Symptoms; Behavior

Central Study Contacts

Óscar Martínez, PhD

CONTACT

+ 34 944 139 113; oscar.martinez@deusto.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 17, 2025
• Study Start: June 25, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.

Locations

ES (1)