Improving Psychosocial Well-being in COPD Patients in Rehabilitation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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COPD

Intervention / Treatment
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* Other: Psychological Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of COPD Mini-Mental State Examination (MMSE) ≥ 26 6 Minute Walking Test ≥ 90 meters , at admission Obtaining Written Informed Consent Exclusion Criteria: Comorbidity influencing respiratory ability and functionality Delta 6 Minute Walking Distance < 60 meters, at time of admission
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psychological Intervention<br>A weekly combined face to face & telephone-based PI (F-TPI); Psychological Intervention and medical therapy | Other: Psychological Intervention<br>* 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 . 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. CTRL group with COPD SoC without PI will follow the standard follow-up program for COPD patients after PR.<br>* Other names: Medical therapy;|
| Experimental: A telephone-based PI (TPI)<br>Psychological Intervention - A telephone-based PI (TPI); Psychological Intervention and medical therapy | Other: Psychological Intervention<br>* 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 . 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. CTRL group with COPD SoC without PI will follow the standard follow-up program for COPD patients after PR.<br>* Other names: Medical therapy;|
| No Intervention: Optimal medical therapy<br>Patients will receive optimal medical therapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Health related Quality of Life evaluated by the St. George's Respiratory Questionnaire | the St. George's Respiratory Questionnaire score | 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 | 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 | day 0 to day 182 | 
| Maintenance of Functional Exercise evaluated by the Six Minute Walking Test | the Six Minute Walking Test score | day 0 to day 182 | 
| Maintenance of Respiratory Capacity evaluated by the Borg scale | the Borg scale score | day 0 to day 182 | 
| Assessment of dyspnea in activities of daily living by the Medical Research Council scale | the Medical Research Council score | 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 | day 0 to day 21 (period of the Pulmonary Rehabilitation) | 
| Assessment of disability by the Barthel Index | Barthel Index score | day 0 to day 21 (period of the Pulmonary Rehabilitation ) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in psychological status evaluated by the Symptom Check List (SCL-90) | the SCL-90 scores | day 0 to day 182 | 
| Assessment of the severity of depression by the Beck Depression Inventory II | the Beck Depression Inventory score | 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 | day 0 to day 182 | 
| Change in the use of the Coping Strategies evaluated by Brief-COPE | Brief-COPE | day 0 to day 182 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rehabilitation, Psychological Intervention, Quality of life