Anxiety, Depression, Interpersonal Needs, Quality of Life (QOL), Self Concept, Self Esteem, Spina Bifida
Conditions
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.
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
BEHAVIORALPsychosocial 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.
Sponsors
University of Deusto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-Concept - Self-Concept Questionnaire Form-5 | 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. |
| Anxiety and depression - The Hospital Anxiety and Depression Scale | 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. |
| Depression - The Patient Health Questionnaire | 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. |
| Self-esteem - The Rosenberg Self-Esteem Scale | 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. |
| Quality of life - The World Health Organization WHOQOL-BREF Quality of Life Assessment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Coping strategies - The Brief Cope Stress Questionnaire | 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. |
| Interpersonal Needs - The Interpersonal Needs Questionnaire | 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. |
| Functionality - The Barthel Index | 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. |
Countries
Spain
Contacts
Primary ContactÓscar Martínez, PhD
Outcome results
None listed