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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psychological Intervention | Experimental | A weekly combined face to face & telephone-based PI (F-TPI); Psychological Intervention and medical therapy |
|
| A telephone-based PI (TPI) | Experimental | Psychological Intervention - A telephone-based PI (TPI); Psychological Intervention and medical therapy |
|
| Optimal medical therapy | No Intervention | Patients will receive optimal medical therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychological Intervention | Other |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giulia Prinzi, MA | IRCCS San Raffaele Pisana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS San Raffaele Pisana | Roma | I-00163 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16250744 | Background | Carver CS. You want to measure coping but your protocol's too long: consider the brief COPE. Int J Behav Med. 1997;4(1):92-100. doi: 10.1207/s15327558ijbm0401_6. | |
| 27332504 | Background | Celli B, Tetzlaff K, Criner G, Polkey MI, Sciurba F, Casaburi R, Tal-Singer R, Kawata A, Merrill D, Rennard S; COPD Biomarker Qualification Consortium. The 6-Minute-Walk Distance Test as a Chronic Obstructive Pulmonary Disease Stratification Tool. Insights from the COPD Biomarker Qualification Consortium. Am J Respir Crit Care Med. 2016 Dec 15;194(12):1483-1493. doi: 10.1164/rccm.201508-1653OC. |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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Not provided
| ID | Term |
|---|---|
| D000083626 | Psychosocial Intervention |
| D044623 | Nutrition Therapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D013812 | Therapeutics |
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|
|
| 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 ) |
| 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 |
| 26629192 | Background | Chen Q, Wu C, Gao Y, Chen L, Liu Y. A clinical study on the role of psychosomatic therapy in evaluation and treatment of patients with chronic obstructive pulmonary disease complicated with anxiety-depression disorder. Int J Clin Exp Med. 2015 Sep 15;8(9):16613-9. eCollection 2015. |
| 7480853 | Background | Graydon JE, Ross E. Influence of symptoms, lung function, mood, and social support on level of functioning of patients with COPD. Res Nurs Health. 1995 Dec;18(6):525-33. doi: 10.1002/nur.4770180608. |
| 27611807 | Background | Guell MR, Cejudo P, Ortega F, Puy MC, Rodriguez-Trigo G, Pijoan JI, Martinez-Indart L, Gorostiza A, Bdeir K, Celli B, Galdiz JB. Benefits of Long-Term Pulmonary Rehabilitation Maintenance Program in Patients with Severe Chronic Obstructive Pulmonary Disease. Three-Year Follow-up. Am J Respir Crit Care Med. 2017 Mar 1;195(5):622-629. doi: 10.1164/rccm.201603-0602OC. |
| 27036694 | Background | Healy K. A Theory of Human Motivation by Abraham H. Maslow - reflection. Br J Psychiatry. 2016 Apr;208(4):313. doi: 10.1192/bjp.bp.115.179622. No abstract available. |
| 25359355 | Background | Holland AE, Spruit MA, Troosters T, Puhan MA, Pepin V, Saey D, McCormack MC, Carlin BW, Sciurba FC, Pitta F, Wanger J, MacIntyre N, Kaminsky DA, Culver BH, Revill SM, Hernandes NA, Andrianopoulos V, Camillo CA, Mitchell KE, Lee AL, Hill CJ, Singh SJ. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1428-46. doi: 10.1183/09031936.00150314. Epub 2014 Oct 30. |
| 1595997 | Background | Jones PW, Quirk FH, Baveystock CM, Littlejohns P. A self-complete measure of health status for chronic airflow limitation. The St. George's Respiratory Questionnaire. Am Rev Respir Dis. 1992 Jun;145(6):1321-7. doi: 10.1164/ajrccm/145.6.1321. |
| 15821196 | Background | Kunik ME, Roundy K, Veazey C, Souchek J, Richardson P, Wray NP, Stanley MA. Surprisingly high prevalence of anxiety and depression in chronic breathing disorders. Chest. 2005 Apr;127(4):1205-11. doi: 10.1378/chest.127.4.1205. |
| 8346332 | Background | Lazarus RS. Coping theory and research: past, present, and future. Psychosom Med. 1993 May-Jun;55(3):234-47. doi: 10.1097/00006842-199305000-00002. No abstract available. |
| 27579637 | Background | Martinez FD. Early-Life Origins of Chronic Obstructive Pulmonary Disease. N Engl J Med. 2016 Sep 1;375(9):871-8. doi: 10.1056/NEJMra1603287. No abstract available. |
| 18510641 | Background | Martinu T, Babyak MA, O'Connell CF, Carney RM, Trulock EP, Davis RD, Blumenthal JA, Palmer SM; INSPIRE Investigators. Baseline 6-min walk distance predicts survival in lung transplant candidates. Am J Transplant. 2008 Jul;8(7):1498-505. doi: 10.1111/j.1600-6143.2008.02264.x. |
| 18842932 | Background | Maurer J, Rebbapragada V, Borson S, Goldstein R, Kunik ME, Yohannes AM, Hanania NA; ACCP Workshop Panel on Anxiety and Depression in COPD. Anxiety and depression in COPD: current understanding, unanswered questions, and research needs. Chest. 2008 Oct;134(4 Suppl):43S-56S. doi: 10.1378/chest.08-0342. |
| 24834459 | Background | Perret JL, Walters EH, Abramson MJ, McDonald CF, Dharmage SC. The independent and combined effects of lifetime smoke exposures and asthma as they relate to COPD. Expert Rev Respir Med. 2014 Aug;8(4):503-14. doi: 10.1586/17476348.2014.905913. Epub 2014 May 16. |
| 21810710 | Background | Qaseem A, Wilt TJ, Weinberger SE, Hanania NA, Criner G, van der Molen T, Marciniuk DD, Denberg T, Schunemann H, Wedzicha W, MacDonald R, Shekelle P; American College of Physicians; American College of Chest Physicians; American Thoracic Society; European Respiratory Society. Diagnosis and management of stable chronic obstructive pulmonary disease: a clinical practice guideline update from the American College of Physicians, American College of Chest Physicians, American Thoracic Society, and European Respiratory Society. Ann Intern Med. 2011 Aug 2;155(3):179-91. doi: 10.7326/0003-4819-155-3-201108020-00008. |
| 28417609 | Background | Russo P, Prinzi G, Kisialiou A, Cardaci V, Stirpe E, Conti V, Fini M, Bonassi S. WITHDRAWN: Action plans and coping strategies in elderly COPD patients influence the result of pulmonary rehabilitation: an observational study. Eur J Phys Rehabil Med. 2017 Apr 14. doi: 10.23736/S1973-9087.17.04501-4. Online ahead of print. |
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| 27264777 | Background | Vanfleteren LEGW, Spruit MA, Wouters EFM, Franssen FME. Management of chronic obstructive pulmonary disease beyond the lungs. Lancet Respir Med. 2016 Nov;4(11):911-924. doi: 10.1016/S2213-2600(16)00097-7. Epub 2016 Jun 2. |
| 18222685 | Background | Vogele C, von Leupoldt A. Mental disorders in chronic obstructive pulmonary disease (COPD). Respir Med. 2008 May;102(5):764-73. doi: 10.1016/j.rmed.2007.12.006. Epub 2008 Jan 28. |
| 25943943 | Background | Woodruff PG, Agusti A, Roche N, Singh D, Martinez FJ. Current concepts in targeting chronic obstructive pulmonary disease pharmacotherapy: making progress towards personalised management. Lancet. 2015 May 2;385(9979):1789-1798. doi: 10.1016/S0140-6736(15)60693-6. |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |