Psychotherapeutic INtervention for DEpression Treatment in patients with chronic Heart Failure

ISRCTN	ISRCTN74936396
DOI	https://doi.org/10.1186/ISRCTN74936396
Secondary identifying numbers	PINDET-HF - 01GI0205/21

Submission date: 30/03/2007
Registration date: 30/05/2007
Last edited: 19/10/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Prof Wolfgang Herzog
Scientific

Department of Psychosomatic and General Internal Medicine
Medical Hospital
University of Heidelberg
INF 410
Heidelberg
69120
Germany

Email	Wolfgang.Herzog@med.uni-heidelberg.de

Study information

Study design	Randomised controlled intervention trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Psychotherapeutic INtervention for DEpression Treatment in patients with chronic Heart Failure
Study acronym	PINDET-HF
Study objectives	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(s)	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)
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/01/2007
Completion date	31/05/2008

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	130
Key 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
Key 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
Date of first enrolment	01/01/2007
Date of final enrolment	31/05/2008

Locations

Countries of recruitment

Germany

Study participating centre

Department of Psychosomatic and General Internal Medicine

Heidelberg
69120
Germany

Sponsor information

German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany)
Government

Hannoversche Str. 28-30
Berlin
10115
Germany

Website	http://www.bmbf.de/en/index.php
"ROR"	https://ror.org/04pz7b180

Funders

Funder type

Government

German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany) (ref: 01GI0205/21)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

19/10/2021: Proactive update review. No publications found. Search options exhausted.