ISRCTN - ISRCTN45945396: The InterHerz project - a web-based psychological treatment for cardiac patients with depression

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

https://www.online-therapy.ch/interherz/home.php

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 measures

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

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