Effects of Online Cognitive Control Training on Rumination and Depressive Symptoms

NCT03011216 | Completed

• 1 other identifier: ZE 1029/3-1
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Rumination - Thoughts

Outcome Measures

Primary Outcomes (2)

• 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

  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

  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 Outcomes (3)

• Change in the ability to update emotional material in working memory

  from pre-training to post-training (within a week after the end of the training phase)

• Change in depressed mood and depressive symptoms

  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

  from pre-training to post-training (within a week after the end of the training phase)

Study Arms (2)

Adaptive emotional cognitive control training

EXPERIMENTAL

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

Placebo training

ACTIVE COMPARATOR

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

Interventions

Adaptive emotional cognitive control training BEHAVIORAL

Is supposed to train ability to continuously update emotional material in working memory.

Adaptive emotional cognitive control training

Adaptive non-emotional feature match task BEHAVIORAL

Does not train updating of working memory content; may train reaction time speed, visual search, or concentration abilities.

Placebo training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) criteria for a current major depressive episode
• years of age
• German native language (due to verbal task requirements)

You may not qualify if:

• 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

Sponsors & Collaborators

• Freie Universität Berlin: lead
• University of Stuttgart: collaborator
• University Ghent: collaborator

Study Sites (1)

Freie Universität Berlin

Berlin, 14195, Germany

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Ulrike Zetsche, Dr.

  Freie Universität Berlin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. rer. nat.

Study Record Dates

• First Submitted: December 19, 2016
• First Posted: January 5, 2017
• Study Start: July 1, 2018
• Primary Completion: September 1, 2020
• Study Completion: February 1, 2021
• Last Updated: August 1, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• 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.
• 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.

Locations

DE (1)