Effects of Online Cognitive Control Training on Rumination and Depressive Symptoms

July 27, 2022 updated by: Ulrike Zetsche, Freie Universität Berlin

"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)

The present study examines whether a computerized cognitive control training as compared to a placebo (fake) training will reduce the frequency of depressive rumination in depressed individuals. Rumination has been identified as a major risk factor for the onset and recurrence of depressive episodes and it has been suggested that it is linked to deficits in cognitive control functions. It is thus expected that training cognitive control will reduce the frequency of rumination as well as ameliorate its detrimental effect on negative mood states.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
65

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 14195
        • Freie Universität Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Adaptive emotional cognitive control training
Is supposed to train ability to continuously update emotional material in working memory.
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.
Behavioral: Adaptive non-emotional feature match task
Does not train updating of working memory content; may train reaction time speed, visual search, or concentration abilities.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
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
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
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
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.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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)
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.
from pre-training to post-training (within a week after the end of the training phase)
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
Change in levels of disability
Time Frame: from pre-training to post-training (within a week after the end of the training phase)
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)
from pre-training to post-training (within a week after the end of the training phase)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Freie Universität Berlin

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Ghent
University of Stuttgart

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ulrike Zetsche, Dr., Freie Universität Berlin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 5, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 1, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZE 1029/3-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-individualized data files will be uploaded on Open Science Framework (https://osf.io/) when publications are being prepared

IPD Sharing Time Frame

De-individualized data files and the analytic code for each publication will be uploaded on Open Science Framework (https://osf.io/) when the respective publication is prepared. The osf link will be made public as soon as the publication appears online.The data will be accessible as long as osf exists.

IPD Sharing Access Criteria

There are no access criteria for reading the code and data. However, if a researcher wants to use the data for further analyses, the researcher has to notify the authors and ask for permission.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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