Spina BifidaNCT07178873
Psychosocial Teleassistance Programme for Adults With Spina Bifida
A study testing Psychosocial teleassistance intervention in people with Spina Bifida and Self Esteem, run by University of Deusto at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spina Bifida, Self Esteem, Quality of Life (QOL)
- What is being tested?
- Psychosocial teleassistance intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSpain
- Study dates
- 25 Jun 2024to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
University of Deusto
Bilbao, Bizkaia, 48007
Óscar Martínez, PhD, oscar.martinez@deusto.es
About this study
Official title: Effects of a 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.
Read the 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.
- Conditions
- Spina Bifida, Self Esteem, Quality of Life (QOL), Self Concept, Anxiety, Depression
- Being tested
- Psychosocial teleassistance intervention
- Medical subject headings
- Spinal Dysraphism, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial teleassistance interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Psychosocial teleassistance intervention | Experimental | Psychosocial intervention, comprising 10 group sessions, followed by two 3-month follow-up sessions, is offered. Receives: Behavioral: Psychosocial teleassistance intervention |
| Wait list | Experimental | Waiting list control group. Receives: Behavioral: Psychosocial teleassistance intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months after the intervention
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 3 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start25 Jun 2024
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Spina BifidaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Deusto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07178873
- Sponsor's protocol ID
- Neuro-e-Motion SB
- Status last verified
- Dec 2025
- First submitted
- 10 Sep 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The plan is open for other researchers to contact the principal investigator of the study.
Publications
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
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.
PubMed 21928908García, F. y Musitu, G. (1999). Autoconcepto Forma 5 (AF5). TEA Ediciones.
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.
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.
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.
PubMed 16250744MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.
PubMed 14258950Fernández-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.
Rosenberg, A. (1965). Society and the adolescent self-image. Princenton.
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.
PubMed 11485122Spitzer 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.
PubMed 10568646López-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
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.
PubMed 6880820Lucas-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.
PubMed 21611868Development 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.
PubMed 9626712
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Psychosocial Teleassistance Programme for Adults With Spina Bifida
- ClinicalTrials.gov ID
- NCT07178873
- Acronym / sponsor ID
- Neuro-e-Motion SB
- Conditions
- Spina Bifida, Self Esteem, Quality of Life (QOL), Self Concept, Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University of DeustoUniversity, hospital or other
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 17 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychosocial teleassistance intervention | Experimental | Behavioral: Psychosocial teleassistance interventionPsychosocial intervention, comprising 10 group sessions, followed by two 3-month follow-up sessions, is offered. |
| Wait list | Experimental | Behavioral: Psychosocial teleassistance interventionWaiting list control group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychosocial teleassistance interventionThe 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. | Behavioural | Psychosocial teleassistance intervention, Wait list |
Primary outcome
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.
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.
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.
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.
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.
3 secondary outcomes
Functionality - The Barthel Index
Time frame: 3 months after the intervention
Coping strategies - The Brief Cope Stress Questionnaire
Time frame: 3 months after the intervention
Interpersonal Needs - The Interpersonal Needs Questionnaire
Time frame: 3 months after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- BackgroundOrdoñez-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: PubMed 21928908Van 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.
- BackgroundGarcía, F. y Musitu, G. (1999). Autoconcepto Forma 5 (AF5). TEA Ediciones.
- BackgroundBaztán, 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.
- BackgroundMorán, 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: PubMed 16250744Carver 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.
- Background: PubMed 14258950MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.
- BackgroundFernández-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.
- BackgroundRosenberg, A. (1965). Society and the adolescent self-image. Princenton.
- Background: PubMed 11485122Diez-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.
- Background: PubMed 10568646Spitzer 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.
- BackgroundLópez-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
- Individual participant dataSharing planned: Yes. The plan is open for other researchers to contact the principal investigator of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychosocial teleassistance intervention in people with Spina Bifida and Self Esteem, run by University of Deusto at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Óscar Martínez, PhD (+ 34 944 139 113 ext. 2687, oscar.martinez@deusto.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life - The World Health Organization WHOQOL-BREF Quality of Life Assessment (time frame: 3 months after the intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07178873, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.