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Completed

NCT Number: NCT01543815

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Well-Being Therapy based on Web Mobile Technology

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.

Cognitive Behavior Therapy

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.

Standardized Care Management

Other

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

Primary outcomes

  1. Psychological distress

    Time frame: Within one year after the treatment

    Depression, Anxiety, and well-being improvements (Psychological Distress Reduction)

Secondary outcomes

  1. Quality of Life

    Time frame: Within one year after the treatment

    Quality of Life

  2. Medical Adherence

    Time frame: Within one year after the treatment

  3. Promotion of Healthy Lifestyle

    Time frame: Within one year after the treatment

    Promotion of Healthy Lifestyle

Sponsors and collaborators

Lead sponsor

University of Bergamo

Other

Registry information

Official study title

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

Acronym: WELL-ME

Important dates

Study start
2006
Primary completion
2009
Study completion
2010
First posted
Mar 5, 2012
Registry last updated
Mar 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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