NCT02407652

Brief Summary

The purpose of this study is to explore the effectiveness of an internet-delivered cognitive control training as a preventive intervention for remitted depressed patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2015

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 3, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

December 17, 2015

Status Verified

December 1, 2015

Enrollment Period

10 months

First QC Date

March 10, 2015

Last Update Submit

December 16, 2015

Conditions

Major Depression in Remission

Outcome Measures

Primary Outcomes (2)

  • Change in depressive rumination from baseline to the post-training assessment and follow-up (RRS)

    Assessed using the Ruminative Response Scale (RRS)

    baseline, 2 weeks, 3 months

  • Change in depressive symptomatology from baseline to the post-training assessment and follow-up (BDI-II)

    Assessed using the Beck Depression Inventory (BDI-II)

    baseline, 2 weeks, 3 months

Secondary Outcomes (5)

  • (mal-)Adaptive cognitive emotion regulation (CERQ)

    baseline, 2 weeks, 3 months

  • Quality of Life (QLDS)

    baseline, 3 months

  • Disability (WHODAS 2.0)

    baseline, 3 months

  • Resilience (RS)

    baseline, 3 months

  • Remission from depression (RDQ)

    baseline, 3 months

Other Outcomes (2)

  • Behavioral measure for cognitive control ((non-adaptive) PASAT)

    baseline, 2 weeks, 3 months

  • Self-reported cognitive control (BRIEF-A)

    baseline, 2 weeks, 3 months

Study Arms (2)

cognitive control training

EXPERIMENTAL

internet-delivered, 2 weeks

Behavioral: Cognitive Control Training

low cognitive load training

ACTIVE COMPARATOR

internet-delivered, 2 weeks

Behavioral: Low Cognitive Load Training

Interventions

Cognitive Control TrainingBEHAVIORAL

10 adaptive Paced Auditory Serial Addition Task (PASAT) sessions, 400 trials each

cognitive control training
Low Cognitive Load TrainingBEHAVIORAL

10 low cognitive load sessions, 400 trials each

low cognitive load training

Eligibility Criteria

Age23 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • History of ≥ 1 depressive episode(s)
  • Currently in stable full or partial remission (≥ 6 months)

You may not qualify if:

  • Major depressive disorder (MDD; current)
  • Bipolar disorder (current and/or previous)
  • Psychotic disorder (current and/or previous)
  • Neurological impairments (current and/or previous)
  • Excessive substance abuse (current and/or previous)
  • No other comorbid disorders (current)
  • No ongoing psychotherapeutic treatment (maintenance treatment is allowed, but with a frequency less than once / 3 weeks)
  • Use of antidepressant medication is allowed if kept at a constant level

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Related Publications (2)

  • Hoorelbeke K, Koster EHW. Internet-delivered cognitive control training as a preventive intervention for remitted depressed patients: Evidence from a double-blind randomized controlled trial study. J Consult Clin Psychol. 2017 Feb;85(2):135-146. doi: 10.1037/ccp0000128. Epub 2016 Jun 30.

    PMID: 27362792DERIVED

  • Hoorelbeke K, Faelens L, Behiels J, Koster EH. Internet-delivered cognitive control training as a preventive intervention for remitted depressed patients: Protocol for a randomized controlled trial. BMC Psychiatry. 2015 Jun 9;15:125. doi: 10.1186/s12888-015-0511-0.

    PMID: 26055122DERIVED

Study Officials

  • Ernst Koster, PhD

    University Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2015

First Posted

April 3, 2015

Study Start

December 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

December 17, 2015

Record last verified: 2015-12

Locations

BE(1)