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Improving Psychosocial Well-being in COPD Patients in Rehabilitation

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03470025
Acronym
IMPROVE
Enrollment
31
Registered
2018-03-19
Start date
2018-01-10
Completion date
2019-12-31
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Keywords

Rehabilitation, Psychological Intervention, Quality of life

Brief 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.

Detailed description

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.

Interventions

OTHERPsychological 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.

Sponsors

IRCCS San Raffaele Roma
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Assessment of disability by the Barthel Indexday 0 to day 21 (period of the Pulmonary Rehabilitation )Barthel Index score
Maintenance of Functional Exercise evaluated by the Six Minute Walking Testday 0 to day 182the Six Minute Walking Test score
Maintenance of Respiratory Capacity evaluated by the Borg scaleday 0 to day 182the Borg scale score
Assessment of dyspnea in activities of daily living by the Medical Research Council scaleday 0 to day 21 (period of the Pulmonary Rehabilitation )the Medical Research Council score
Assessment of Respiratory Capacity by the Maugeri Foundation Respiratory Failure Questionnaireday 0 to day 21 (period of the Pulmonary Rehabilitation)the Maugeri Foundation Respiratory Failure score
Change in Health related Quality of Life evaluated by the St. George's Respiratory Questionnaireday 0 to day 182the St. George's Respiratory Questionnaire score
Change in Quality of Life evaluated by the Short Form Health Survey General and Mental Healthday 0 to day 182the Short Form Health Survey General and Mental Health score
Change in the degree of enjoyment and satisfaction in areas of daily functioning, evaluated by the Quality Of Life Enjoyment And Satisfaction Questionnaireday 0 to day 182the Quality Of Life Enjoyment And Satisfaction Questionnaire score

Secondary

MeasureTime frameDescription
Assessment of the severity of depression by the Beck Depression Inventory IIday 0 to day 182the Beck Depression Inventory score
Assessment of different types of anxiety, state anxiety and trait anxiety, by State-Trait Anxiety Inventory Form Y.day 0 to day 182the State-Trait Anxiety Inventory scores
Change in the use of the Coping Strategies evaluated by Brief-COPEday 0 to day 182Brief-COPE
Change in psychological status evaluated by the Symptom Check List (SCL-90)day 0 to day 182the SCL-90 scores

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026