NCT04898972

Mindfulness-based Intervention in COPD Dyads

Mindfulness-based Stress Reduction Intervention in Patients With COPD and Their Caregivers

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Campus Bio-Medico University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the effectiveness of a Mindfulness-Based Stress Reduction intervention (MBSRI) on the reduction of stress, anxiety, and depression in people with COPD and their family caregivers. The experimental group will receive the MBSRI and the control group an informational intervention on stress management.

Detailed description

People affected by Chronic Obstructive Pulmonary Disease (COPD) and their family caregivers (named dyads) often suffer from psychological distress, because of the physical problems and social isolation imposed by the disease. Such psychological distress can influence the ability of patients and caregivers to manage the disease. Mindfulness-based interventions have showed benefits in improving the psychological status in various clinical situations. A 8-week mindfulness based-stress reduction intervention will be offered to a group of COPD patient-caregiver dyads and its effectiveness will be assessed comparing the effects on a control group to whom an informational intervention on stress reduction will be carried out.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
BEHAVIORAL	Mindfulness-based stress reduction intervention	The 8-group sessions of MBSR will be conducted once a week, lasting two and a half hours, with two additional sessions in the following two months. Between sessions, participants will have to practice at home for 45 minutes a day, 6 days a week. For the practice, patients and caregivers will be provided with audio files containing the meditations proposed in the classroom, readings, and the diary of the practice. During the sessions, the following mindfulness-based techniques will be introduced: body scan; sitting meditation; awareness movement exercises; and walking meditation.The sessions will be held face to face or online using common videoconferencing platforms, such as Skype or Zoom, based on the preferences of the participants. This will facilitate the participation of patients and caregivers, overcoming the obstacles related to travel. The course will be taught by certified mindfulness teachers with experience in MBSR interventions on patients with respiratory diseases.
BEHAVIORAL	Information on stress reduction	COPD patient-caregiver dyads will be delivered by hand, sent by email or by post an information booklet "Coping with your chronic disease", targeting COPD patients, to teach them how to manage stress. This booklet, available in Italian, provides simple information on the meaning of stress and anxiety, and suggests some actions that people can implement at home to reduce stress.

Timeline

• Start date: 2021-04-20
• Primary completion: 2023-12-30
• Completion: 2023-12-30
• First posted: 2021-05-24
• Last updated: 2021-08-03

Locations

1 site across 1 country: Italy