Plain English Summary
Background and study aims
Patients with heart disease often suffer from depression. Depression is known to have a negative impact on the progression of heart disease. The aim of the study is to investigate whether depressed patients with a heart disease benefit from a web-based treatment called deprexis.
Who can participate?
To participate you must be 18 years old or older, diagnosed with a heart disease and feel depressed.
What does the study involve?
If you decide to participate in the study, you will be randomly assigned to one of two groups. Both groups receive access to the web-based treatment called deprexis but at different time points. One group can start with the web-based treatment immediately after giving their written informed consent, and the other group receives access after a waiting period of 10 weeks. The aim of the study is to compare these two groups. Therefore, all participants will be assessed at three different time points (before receiving access to the treatment, after 10 weeks and after 6 months). The assessments will involve a phone interview and a number of questionnaires.
What are the possible benefits and risks of participating?
The benefits of the study are a reduction of depressive symptoms. Previous research has shown that participants felt better and healthier after the treatment. There are no known negative side effects related to the treatment. However, it is unclear as to what extent depressed participants with a heart disease benefit from deprexis.
Where is the study run from?
University of Bern (Switzerland).
When is study starting and how long is it expected to run for?
The study has started in March 2012 and will continue to recruit participants until April 2014.
Who is funding the study?
University of Bern (Switzerland).
Who is the main contact?
Nadine Messerli-Bürgy, PhD
nadine.messerli@psy.unibe.ch
Trial website
Contact information
Type
Scientific
Primary contact
Dr Nadine Messerli-Bürgy
ORCID ID
Contact details
University of Bern
Dept. of Clinical Psychology and Psychotherapy
Gesellschaftsstrasse 49
Bern
3012
Switzerland
nadine.messerli@psy.unibe.ch
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The InterHerz project - a web-based psychological treatment for cardiac patients with depression: a randomized controlled trial
Acronym
InterHerz
Study hypothesis
The primary aim of the study is to investigate whether a web-based psychological treatment for cardiac patients with depression is effective to reduce depression and perceived stress. It is assumed that participants of the treatment group show lower depression levels and less perceived stress after the treatment compared with the wait-list control group. Further, we expect higher levels of perceived social support, and improved quality of life in the intervention group.
The secondary aim is to investigate a mid-term benefit of the psychological treatment at follow-up after six months. We hypothesize that all participants at six months compared with pre-treatment show reduced depression levels, reduced stress perception, improved perceived social support and improved quality of life.
Ethics approval
Faculty of Human Sciences Ethics Committee, University of Bern, 02/03/2011, ref: 2011-02-151
Study design
Randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Patients with cardiovascular diseases and depressive symptoms
Intervention
Comparing a web-based intervention with a waitlist-control condition
The intervention is a web-based psychological treatment called deprexis evaluated in previous trials. Deprexis was developed to reduce depressive symptoms in patients without any somatic disease. The program consists of 10 content modules. All modules can each be completed in 10 to 60 minutes, depending on the users reading speed, interest, motivation, and individual path through the program. The modules cover a variety of therapeutic content that is broadly consistent with a cognitive-behavioral perspective. Participants are guided by a clinical psychologist through their work with this self-help program.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Depression levels by BDI-II (Hautzinger et al., 2006), and clinical depression by the Patient Health Questionnaire (Gräfe et al., 2004) and by a clinical interview according to the Structured Clinical Interview for DSM Diagnosis SCID (APA, 2000).
Secondary outcome measures
1. Stress perception by Perceived Stress Questionnaire PSQ (Fliege et al., 2005)
2. Social support by the ENRICHD Social Support Inventory ESSI (Cordes et al., 2009)
3. Quality of life by the WHOQOL-BREF (Angermayer et al., 2000)
4. Health behavior#
5. Client satisfaction by the Client Satisfaction Questionnaire CSQ (Schmidt & Wittmann, 2002)
Overall trial start date
01/03/2012
Overall trial end date
01/04/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Adults who suffer from any cardiovascular disorder (including coronary heart disease, chronic heart failure, and arrhythmias)
2. Written informed consent
3. Are 18 years or older
4. Have symptoms of depression (as defined by scoring above a cut-off of 9 on the Beck Depression Inventory (BDI-II)
5. Are of sufficient knowledge of German language
6. Have access to the Internet
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
80 (n=40 participants per group)
Participant exclusion criteria
1. Any acute health threatening disease (e.g. cancer)
2. Any severe psychiatric illness (e.g. psychosis, dementia)
3. Suicidal thoughts or suicidal plans, or
4. A unstable heart condition
Recruitment start date
01/03/2012
Recruitment end date
01/04/2014
Locations
Countries of recruitment
Switzerland
Trial participating centre
University of Bern
Bern
3012
Switzerland
Sponsor information
Organisation
University of Bern (Switzerland)
Sponsor details
Dept. of Clinical Psychology and Psychotherapy
Gesellschaftsstrasse 49
Bern
3012
Switzerland
nadine.messerli@psy.unibe.ch
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Bern, Department of Clinical Psychology and Psychotherapy (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23273042
Publication citations
-
Protocol
Messerli-Bürgy N, Barth J, Berger T, The InterHerz project--a web-based psychological treatment for cardiac patients with depression: study protocol of a randomized controlled trial., Trials, 2012, 13, 245, doi: 10.1186/1745-6215-13-245.