search
Back to results

Effects of Online Cognitive Control Training on Rumination and Depressive Symptoms

Primary Purpose

Depression, Rumination - Thoughts

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Adaptive emotional cognitive control training
Adaptive non-emotional feature match task
Sponsored by
Freie Universität Berlin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Freie Universität Berlin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Adaptive emotional cognitive control training

Placebo training

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in rumination frequency in daily life
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
Change in the impact of daily rumination on daily mood
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.

Secondary Outcome Measures

Change in the ability to update emotional material in working memory
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.
Change in depressed mood and depressive symptoms
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.
Change in levels of disability
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)

Full Information

First Posted
December 19, 2016
Last Updated
July 27, 2022
Sponsor
Freie Universität Berlin
Collaborators
University of Stuttgart, University Ghent
search

1. Study Identification

Unique Protocol Identification Number
NCT03011216
Brief Title
Effects of Online Cognitive Control Training on Rumination and Depressive Symptoms
Official Title
"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 Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
February 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Freie Universität Berlin
Collaborators
University of Stuttgart, University Ghent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Rumination - Thoughts

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adaptive emotional cognitive control training
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo training
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Adaptive emotional cognitive control training
Intervention Description
Is supposed to train ability to continuously update emotional material in working memory.
Intervention Type
Behavioral
Intervention Name(s)
Adaptive non-emotional feature match task
Intervention Description
Does not train updating of working memory content; may train reaction time speed, visual search, or concentration abilities.
Primary Outcome Measure Information:
Title
Change in rumination frequency in daily life
Description
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
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
Title
Change in the impact of daily rumination on daily mood
Description
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.
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
Secondary Outcome Measure Information:
Title
Change in the ability to update emotional material in working memory
Description
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.
Time Frame
from pre-training to post-training (within a week after the end of the training phase)
Title
Change in depressed mood and depressive symptoms
Description
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.
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
Title
Change in levels of disability
Description
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)
Time Frame
from pre-training to post-training (within a week after the end of the training phase)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrike Zetsche, Dr.
Organizational Affiliation
Freie Universität Berlin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Freie Universität Berlin
City
Berlin
ZIP/Postal Code
14195
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Effects of Online Cognitive Control Training on Rumination and Depressive Symptoms

We'll reach out to this number within 24 hrs