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ISRCTN
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ISRCTN74936396
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ClinicalTrials.gov identifier
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Public title
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Psychotherapeutic INtervention for DEpression Treatment in patients with chronic Heart Failure
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Scientific title
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Acronym
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PINDET-HF
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Serial number at source
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PINDET-HF - 01GI0205/21
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Study hypothesis
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Psychotherapeutic treatment in patients with chronic heart failure and comorbid depression leads to a significant reduction of depression severity in comparison to usual care.
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Ethics approval
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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)
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Study design
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Randomised controlled intervention trial
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Countries of recruitment
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Germany
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Disease/condition/study domain
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Chronic heart failure, depression
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/01/2007
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Anticipated end date
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31/05/2008
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Status of trial
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Completed
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Patient information material
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Target number of participants
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130
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Interventions
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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
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Primary outcome measure(s)
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Depression severity according to PHQ-9 summary score at the end of the intervention.
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Secondary outcome measure(s)
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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
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Sources of funding
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German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany) (ref: 01GI0205/21)
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Trial website
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http://www.klinikum.uni-heidelberg.de/HELPS.105744.0.html#c36863
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Publications
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Contact name
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Prof
Wolfgang
Herzog
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Address
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Department of Psychosomatic and General Internal Medicine
Medical Hospital
University of Heidelberg
INF 410
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City/town
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Heidelberg
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Zip/Postcode
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69120
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Country
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Germany
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Email
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Wolfgang.Herzog@med.uni-heidelberg.de
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Sponsor
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German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany)
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Address
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Hannoversche Str. 28-30
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City/town
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Berlin
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Zip/Postcode
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10115
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Country
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Germany
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Sponsor website:
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http://www.bmbf.de/en/index.php
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Date applied
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30/03/2007
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Last edited
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30/05/2007
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Date ISRCTN assigned
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30/05/2007
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