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NCT Number: NCT07178873

Psychosocial Teleassistance Programme for Adults With Spina Bifida

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Deusto

Bilbao, Bizkaia, 48007, Spain

Location status: Recruiting

Location contact

Óscar Martínez, PhD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Quality of life - The World Health Organization WHOQOL-BREF Quality of Life Assessment

    Time frame: 3 months after the intervention

    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.

  2. Anxiety and depression - The Hospital Anxiety and Depression Scale

    Time frame: 3 months after the intervention

    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. Depression - The Patient Health Questionnaire

    Time frame: 3 months after the intervention

    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.

  4. Self-esteem - The Rosenberg Self-Esteem Scale

    Time frame: 3 months after the intervention

    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.

  5. Self-Concept - Self-Concept Questionnaire Form-5

    Time frame: 3 months after the intervention

    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.

Secondary outcomes

  1. Functionality - The Barthel Index

    Time frame: 3 months after the intervention

    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.

  2. Coping strategies - The Brief Cope Stress Questionnaire

    Time frame: 3 months after the intervention

    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. Interpersonal Needs - The Interpersonal Needs Questionnaire

    Time frame: 3 months after the intervention

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Óscar Martínez, PhD

CONTACT

[email protected]

+ 34 944 139 113 ext. 2687

Sponsors and collaborators

Lead sponsor

University of Deusto

Other

Registry information

Official study title

Effects of a Psychosocial Teleassistance Programme for Adults With Spina Bifida

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 17, 2025
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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