NCT01543815

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

Well-Being Therapy for Psychological Distress and Enhancing Healthy Behaviors With Personalized Mobile Technology in Cardiac Patients: a Randomized Controlled-trial Study Protocol

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: University of Bergamo · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	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.
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.
OTHER	Standardized Care Management	CM will consist of reviewing the patients' clinical status, and providing the patient with support and advice if necessary.

Timeline

• Start date: 2006-01-01
• Primary completion: 2009-02-01
• Completion: 2010-12-01
• First posted: 2012-03-05
• Last updated: 2012-03-06