NCT01543815

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2006

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 5, 2012

Completed
Last Updated

March 6, 2012

Status Verified

December 1, 2011

Enrollment Period

3.1 years

First QC Date

February 28, 2012

Last Update Submit

March 4, 2012

Conditions

Psychological Distress

Keywords

Psychological DistressDepressionAnxietyWell-Being TherapyHeart FailureQuality of LifeAdherence

Outcome Measures

Primary Outcomes (1)

  • Psychological distress

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

    Within one year after the treatment

Secondary Outcomes (3)

  • Quality of Life

    Within one year after the treatment

  • Medical Adherence

    Within one year after the treatment

  • Promotion of Healthy Lifestyle

    Within one year after the treatment

Study Arms (3)

WBT-WEB

EXPERIMENTAL

Well-Being Therapy based on Web Mobile technology

Behavioral: Well-Being Therapy based on Web Mobile Technology

CBT

ACTIVE COMPARATOR

Cognitive Behavior Therapy

Behavioral: Cognitive Behavior Therapy

CM

NO INTERVENTION

Standardized Care Management

Other: Standardized Care Management

Interventions

Well-Being Therapy based on Web Mobile TechnologyBEHAVIORAL

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.

WBT-WEB
Cognitive Behavior TherapyBEHAVIORAL

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.

CBT
Standardized Care ManagementOTHER

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

CM

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 22943627DERIVED

MeSH Terms

Conditions

DepressionAnxiety DisordersHeart Failure

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Angelo Compare, Ph.D

    University of Bergamo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

February 28, 2012

First Posted

March 5, 2012

Study Start

January 1, 2006

Primary Completion

February 1, 2009

Study Completion

December 1, 2010

Last Updated

March 6, 2012

Record last verified: 2011-12