Universität zu Köln

Dafsari, Forugh S., Bewernick, Bettina, Biewer, Matthias, Christ, Hildegard ORCID: 0000-0003-3235-2994, Domschke, Katharina, Froelich, Lutz, Hellmich, Martin, Luppa, Melanie, Peters, Oliver, Ramirez, Alfredo ORCID: 0000-0003-4991-763X, Riedel-Heller, Steffi, Schramm, Elisabeth, Vry, Magnus-Sebastian, Wagner, Michael, Hautzinger, Martin and Jessen, Frank (2019). Cognitive behavioural therapy for the treatment of late life depression: study protocol of a multicentre, randomized, observer-blinded, controlled trial (CBTlate). BMC Psychiatry, 19 (1). LONDON: BMC. ISSN 1471-244X

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Abstract

BackgroundLate-life depression (LLD) is one of the most prevalent mental disorders in old age. It is associated with various adverse outcomes and frequent use of health care services thereby remaining a serious public health concern. Compared with depression in early adulthood, most treatment options of LLD are less effective. Psychotherapy may be particularly beneficial for LLD due to specific psychological conditions in old age and a low risk of side effects. Although cognitive behavioural therapy (CBT) is highly established and effective in depression in young and mid-life there is only a limited number of small studies on CBT in LLD. An LLD-specific CBT has not yet been compared to an active, but unspecific supportive psychological intervention in a multicentre trial.MethodsHere we present the design of the CBTlate trial, which is a multicentre, randomized, observer-blinded, active-controlled, parallel group trial. CBTlate aims at including 248 patients with LLD of both genders at 7 sites in Germany. The purpose of the study is to test the hypothesis that a 15-session individually-delivered CBT specific for LLD is of superior efficacy in reducing symptoms of depression in comparison with a supportive unspecific intervention (SUI) of the same quantity. The intervention includes 8weeks of individual treatment sessions twice per week and a follow-up period of 6months after randomization. The primary end point is the severity of depression at the end of treatment measured by the self-rated 30-item Geriatric Depression Scale (GDS). Secondary endpoints include depressive symptoms at week 5 and at follow-up (6months after randomization). Additional secondary endpoints include the change of depressive symptoms assessed with a clinician-rating-scale and a patient reported outcome instrument for major depressive disorder, anxiety symptoms, sleep, cognition, quality of life, and overall health status from baseline to end-of treatment and to end of follow-up. Add-on protocols include MRI and the collection of blood samples.DiscussionThis study is the first multicentre trial of a specific CBT intervention for LLD compared to an unspecific supportive psychological intervention administered in a specialist setting. It has important implications for developing and implementing efficient psychotherapeutic strategies for LLD and may be a significant step to broaden treatment options for people suffering from LLD.Trial registrationClinicalTrials.gov (NCT03735576, registered on 24 October 2018); DRKS (DRKS00013769, registered on 28 June 2018).

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Dafsari, Forugh S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Bewernick, Bettina UNSPECIFIED UNSPECIFIED UNSPECIFIED Biewer, Matthias UNSPECIFIED UNSPECIFIED UNSPECIFIED Christ, Hildegard UNSPECIFIED orcid.org/0000-0003-3235-2994 UNSPECIFIED Domschke, Katharina UNSPECIFIED UNSPECIFIED UNSPECIFIED Froelich, Lutz UNSPECIFIED UNSPECIFIED UNSPECIFIED Hellmich, Martin UNSPECIFIED UNSPECIFIED UNSPECIFIED Luppa, Melanie UNSPECIFIED UNSPECIFIED UNSPECIFIED Peters, Oliver UNSPECIFIED UNSPECIFIED UNSPECIFIED Ramirez, Alfredo UNSPECIFIED orcid.org/0000-0003-4991-763X UNSPECIFIED Riedel-Heller, Steffi UNSPECIFIED UNSPECIFIED UNSPECIFIED Schramm, Elisabeth UNSPECIFIED UNSPECIFIED UNSPECIFIED Vry, Magnus-Sebastian UNSPECIFIED UNSPECIFIED UNSPECIFIED Wagner, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED Hautzinger, Martin UNSPECIFIED UNSPECIFIED UNSPECIFIED Jessen, Frank UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-123906
DOI:	10.1186/s12888-019-2412-0
Journal or Publication Title:	BMC Psychiatry
Volume:	19
Number:	1
Date:	2019
Publisher:	BMC
Place of Publication:	LONDON
ISSN:	1471-244X
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language NEUROPSYCHIATRIC INTERVIEW MINI; NEUROPSYCHOLOGICAL ASSESSMENT BATTERY; INSOMNIA SEVERITY INDEX; ALZHEIMERS-DISEASE; OLDER-PEOPLE; SYMPTOMATOLOGY IDS; VALIDATION; SYMPTOMS; METAANALYSIS; INVENTORY Multiple languages Psychiatry Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/12390