Psychological DistressWELL-MENCT01543815
Well-Being Therapy by Personalized Mobile Technology Program for Psychological Distress and Promote Healthy Behaviors
A study testing Well-Being Therapy based on Web Mobile Technology, Cognitive Behavior Therapy and Standardized Care Management in people with Psychological Distress, run by University of Bergamo.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Psychological Distress
- What is being tested?
- Well-Being Therapy based on Web Mobile Technology, Cognitive Behavior Therapy and Standardized Care Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
About this study
Official title: Well-Being Therapy for Psychological Distress and Enhancing Healthy Behaviors With Personalized Mobile Technology in Cardiac Patients: a Randomized Controlled-trial Study Protocol
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.
Read the 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
- Being tested
- Well-Being Therapy based on Web Mobile Technology, Cognitive Behavior Therapy, Standardized Care Management
- Keywords
- Psychological Distress, Depression, Anxiety, Well-Being Therapy, Heart Failure, Quality of Life, Adherence
- Medical subject headings
- Depression, Anxiety Disorders, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Well-Being Therapy based on Web Mobile TechnologyBehavioural
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 TherapyBehavioural
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 ManagementOther
CM will consist of reviewing the patients' clinical status, and providing the patient with support and advice if necessary.
| Study group | Role | What they receive |
|---|---|---|
| WBT-WEB | Experimental | Well-Being Therapy based on Web Mobile technology Receives: Behavioral: Well-Being Therapy based on Web Mobile Technology |
| CBT | Active comparator | Cognitive Behavior Therapy Receives: Behavioral: Cognitive Behavior Therapy |
| CM | No intervention | Standardized Care Management Receives: Other: Standardized Care Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological distress
Depression, Anxiety, and well-being improvements (Psychological Distress Reduction)
Measured: Within one year after the treatment
Secondary outcomes (3)
Quality of Life
Quality of Life
Measured: Within one year after the treatment
Medical Adherence
Measured: Within one year after the treatment
Promotion of Healthy Lifestyle
Promotion of Healthy Lifestyle
Measured: Within one year after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2012 (estimated)
- Study startJan 2006
- Primary completionFeb 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergamo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angelo Compare, University of Bergamo
- Investigators
- Angelo Compare, Ph.D, Principal investigator, University of Bergamo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01543815
- Sponsor's protocol ID
- NCT00289921
- Other IDs
- 029399
- Acronym
- WELL-ME
- Status last verified
- Dec 2011
- First submitted
- 28 Feb 2012
- Last updated
- 6 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22943627
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Well-Being Therapy for Psychological Distress and Enhancing Healthy Behaviors With Personalized Mobile Technology in Cardiac Patients: a Randomized Controlled-trial Study Protocol
- ClinicalTrials.gov ID
- NCT01543815
- Acronym / sponsor ID
- WELL-ME / NCT00289921
- Conditions
- Psychological Distress
- Keywords
- Psychological Distress, Depression, Anxiety, Well-Being Therapy, Heart Failure, Quality of Life, Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University of BergamoUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Feb 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 5 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| WBT-WEB | Experimental | Behavioral: Well-Being Therapy based on Web Mobile TechnologyWell-Being Therapy based on Web Mobile technology |
| CBT | Active comparator | Behavioral: Cognitive Behavior TherapyCognitive Behavior Therapy |
| CM | No intervention | Other: Standardized Care ManagementStandardized Care Management |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Well-Being Therapy based on Web Mobile TechnologyThe 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. | Behavioural | WBT-WEB |
| Cognitive Behavior TherapyCBT 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. | Behavioural | CBT |
| Standardized Care ManagementCM will consist of reviewing the patients' clinical status, and providing the patient with support and advice if necessary. | Other | CM |
Primary outcome
Psychological distress
Time frame: Within one year after the treatment
Depression, Anxiety, and well-being improvements (Psychological Distress Reduction)
3 secondary outcomes
Quality of Life
Time frame: Within one year after the treatment
Medical Adherence
Time frame: Within one year after the treatment
Promotion of Healthy Lifestyle
Time frame: Within one year after the treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2012.
- Derived from this study: PubMed 22943627Compare 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angelo Compare, Ph.D principal investigator
University of Bergamo
Questions about this trial
What is this clinical trial studying?
A study testing Well-Being Therapy based on Web Mobile Technology, Cognitive Behavior Therapy and Standardized Care Management in people with Psychological Distress, run by University of Bergamo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological distress (time frame: Within one year after the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01543815, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2012.