- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03011216
Effects of Online Cognitive Control Training on Rumination and Depressive Symptoms
"Ein Training Kognitiver Kontrolle Emotionaler Inhalte im Arbeitsgedächtnis: Effekte Auf Die Häufigkeit Und Auswirkungen Von Grübeln Bei Depressiven Patienten" (English: Training Cognitive Control Over Emotional Information in Working Memory: Effects on the Frequency of Rumination and Its Impact on Mood in the Daily Lives of Depressed Patients)
Study Overview
Status
Conditions
Detailed Description
Rumination has been shown to intensify dysphoric mood and is one of the best researched risk factors for the onset and recurrence of depressive episodes. Accumulating evidence suggests that the tendency to ruminate is linked to impairments in cognitive control functions, especially to problems discarding no longer relevant negative material from working memory (=working memory updating).
The aim of the present study is to examine whether training to update emotional material in working memory will have an effect on the frequency of using rumination as well as on the impact of rumination on mood in the daily lives of clinically depressed participants. Participants will be randomly assigned to 10 sessions of either online cognitive control training or an online placebo condition. The ability to update emotional material in working memory will be assessed pre and post training by two computer tasks (close and far transfer tasks). The effects of the training on daily rumination and the dynamics between daily mood and rumination will be assessed pre- and post-training, as well as at 3-months follow-up using ambulatory assessment (via smartphone app). It is expected that individuals in the training as compared to the placebo group will show a greater reduction in rumination frequency as well as a reduction in the negative impact of rumination on mood.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Berlin, Germany, 14195
- Freie Universität Berlin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) criteria for a current major depressive episode
- 18-65 years of age
- German native language (due to verbal task requirements)
Exclusion Criteria:
- life time diagnosis of any bipolar or psychotic disorder, or substance dependence
- substance use disorder within past 12 months
- current obsessive-compulsive disorder (OCD) or borderline personality disorder (BPS)
- reporting severe underweight (BMI<18), any neurological disease, severe head injury (e.g. severe concussion), or any brain damage (e.g. due to stroke)
- concurrent psychotherapy during the duration of the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Adaptive emotional cognitive control training
Adaptive emotional n-back task: On each trial of this task, participants are presented with an emotional facial expression. Participants have to indicate whether the emotion presented in the current trial is the same as n trials back. In order to train participants at their individual ability level, the n-level varies by trial block based on participants' performance on the previous block. The adaptive emotional n-back task is assumed to train the ability to continuously update emotional material in working memory. |
Is supposed to train ability to continuously update emotional material in working memory.
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Active Comparator: Placebo training
Adaptive non-emotional feature match task: On each trial of this task, participants are presented with two panels containing 8-12 shapes each. Participants are asked to compare the two panels and decide whether or not they are identical. The panels contain a minimum of 8 shapes and a maximum of 12 shapes, depending on participants' performance on the previous block. The adaptive non-emotional feature match task is assumed to train the speed of responding (involving processes like visual search and concentration). It does not trait working memory updating. |
Does not train updating of working memory content; may train reaction time speed, visual search, or concentration abilities.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in rumination frequency in daily life
Time Frame: from 7-day assessment at pre-training (baseline) to (a) 7-day assessment at post-training (within a week after the end of the training phase), and (b) 7-day assessment at 3-months follow-up
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Rumination frequency is measured by 2 items in the ambulatory assessment.
The ambulatory assessment is employed for 7 days pre-training, 7 days post-training (within a week after the end of the training phase), and 7 days at 3-months follow-up with 8 prompts per day during each assessment period
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from 7-day assessment at pre-training (baseline) to (a) 7-day assessment at post-training (within a week after the end of the training phase), and (b) 7-day assessment at 3-months follow-up
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Change in the impact of daily rumination on daily mood
Time Frame: from 7-day assessment at pre-training (baseline) to (a) 7-day assessment at post-training (within a week after the end of the training phase), and (b) 7-day assessment at 3-months follow-up
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The impact of rumination on mood is assessed as the effect of rumination at time t on depressed and positive mood at time t+1 in a multi level model; Time t refers to consecutive assessment points in the ambulatory assessment.
The ambulatory assessment is employed for 7 days pre-training, 7 days post-training (within a week after the end of the training phase), and 7 days at 3-months follow-up with 8 prompts per day during each assessment period.
Rumination frequency is assessed by two items; depressed and positive mood are each assessed by the average score of two items.
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from 7-day assessment at pre-training (baseline) to (a) 7-day assessment at post-training (within a week after the end of the training phase), and (b) 7-day assessment at 3-months follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the ability to update emotional material in working memory
Time Frame: from pre-training to post-training (within a week after the end of the training phase)
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Manipulation Check: Measured by two computer tasks (non-adaptive n-back task; modified Sternberg task) in the lab sessions pre- and post-training (=within a week after the end of the training phase).
Dependent variables are the differences in accuracy rates and reaction times between the experimental and the control condition in these tasks.
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from pre-training to post-training (within a week after the end of the training phase)
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Change in depressed mood and depressive symptoms
Time Frame: from 7-day assessment at pre-training (baseline) to (a) 7-day assessment at post-training (within a week after the end of the training phase), and (b) 7-day assessment at 3-months follow-up
|
Depressed mood is assessed by the average score of 2 items in the ambulatory assessment. Ambulatory assessment is employed for 7 days pre-training, 7 days post-training (within a week after the end of the training phase), and 7 days at 3-months follow-up with 8 prompts per day during each assessment period. Depressive symptoms are assessed by the Center for Epidemiological Studies - Depression Scale. |
from 7-day assessment at pre-training (baseline) to (a) 7-day assessment at post-training (within a week after the end of the training phase), and (b) 7-day assessment at 3-months follow-up
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Change in levels of disability
Time Frame: from pre-training to post-training (within a week after the end of the training phase)
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Level of disability is assessed by the sum score of the self-report version of the World Health Organization Disability Schedule 2.0 in the lab sessions pre- and post-training (=within 7 days after the end of the training phase)
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from pre-training to post-training (within a week after the end of the training phase)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ulrike Zetsche, Dr., Freie Universität Berlin
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZE 1029/3-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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