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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00012317 |
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Date of registration:
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06/09/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Treating Prolonged Grief Disorder with Prolonged Grief-Specific Cognitive Behavioral Therapy: A Multicenter Parallel Group Randomized Controlled Trial
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Scientific title:
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Treating Prolonged Grief Disorder with Prolonged Grief-Specific Cognitive Behavioral Therapy: A Multicenter Parallel Group Randomized Controlled Trial
- PROGRID |
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Date of first enrolment:
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26/10/2017 |
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Target sample size:
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204 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00012317 |
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Study type:
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interventional |
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Study design:
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Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: active; Assignment: parallel; Study design purpose: treatment
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Phase:
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N/A
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Countries of recruitment
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Germany
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Contacts
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Name:
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Anna-Maria
Rummel |
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Address:
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Levelingstr. 7
85049
Ingolstadt
Germany |
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Telephone:
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+49 0841 937 - 21622 |
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Email:
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Anna-Maria.Rummel@ku.de |
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Affiliation:
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Katholische Universität Eichstätt-Ingolstadt, Lehrstuhl für Klinische und Biologische Psychologie |
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Name:
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Rita
Rosner |
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Address:
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Ostenstr. 25
85072
Eichstätt
Germany |
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Telephone:
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+49 8421 93 - 21581 |
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Email:
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rita.rosner@ku.de |
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Affiliation:
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Katholische Universität Eichstätt-Ingolstadt;
Lehrstuhl Klinische und Biologische Psychologie |
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Key inclusion & exclusion criteria
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Inclusion criteria: - primary diagnosis of prolonged grief disorder (PGD) as assessed in the PG-13 interview (Prigerson, Horowitz, Jacobs et al., 2009; German version: Rosner, Pfoh & Kotoucová, 2015)
- sufficient cognitive skills
- sufficient German language skills
- informed consent
Exclusion criteria: - current psychotic disorder
- severe substance use disorder
- acute suicidality
- ongoing psychotherapy
- treatment regime for antidepressant medication not yet stable for four weeks
- continuous treatment with benzodiazepines, antipsychotics, or opioids
- participation in another treatment trial
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Prolonged grief disorder (PGD) – expected to be included in ICD-11 (see beta version: http://bit.ly/1GoZamZ)
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Intervention(s)
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Group 1: 20 to 24 individual sessions of integrative cognitive behavioral therapy for prolonged grief (PG-CBT; Pfoh, Kotoucová & Rosner, 2015). Sessions are scheduled weekly whenever possible, a session lasting 50 minutes, although some sessions can be combined (100 min). The overall length of treatment is about 6 months.
Group 2: 20 to 24 individual sessions of present-centered therapy (PCT; Schnurr, Friedman, Foy et al., 2003; Shea, Bernardy, Howard, Key, & Lambert, 2003). Sessions are scheduled weekly whenever possible, a session lasting 50 minutes, although some sessions can be combined (100 min). The overall length of treatment is about 6 months.
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Primary Outcome(s)
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Severity of prolonged grief symptoms 12 months after randomization, measured with the German version (Rosner, Pfoh & Kotoucová, 2015) of the Interview for Prolonged Grief-13 (PG-13; Prigerson, Horowitz, Jacobs et al., 2009)
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Secondary Outcome(s)
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Post-treatment:
Prolonged grief symptom severity, measured with the German version (Rosner, Pfoh & Kotoucová, 2015) of the Interview for Prolonged Grief-13 (PG-13; Prigerson, Horowitz, Jacobs et al., 2009)
12 months after randomization and post-treatment:
• overall mental health, measured with the Global Severity Index (GSI) of the German version of the Brief Symptom Inventory (BSI; Franke, 2000)
• depressive symptoms, measured with the German revised version of the Beck Depression Inventory (BDI-II; Hautzinger, Keller, & Kühner, 2009)
• severity of somatoform symptoms according to the SOMS-7 (Rief & Hiller, 2008)
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Source(s) of Monetary Support
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Deutsche Forschungsgemeinschaft
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Ethics review
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Status: Approved
Approval date: 27/01/2017
Contact:
ethikkommission@ku.de
Ethikkommission der KU Eichstätt-Ingolstadt
+49 8421 93-21278
ethikkommission@ku.de
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