Well-Being Therapy by Personalized Mobile Technology Program for Psychological Distress and Promote Healthy Behaviors

NCT ID: NCT01543815

Last Updated: 2012-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2010-12-31

Brief Summary

The WELL-ME study is a three-arm randomized controlled clinical trial (RCT). The aim of this RCT is to compare the effectiveness of the Well Being Web Based Therapy (WBT-Web) with the gold standard CBT (Cognitive Behavior Therapy) and standard clinical procedure of patients' management (CM) for psychological distress and promotion of healthy behaviors in Cardiac Patients.

Detailed Description

Cardiac disease (CD) affects millions of European and Americans and new diagnosis rates are expected to almost triple over the next 30 years as our population ages. Affective disorders including clinical depression, anxiety and psychological distress are common in patients with CD. Furthermore, the presence of these disorders significantly impacts quality of life, adherence to medical prescription and healthy behaviors. The prevalence of depression, ranging from 11% to 25% among heart disease outpatients and 35% to 70% among those who are hospitalized. Psychological depression appears to be an important predictor of rehospitalization among persons who have been admitted with coronary artery disease. In addition, depression in patients with heart failure was found to be associated with the course of the disease and its prognosis. The high prevalence of psychological distress among the population of patients with heart failure, along with the broad impact on the patient's quality of life, requires attention to detail and the implementation of interventions aimed at reducing levels of distress. Very few studies describe interventions aimed at alleviating distress in patients with heart failure. Cognitive Behavioral Therapy (CBT) is reported to improve both the functional and emotional levels of these patients, resulting in the relief of their symptoms of depression. Recently Well Being Therapy WBT) have showed promising outcomes findings for depression and distress. There is a need to treat patients in their real life setting. Recent technological innovations in the ICT provide to monitor and treat the patient at a distance outside the hospital. The aim in this study is to study the effectiveness of the WBT-WEB in reducing psychological distress, and improving QoL, healthy behaviors and medical adherence in HR compared to a CBT and standard clinical procedure of patients' management (CM). The same protocol will be carried out in two centres (Hospital de Terrassa, Barcelona, Spain; National and Kapodistrian University of Athens, Greece). 300 patients diagnosed with cardiac disease, and with psychological distress, assessed by Hospital Anxiety and Depression Scale (HADS) will be randomized to one of three treatment groups: 1) WBT-WEB; 2) CBT and 3) CM. A one-year follow-up will be performed. It is expected that WBT-WEB may significantly decrease psychological distress and increase QoL, healthy behaviors and medical adherence at follow-up compared to clinical management.

Conditions

Psychological Distress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

WBT-WEB

Well-Being Therapy based on Web Mobile technology

Group Type: EXPERIMENTAL

Well-Being Therapy based on Web Mobile Technology

Intervention Type: BEHAVIORAL

The techniques included in WBT may be used in overcoming impairments in environmental mastery, purpose in life, personal growth, autonomy, self-acceptance and positive relations with others.

CBT

Cognitive Behavior Therapy

Group Type: ACTIVE_COMPARATOR

Cognitive Behavior Therapy

Intervention Type: BEHAVIORAL

CBT involves several essential features: identifying and correcting inaccurate thoughts associated with depressed feelings (cognitive restructuring); helping patients to engage more often in enjoyable activities (behavioral activation); enhancing problem-solving skills; providing instruction and guidance in specific strategies for solving problems.

CM

Standardized Care Management

Group Type: NO_INTERVENTION

Standardized Care Management

Intervention Type: OTHER

CM will consist of reviewing the patients' clinical status, and providing the patient with support and advice if necessary.

Interventions

Well-Being Therapy based on Web Mobile Technology

The techniques included in WBT may be used in overcoming impairments in environmental mastery, purpose in life, personal growth, autonomy, self-acceptance and positive relations with others.

Intervention Type: BEHAVIORAL

Cognitive Behavior Therapy

CBT involves several essential features: identifying and correcting inaccurate thoughts associated with depressed feelings (cognitive restructuring); helping patients to engage more often in enjoyable activities (behavioral activation); enhancing problem-solving skills; providing instruction and guidance in specific strategies for solving problems.

Intervention Type: BEHAVIORAL

Standardized Care Management

CM will consist of reviewing the patients' clinical status, and providing the patient with support and advice if necessary.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Cardiac Diseases
• a current diagnosis of at least one of the following: major or minor depression, dysthymia, anxiety according, to DSM-IV criteria, and HADS criteria
• Mini-Mental State Examination score higher than 24
• written informed consent provided by the patient to participate

Exclusion Criteria

• uncertain prognosis for 12 months due to other conditions
• acute coronary disease in recent months.
• existence of another life-threatening illness of the patient (such as active cancer, chronic kidney failure).
• severe neurological problem (Brain syndrome / orientation problem/ difficult peripheral neuropathy).
• severe mental illness (active psychosis / suicide risk / severe dementia).
• linguistic limitations (such as stuttering / untreated audio impairment).
• a significant functional problem (such as unconsciousness / connection to respiration device / confined to a wheelchair or bed / severe walking disability / needs help with complete basic daily activities).
• objective limit that endangers liability for participation in the seven meetings (such as remote residential / tourist / convict / drug addict).

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bergamo

OTHER

Sponsor Role: lead

Responsible Party

Angelo Compare

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Angelo Compare, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of Bergamo

References

Compare A, Kouloulias V, Apostolos V, Pena WM, Molinari E, Grossi E, Efstathios E, Carenini M. WELL.ME - Wellbeing therapy based on real-time personalized mobile architecture, vs. cognitive therapy, to reduce psychological distress and promote healthy lifestyle in cardiovascular disease patients: study protocol for a randomized controlled trial. Trials. 2012 Sep 3;13:157. doi: 10.1186/1745-6215-13-157.

Reference Type: DERIVED

PMID: 22943627 (View on PubMed)

Other Identifiers

029399

Identifier Type: OTHER

Identifier Source: secondary_id

NCT00289921

Identifier Type: -

Identifier Source: org_study_id