Plain English Summary
Not provided at time of registration
Trial website
http://www.klinikum.uni-heidelberg.de/HELPS.105744.0.html#c36863
Contact information
Type
Scientific
Primary contact
Prof Wolfgang Herzog
ORCID ID
Contact details
Department of Psychosomatic and General Internal Medicine
Medical Hospital
University of Heidelberg
INF 410
Heidelberg
69120
Germany
Wolfgang.Herzog@med.uni-heidelberg.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PINDET-HF - 01GI0205/21
Study information
Scientific title
Acronym
PINDET-HF
Study hypothesis
Psychotherapeutic treatment in patients with chronic heart failure and comorbid depression leads to a significant reduction of depression severity in comparison to usual care.
Ethics approval
Ethical approval for the study was obtained from the institutional review board of the medical faculty of the University of Heidelberg on the 5th March 2007 (ref.: 302/2006)
Study design
Randomised controlled intervention trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Chronic heart failure, depression
Intervention
Eight sessions in a psychotherapy group (six to nine patients per group), 90 minutes each, over three months, versus care as usual (patients are informed about depression diagnosis and are motivated to talk about treatment options with their GP). Psychotherapy is based on cognitive behavioural techniques and follows a manual. Elements of therapy are:
1. Psychoeducation
2. Cognitive techniques
3. Setup of positive activities
4. Relaxation skills
5. Keeping a study diary
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Depression severity according to PHQ-9 summary score at the end of the intervention.
Secondary outcome measures
1. PHQ-9 summary score three months after the intervention
2. Generic (36-item Short Form health survey [SF-36]) and disease-specific (Kansas City Cardiomyopathy Questionnaire [KCCQ]) quality of life
3. Anxiety severity (7-item Generalised Anxiety Disorder scale [GAD-7])
4. Resilience (Resilience Scale)
5. Hopelessness
6. Vital exhaustion
7. Self-reported adherence to heart failure self-management
Overall trial start date
01/01/2007
Overall trial end date
31/05/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Outpatients with documented, stable chronic heart failure
2. New York Heart Association (NYHA) functional class I to III
3. Any depressive disorder or major depressive disorder according to 9-item Patient Health Questionnaire (PHQ-9) AND dysthymia or adjustment disorder or major depressive disorder with mild or medium severity according to Structured Clinical Interview for Depression Interview (SCID-I)
4. Age equal or greater than 18 years
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
130
Participant exclusion criteria
1. Acute physical illness that makes participation impossible, according to investigator's assessment
2. Participation in other clinical intervention trial
3. Dementia or other psychiatric disorder, that compromise patients' abilities to study compliance
4. Alcohol or drug abuse
5. Severe major depressive disorder
6. Acute suicidal tendency
7. Current psychotherapeutic treatment
Recruitment start date
01/01/2007
Recruitment end date
31/05/2008
Locations
Countries of recruitment
Germany
Trial participating centre
Department of Psychosomatic and General Internal Medicine
Heidelberg
69120
Germany
Sponsor information
Organisation
German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany)
Sponsor details
Hannoversche Str. 28-30
Berlin
10115
Germany
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany) (ref: 01GI0205/21)
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
Results - basic reporting
Publication summary