Psychosocial Teleassistance Programme for Adults With Spina Bifida

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Deusto

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

35 Participants
are divided into 2 treatment groups
Group A: Psychosocial teleassistance interventionExperimental treatment 1 intervention
Group B: Wait listExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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
2

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
3

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

Other outcomes

Sponsors and contacts

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