Improving Psychosocial Well-being in COPD Patients in Rehabilitation
NCT ID: NCT03470025
Last Updated: 2023-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
31 participants
INTERVENTIONAL
2018-01-10
2019-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Status and Develepment Mental Quality of Life COPD/IPF Inpatients Before and After Pulmonary Rehabilitation
NCT03477526
Assessment of Stress Levels and Depressive and Anxiety Symptoms in Patients With COPD
NCT04726917
Illness Expectations in COPD
NCT06509308
A Psychological Intervention to Promote Acceptance and Adherence to NIV in People With COPD
NCT02499653
REspiratory reHABilitation and PSYchiatric Comorbidities
NCT06229600
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Psychological Intervention
A weekly combined face to face \& telephone-based PI (F-TPI); Psychological Intervention and medical therapy
Psychological Intervention
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.
A telephone-based PI (TPI)
Psychological Intervention - A telephone-based PI (TPI); Psychological Intervention and medical therapy
Psychological Intervention
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.
Optimal medical therapy
Patients will receive optimal medical therapy
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Psychological Intervention
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Mini-Mental State Examination (MMSE) ≥ 26
* 6 Minute Walking Test ≥ 90 meters , at admission
* Obtaining Written Informed Consent
Exclusion Criteria
* Delta 6 Minute Walking Distance \< 60 meters, at time of admission
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
IRCCS San Raffaele Roma
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Giulia Prinzi, MA
Role: PRINCIPAL_INVESTIGATOR
IRCCS San Raffaele Pisana
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
IRCCS San Raffaele Pisana
Roma, , Italy
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Smoller JW, Pollack MH, Otto MW, Rosenbaum JF, Kradin RL. Panic anxiety, dyspnea, and respiratory disease. Theoretical and clinical considerations. Am J Respir Crit Care Med. 1996 Jul;154(1):6-17. doi: 10.1164/ajrccm.154.1.8680700.
Usmani ZA, Carson KV, Heslop K, Esterman AJ, De Soyza A, Smith BJ. Psychological therapies for the treatment of anxiety disorders in chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2017 Mar 21;3(3):CD010673. doi: 10.1002/14651858.CD010673.pub2.
van Manen JG, Bindels PJ, Dekker FW, IJzermans CJ, van der Zee JS, Schade E. Risk of depression in patients with chronic obstructive pulmonary disease and its determinants. Thorax. 2002 May;57(5):412-6. doi: 10.1136/thorax.57.5.412.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RP 22/17
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.