An interventional study of Psychological Intervention in COPD, sponsored by IRCCS San Raffaele Roma. Completed at 1 site in Italy. Per ClinicalTrials.gov, last updated 2023-06-26.
Sponsored by IRCCS San Raffaele Roma · Not applicable, Interventional, and Treatment
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.
In this pilot study we will perform two different methodologies of the Psychological Intervention: a telephone-based Psychological Intervention and combined face to face \& telephone-based Psychological Intervention, integrating the COPD rehabilitation.
The study will be carried out in a real life setting. An initial sample of 36 COPD patients satisfying the inclusion criteria and accepting the participation of the study will be enrolled at the PR Unit of the IRCCS "San Raffaele Pisana" Roma-Italy. The study enrollment period will be of maximum six months, the treatment period is of six months, and the interim treatment evaluation is of three months will be performed. Max study duration will be of 12 months.
The participants will be recruited prospectively from consecutively admitted patients to the inpatient PR Unit. Participants will be required to have the diagnosis of COPD according to the ATS' Guideline [Qaseem et al., 2011]. All participants will sign informed consent approved by the Institutional Ethic Committee.
Exclusion Criteria:
A weekly combined face to face \& telephone-based PI (F-TPI); Psychological Intervention and medical therapy
Other: Psychological Intervention
Psychological Intervention - A telephone-based PI (TPI); Psychological Intervention and medical therapy
Other: Psychological Intervention
Patients will receive optimal medical therapy
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.
Also known as: Medical therapy
Change in Health related Quality of Life evaluated by the St. George's Respiratory Questionnaire
the St. George's Respiratory Questionnaire score
Time frame: day 0 to day 182
Change in Quality of Life evaluated by the Short Form Health Survey General and Mental Health
the Short Form Health Survey General and Mental Health score
Time frame: day 0 to day 182
Change in the degree of enjoyment and satisfaction in areas of daily functioning, evaluated by the Quality Of Life Enjoyment And Satisfaction Questionnaire
the Quality Of Life Enjoyment And Satisfaction Questionnaire score
Time frame: day 0 to day 182
Maintenance of Functional Exercise evaluated by the Six Minute Walking Test
the Six Minute Walking Test score
Time frame: day 0 to day 182
Maintenance of Respiratory Capacity evaluated by the Borg scale
the Borg scale score
Time frame: day 0 to day 182
Assessment of dyspnea in activities of daily living by the Medical Research Council scale
the Medical Research Council score
Time frame: day 0 to day 21 (period of the Pulmonary Rehabilitation )
Assessment of Respiratory Capacity by the Maugeri Foundation Respiratory Failure Questionnaire
the Maugeri Foundation Respiratory Failure score
Time frame: day 0 to day 21 (period of the Pulmonary Rehabilitation)
Assessment of disability by the Barthel Index
Barthel Index score
Time frame: day 0 to day 21 (period of the Pulmonary Rehabilitation )
Change in psychological status evaluated by the Symptom Check List (SCL-90)
the SCL-90 scores
Time frame: day 0 to day 182
Assessment of the severity of depression by the Beck Depression Inventory II
the Beck Depression Inventory score
Time frame: day 0 to day 182
Assessment of different types of anxiety, state anxiety and trait anxiety, by State-Trait Anxiety Inventory Form Y.
the State-Trait Anxiety Inventory scores
Time frame: day 0 to day 182
Change in the use of the Coping Strategies evaluated by Brief-COPE
Brief-COPE
Time frame: day 0 to day 182
Plan to share: No
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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IRCCS San Raffaele Roma