Clinical trial NCT03011216: 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
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Rumination - Thoughts
Lead sponsor: Freie Universität Berlin
Sponsor class: OTHER
Collaborators: name: University of Stuttgart
name: University Ghent
First posted: 2017-01-05
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in rumination frequency in daily life
timeFrame: 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
measure: Change in the impact of daily rumination on daily mood
timeFrame: 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:
measure: Change in the ability to update emotional material in working memory
timeFrame: from pre-training to post-training (within a week after the end of the training phase)
measure: Change in depressed mood and depressive symptoms
timeFrame: 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
measure: Change in levels of disability
timeFrame: from pre-training to post-training (within a week after the end of the training phase)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Freie Universität Berlin
Study officials:
affiliation: Freie Universität Berlin
name: Ulrike Zetsche, Dr.
role: PRINCIPAL_INVESTIGATOR
References: