German Evaluation of the Effectiveness of the Psychological Intervention Managing Cancer and Living Meaningfully (CALM)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02051660|
Recruitment Status : Recruiting
First Posted : January 31, 2014
Last Update Posted : October 26, 2016
|Condition or disease||Intervention/treatment||Phase|
|Depression Psychological Distress||Behavioral: Manualized CALM intervention Behavioral: Non-manualized supportive intervention.||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||262 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||German Randomized Controlled Trial of the Psychotherapeutic Intervention for Advanced Cancer Patients: Managing Cancer and Living Meaningfully (CALM)|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||June 2017|
|Experimental: Manualized CALM Intervention||
Behavioral: Manualized CALM intervention
Managing Cancer and Living Meaning Cancer (CALM) is a short-term individual psychotherapy for patients with advanced disease.
Other Name: Managing Cancer and Living Meaning Cancer (CALM)
|Active Comparator: Non-manualized supportive intervention||
Behavioral: Non-manualized supportive intervention.
Supportive psycho-oncological intervention.
- Depression module of the Patient Health Questionnaire (PHQ-9) [ Time Frame: 6-months ]A reliable and valid 9-item measure of depression.
- Beck Depression-Inventory II (BDI-II) [ Time Frame: 6-months ]A reliable and valid 21-item self-report instrument for evaluating the severity of depression.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02051660
|Contact: Anja Mehnert, PhD||++49 (0)email@example.com|
|Contact: Martin Härter, PhD, MD||++49 (0)firstname.lastname@example.org|
|Department of Medical Psychology and Medical Sociology, University Medical Center Leipzig||Recruiting|
|Leipzig, Saxony, Germany, 04103|
|Contact: Dorit Engelmann, Dipl-Psych ++49 (0)341 - 9715458 email@example.com|
|Principal Investigator: Anja Mehnert, PhD|
|Department of Medical Psychology, University Medical Center Hamburg-Eppendorf||Recruiting|
|Hamburg, Germany, 20246|
|Contact: Katharina Scheffold, Msc ++49 (0)40 7410-56203 firstname.lastname@example.org|
|Principal Investigator: Martin Härter, PhD, MD|
|Principal Investigator:||Anja Mehnert, Prof Dr||University Medical Center of Leipzig|
|Principal Investigator:||Martin Härter, Prof Dr Dr||Universitätsklinikum Hamburg-Eppendorf|