CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 31 enrolled
Drug / intervention
Psychological Interventionother
Likely dose
Not stated in record
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Search/NCT03470025
NCT03470025N/ACompleted

Psychological Intervention to Improve the COPD Patients' Psychosocial Well-being

IRCCS San Raffaele Roma·interventional·Posted Mar 19, 2018·Updated Jun 26, 2023

In Brief

A clinical study evaluating Psychological Intervention for COPD. Completed, enrolled 31 participants across 1 site.

Detailed Summary

Because of a lack of clinical trials, there is currently a paucity of evidence on the most effective strategies to identify and address psychological co-morbidity in COPD, or on targeting these interventions to specific patient groups. The relationship between physiological disease impairment and patient's disease experience is weak. Some patients have highly impaired Quality of life (QoL) despite relatively minor lung function impairment, and others have good QoL despite severe lung function impairment. It is likely that psychological and behavioral factors may be relevant; moreover the coping strategies used by patients and their relationship to individual psychological factors have been incompletely explored. Pulmonary Rehabilitation (PR) is part of integrated COPD patient management and its potential impact on QoL should be underlined: several studies have found that physical exercise has a beneficial effect on depression symptoms \[GOLD, 2017\]. Before initiating PR a comprehensive and careful assessment should be performed: treatment goals, specific healthcare needs, smoking status, nutritional health, self-management capacity, health educational, psychological health status and social circumstances, medical history and comorbidities, and exercise capabilities and limitations. Moreover, PR has beneficial effects on mood status and daily activities. Sustaining Pulmonary Rehabilitation benefits and regular exercise over the long term is difficult without any maintenance strategy. The main aim of this study is to assess the Effect of the Psychological Intervention (PI) on Quality of life, psychological status and well-being, and the maintenance of Pulmonary Rehabilitation benefits, in COPD patients. A PI based on psychoeducation and psychological and emotional support may be a key to improve Quality of life and to bring COPD patients to show a greater awareness of their health status.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOPD
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMar 19, 2018
Enrollment StartJan 10, 2018
Primary CompletionMay 30, 2019
Study CompletionDec 31, 2019
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 8.3 years ago

Interventions

Psychological Interventionother

1. F-TPI group will be followed for a period of six months with a telephone-based and a face to face psychological intervention, performed by a clinical psychotherapist . 2. TPI group will be followed for a period of six months with a TPI characterized by 10 telephone clinical interviews, performed by a clinical psychotherapist. 3. CTRL group with COPD SoC without PI will follow the standard follow-up program for COPD patients after PR.