Clinical trial NCT03691402: Evaluation of Metacognitive Training for Depression in Later Life (MCT-Silver)
Official title: A Randomized Controlled Trial Examining the Efficacy of Metacognitive Training for Depression in Later Life (MCT-Silver)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2018-10-01
Enrollment: 80
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will evaluate the efficacy of metacognitive training for depression in later life (MCT-Silver) vs. cognitive remediation (mybraintraining©) in reducing depressive symptoms among older adults.

Detailed description: The study examines the efficacy of Metacognitive Training for depression in later life (MCT-Silver). The study intends to investigate the extent to which MCT-Silver leads to a significant reduction in depressive symptoms compared to an active control group (mybraintraining©) (primary outcome: change in clinician-assessed depressive symptoms from t0 to t1 and t2). Secondary outcomes include change in self-reported depressive symptoms and dysfunctional (meta) cognitive beliefs, as well as quality of life, rumination, self-reported anxiety, attitudes toward aging and neuropsychological functioning from t0 to t1 and t2. The study design is a randomized-controlled trial with one intervention group and one active control group.

Eligibility criteria: Inclusion Criteria:

* Able to give informed consent
* age 60 years or older
* diagnosis of a single episode or recurrent major depressive disorder (MDD) or dysthymia (verified by the MINI)
* sufficient command of the German language
* willingness to participate in intervention over a period of 8 weeks (participants who do not attend the intervention will also be included in the analysis)
* Visual and auditory acuity adequate for neuropsychological testing and participation in group sessions

Exclusion Criteria:

* lifetime psychotic symptoms (i.e., hallucinations, delusions or mania)
* acute suicidal tendency
* intellectual disability (estimated IQ \< 70)
* dementia or other neurological illness

Primary outcomes:
measure: Hamilton Depression Rating Scale (HRSD-24)
timeFrame: Total Time Frame is 5 months. Outcome is assessed at two points: baseline to post-assessment (8 weeks) and baseline to follow-up (5 months)
Secondary outcomes:
measure: 16-item Quick Inventory for Depression (QIDS-C16)
timeFrame: Total Time Frame is 5 months. Outcome is assessed at two points: baseline to post-assessment (8 weeks) and baseline to follow-up (5 months)
measure: Beck Depression Inventory (BDI)
timeFrame: Total Time Frame is 5 months. Outcome is assessed at two points: baseline to post-assessment (8 weeks) and baseline to follow-up (5 months)
measure: Dysfunctional Attitudes Scale Form 18B (DAS-18B)
timeFrame: Total Time Frame is 5 months. Outcome is assessed at two points: baseline to post-assessment (8 weeks) and baseline to follow-up (5 months)
measure: Metacognitions Questionnaire (MCQ-30)
timeFrame: Total Time Frame is 5 months. Outcome is assessed at two points: baseline to post-assessment (8 weeks) and baseline to follow-up (5 months)
measure: Rosenberg Self-Esteem Scale
timeFrame: Total Time Frame is 5 months. Outcome is assessed at two points: baseline to post-assessment (8 weeks) and baseline to follow-up (5 months)
measure: Ruminative Responses Scale
timeFrame: Total Time Frame is 5 months. Outcome is assessed at two points: baseline to post-assessment (8 weeks) and baseline to follow-up (5 months)
measure: World Health Organization Quality of Life-BREF - Item 1
timeFrame: Total Time Frame is 5 months. Outcome is assessed at two points: baseline to post-assessment (8 weeks) and baseline to follow-up (5 months)
measure: Remission rate
timeFrame: Total Time Frame is 5 months. Outcome is assessed at two points: baseline to post-assessment (8 weeks) and baseline to follow-up (5 months)
measure: EurQoL Group 5Q 5D 5L
timeFrame: Total Time Frame is 5 months. Outcome is assessed at two points: baseline to post-assessment (8 weeks) and baseline to follow-up (5 months)
measure: Trail-Making Test, Part B
timeFrame: Total Time Frame is 5 months. Outcome is assessed at two points: baseline to post-assessment (8 weeks) and baseline to follow-up (5 months)
measure: Trail-Making Test, Part A
timeFrame: Total Time Frame is 5 months. Outcome is assessed at two points: baseline to post-assessment (8 weeks) and baseline to follow-up (5 months)
measure: Rivermead Behavioral Memory Test
timeFrame: Total Time Frame is 5 months. Outcome is assessed at two points: baseline to post-assessment (8 weeks) and baseline to follow-up (5 months)
measure: Stroop Color-Word Task
timeFrame: Total Time Frame is 5 months. Outcome is assessed at two points: baseline to post-assessment (8 weeks) and baseline to follow-up (5 months)
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: Universtitätsklinikum Hamburg-Eppendorf
name: Steffen Moritz, PhD
role: PRINCIPAL_INVESTIGATOR
References: