The Effects of Mindfulness-Based Stress Reduction Program for Family or Caregivers of Children With Motor Disabilities

NCT ID: NCT06557486

Last Updated: 2024-08-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-31
• Study Completion Date: 2025-06-30

Brief Summary

The present study aims to investigate the effect of a mindfulness-based program on perceived stress, severity of anxiety, parents'/caregivers' quality of life and their children, cortisol and IL-6 blood concentrations.

Conditions

Stress, Psychological; Stress, Emotional; Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Mindfulness-Based Stress reduction arm

Group Type: EXPERIMENTAL

Mindfulness-Based Stress reduction

Intervention Type: BEHAVIORAL

Participants assigned to the 8-week mindfulness program attended weekly 120-150 minute in-person group sessions for the entire duration. In these sessions, the instructor progressively will introduce and guide formal mindfulness practices while facilitating the sharing of experiences.

Usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mindfulness-Based Stress reduction

Participants assigned to the 8-week mindfulness program attended weekly 120-150 minute in-person group sessions for the entire duration. In these sessions, the instructor progressively will introduce and guide formal mindfulness practices while facilitating the sharing of experiences.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Not having attended previously a mindfulness course
• A score equal to or greater than 23 points at the PSS.
• >18 years old
• Children <18y with motor/physical disability due to a Neurological disorder.
• Spanish/Catalan speaking

Exclusion Criteria

• Currently using drugs or any kind of medication related to stress, depression, anxiety or sleeping pills, such as steroid medicines.
• Regular meditation practice (once a week in the past 12 months)
• Diagnose of hypertension stage 2
• Pregnancy in the case of mothers
• Present hyperthyroidism
• Primary adrenal insufficiency syndromes such as Cushing syndrome or Addison disease
• Present any kind of infection or inflammation process, different from the interestingly to the present study that could differ the results

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitat de Lleida

OTHER

Sponsor Role: lead

Responsible Party

Clàudia Arumí

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Claudia Arumi

Lleida, , Spain

Countries

Spain

Other Identifiers

ULleida2

Identifier Type: -

Identifier Source: org_study_id