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

NCT01543815 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2012-03-06

No results posted yet for this study

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.

Conditions

  • Psychological Distress

Interventions

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.

Sponsors & Collaborators

  • University of Bergamo

    lead OTHER

Principal Investigators

  • Angelo Compare, Ph.D · University of Bergamo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2009-02-28
Completion
2010-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01543815 on ClinicalTrials.gov