NCT03548519

Brief Summary

This study evaluates the effectiveness of a smartphone-delivered attention control training as a preventive intervention for remitted depressed patients. Additionally, the investigators aim to increase the effect of this CBM-intervention by adding a psychoeducation module (CBT-intervention). To test this aim, participants will be randomly assigned to one of three conditions: (1) an experimental training condition with prior psychoeducation, (2) an experimental training condition without prior psychoeducation, or (3) a placebo training condition serving as an active control condition.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 7, 2018

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 7, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

November 10, 2022

Status Verified

November 1, 2022

Enrollment Period

3.6 years

First QC Date

May 15, 2018

Last Update Submit

November 7, 2022

Conditions

Major Depression in Remission

Outcome Measures

Primary Outcomes (2)

  • Change in depression, anxiety, and stress

    Measured by the 21-item version of the Depression, Anxiety, and Stress Scales (DASS-21)

    Pre-test, Post-test (immediately after the two week intervention period), Follow-up (3 and 6 months)

  • Change in rumination

    Measured by the Ruminative Response Scale (RRS). This 22-item questionnaire provides a total rumination score (range: 22 - 88), as well as Brooding and Reflection subscale scores (range: 5 - 20). Brooding is characterized by a passive style of moody pondering and is the most maladaptive form of depressive rumination. Higher scores indicate a worse outcome.

    Pre-test, Post-test (immediately after the two week intervention period), Follow-up (3 and 6 months)

Secondary Outcomes (10)

  • Change in attentional bias

    Pre-test, Post-test (immediately after the two week intervention period)

  • Change in reappraisal

    Pre-test, Post-test (immediately after the two week intervention period)

  • Change in negative emotions (after reappraisal)

    Pre-test, Post-test (immediately after the two week intervention period)

  • Change in (mal-)adaptive cognitive emotion regulation strategies

    Pre-test, Post-test (immediately after the two week intervention period), Follow-up (3 and 6 months)

  • Change in maladaptive cognitive emotion regulation strategies: State rumination

    Pre-test, Post-test (immediately after the two week intervention period), Follow-up (3 and 6 months)

  • +5 more secondary outcomes

Other Outcomes (1)

  • User engagement

    Post-test (immediately after the two week intervention period)

Study Arms (3)

Attention Training

EXPERIMENTAL

OCAT-only: An attention training, consisting of 10 sessions of ±12 minutes each (during an intervention period of two weeks), will be administered. The training task is a positively directed Scrambled Sentences Test (SST) with mouse-gaze contingent feedback.

Behavioral: OCAT-only

Active placebo training

ACTIVE COMPARATOR

OCAT-sham: An active placebo training, consisting of 10 sessions of ±12 minutes each (during an intervention period of two weeks), will be administered. The training task is an undirected Scrambled Sentences Test (SST) with mouse-gaze contingent feedback.

Behavioral: OCAT-sham

PSE and Attention Training

EXPERIMENTAL

OCAT-combo: An online PSE session prior to an attention training, consisting of 10 sessions of ±12 minutes each (during an intervention period of two weeks), will be administered. Content of the PSE will focus on how adaptive functions of automatic and controlled processes may become maladaptive when used inappropriately or excessively. The training task is a positively directed Scrambled Sentences Test (SST) with mouse-gaze contingent feedback.

Behavioral: OCAT-combo

Interventions

OCAT-onlyBEHAVIORAL

online-contingent Attention Training without prior psychoeducation

Attention Training
OCAT-shamBEHAVIORAL

Placebo version of Online contingent Attention Training without prior psychoeducation

Active placebo training
OCAT-comboBEHAVIORAL

Online contingent Attention Training with prior psychoeducation

PSE and Attention Training

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • History of ≥ 1 depressive episodes (major or bipolar)
  • Currently in stable full or partial remission (≥ 3 months)
  • Being in possession of a recent computer (needed to install the training software)

You may not qualify if:

  • Major depressive disorder (current or less than 3 months in remission)
  • Bipolar disorder (current or less than 3 months in remission)
  • Psychotic disorder (current and/or previous)
  • Neurological impairments (current and/or previous)
  • Excessive substance abuse (current and/or previous)
  • Ongoing psychotherapeutic treatment (maintenance treatment is allowed, but with a frequency of less than once every three weeks)
  • Use of antidepressant medication is allowed if kept at a constant level
  • Not being in possession of a recent computer (needed to install the training software)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Related Publications (2)

  • Sanchez A, Everaert J, Koster EH. Attention training through gaze-contingent feedback: Effects on reappraisal and negative emotions. Emotion. 2016 Oct;16(7):1074-85. doi: 10.1037/emo0000198. Epub 2016 Jun 20.

    PMID: 27322115BACKGROUND

  • Vanderhasselt MA, De Raedt R, De Paepe A, Aarts K, Otte G, Van Dorpe J, Pourtois G. Abnormal proactive and reactive cognitive control during conflict processing in major depression. J Abnorm Psychol. 2014 Feb;123(1):68-80. doi: 10.1037/a0035816.

    PMID: 24661161BACKGROUND

Study Officials

  • Ernst Koster

    University Ghent

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2018

First Posted

June 7, 2018

Study Start

May 7, 2018

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

November 10, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)