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

NCT06557486 | Not Yet Recruiting DMC

• 1 other identifier: ULleida2
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Perceived Stress

  To measure participants perceived stress, the Perceived Stress Scale 14 item Spanish version will be used (PSS 14). It consists of 14 items scored from 0 up to 4 (0=never, 1 = rarely 2= sometimes 3= usually 4 =almost always). The total scores on the scale can range from 0 (no stress) to 56 (extreme stress).

  baseline, two months (through study completion), and follow-up of one month

• Cortisol levels

  The cortisol measurement will be sampled with a serum blood test. It is recommended to advise the participants to be fasted. 63 Cortisol levels fluctuate throughout the day, being highest in the morning and lowest at night.63,64 The sample will be collected between 8-9 am to get the highest cortisol.

  baseline and two months (through study completion)

Secondary Outcomes (7)

• Severity of clinic anxiety

  baseline, two months (through study completion), and follow-up of one month

• Sleep Quality

  baseline, two months (through study completion), and follow-up of one month

• Quality of Life assessment

  baseline, two months (through study completion), and follow-up of one month

• Blood pressure

  baseline, two months (through study completion), and follow-up of one month

• Resting Heart rate

  baseline, two months (through study completion), and follow-up of one month

Study Arms (2)

Mindfulness-Based Stress reduction arm

EXPERIMENTAL

Behavioral: Mindfulness-Based Stress reduction

Usual care

NO INTERVENTION

Interventions

Mindfulness-Based Stress reduction 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.

Mindfulness-Based Stress reduction arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitat de Lleida: lead

Study Sites (1)

Claudia Arumi

Lleida, 25006, Spain

Location

MeSH Terms

Conditions

Stress, Psychological

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 16, 2024
• Study Start: January 1, 2025
• Primary Completion: March 1, 2025
• Study Completion: June 1, 2025
• Last Updated: August 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)