Condition category
Circulatory System
Date applied
30/03/2007
Date assigned
30/05/2007
Last edited
30/05/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.bmbf.de/en/index.php

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

Publication citations

Additional files

Editorial Notes