NCT04006756

Brief Summary

This study evaluates the efficacy of an eight-week online cognitive training program on feasability and on objective and subjective cognitive functions in patients with late life mood disorders (LLMD). In the feasability study two training groups will be compared. The primary aim is to investigate feasability, measured by compliance attendance and satisfaction of the participants. The secondary aim is to study the possible effects of the intervention on cognitive functions. Additionally, effects on mood symptoms, social functioning, sense of mastery and quality of lide will be studied.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable depression

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

First Submitted

Initial submission to the registry

February 12, 2019

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

September 17, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2021

Completed
Last Updated

December 1, 2021

Status Verified

November 1, 2021

Enrollment Period

2.2 years

First QC Date

February 12, 2019

Last Update Submit

November 30, 2021

Conditions

DepressionLate Life Mood DisorderImpaired CognitionAlteration in MoodAlteration in Cognition

Outcome Measures

Primary Outcomes (2)

  • Feasability of the intervention measured via therapy compliance and drop-out

    therapy compliance, drop-out

    Eight weeks (T1)

  • Appreciation of the intervention

    Questionnaire on difficulty, feasability, joy, effort, challenge of the therapy, clearness of the intervention explanation, evaluation groups (mirror groups)

    Eight weeks (T1)

Secondary Outcomes (8)

  • Subjective cognitive functioning measured via the CFQ

    Eight weeks (T1) and 3 months (T2)

  • Genaral objective cognitive functioning via the MOCA

    Eight weeks (T1) and 3 months (T2)

  • Mood symptoms via MADRS

    Eight weeks (T1) and 3 months (T2)

  • Quality of life via the MANSA

    Eight weeks (T1) and 3 months (T2)

  • Sense of Mastery via Mastery questionnaire

    Eight weeks (T1) and 3 months (T2)

  • +3 more secondary outcomes

Other Outcomes (10)

  • Apathy via apathy scale

    Eight weeks (T1) and 3 months (T2)

  • Global cognitive dysfunction via the Pentagon Drawing Test

    Eight weeks (T1) and 3 months (T2)

  • Information processing speed and inhibition via the STROOP-test

    Eight weeks (T1) and 3 months (T2)

  • +7 more other outcomes

Study Arms (2)

Online cognitive training 1

EXPERIMENTAL

Eight-week, three times a week during 45 minutes cognitive training

Behavioral: Online cognitive training 1

Online cognitive training 2

ACTIVE COMPARATOR

Eight-week, three times a week during 45 minutes cognitive activities

Behavioral: Online cognitive training 2

Interventions

Online cognitive training 1BEHAVIORAL

Eight-week online cognitive training program, three times a week for 45 minutes. The training contains several games that are designed to train cognitive functions.

Online cognitive training 1
Online cognitive training 2BEHAVIORAL

Eight-week online active comparator program, three times a week for 45 minutes. The training contains several games.

Online cognitive training 2

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years and older
  • subjective cognitive complaints
  • early or partial remission of depressive episode with a diagnosis of unipolar recurrent depression (current episode is at least the third episode and shorter than 2 years) or bipolar disorder according to DSM 5 criteria.
  • have acces to internet on computer, tablet or lapyop
  • willing to sign informed consent

You may not qualify if:

  • current psychotic symptoms
  • severe suicidal ideations
  • severe personality disorder (as a main diagnosis)
  • severe alcohol or substance abuse
  • insufficient mastery of the Dutch language.
  • on 2 or more cognitive domains below 1 SD of the norm
  • moca \< 22

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GGZ inGeest

Amsterdam, North Holland, 1081 JC, Netherlands

Location

Related Publications (16)

  • Depp C, Vahia IV, Jeste D. Successful aging: focus on cognitive and emotional health. Annu Rev Clin Psychol. 2010;6:527-50. doi: 10.1146/annurev.clinpsy.121208.131449.

    PMID: 20192798BACKGROUND

  • Farrand P, Matthews J, Dickens C, Anderson M, Woodford J. Psychological interventions to improve psychological well-being in people with dementia or mild cognitive impairment: systematic review and meta-analysis protocol. BMJ Open. 2016 Jan 27;6(1):e009713. doi: 10.1136/bmjopen-2015-009713.

    PMID: 26817638BACKGROUND

  • Harris Y, Cooper JK. Depressive symptoms in older people predict nursing home admission. J Am Geriatr Soc. 2006 Apr;54(4):593-7. doi: 10.1111/j.1532-5415.2006.00687.x.

    PMID: 16686868BACKGROUND

  • Korten NC, Penninx BW, Kok RM, Stek ML, Oude Voshaar RC, Deeg DJ, Comijs HC. Heterogeneity of late-life depression: relationship with cognitive functioning. Int Psychogeriatr. 2014 Jun;26(6):953-63. doi: 10.1017/S1041610214000155. Epub 2014 Feb 24.

    PMID: 24565278BACKGROUND

  • Kuiper JS, Zuidersma M, Zuidema SU, Burgerhof JG, Stolk RP, Oude Voshaar RC, Smidt N. Social relationships and cognitive decline: a systematic review and meta-analysis of longitudinal cohort studies. Int J Epidemiol. 2016 Aug;45(4):1169-1206. doi: 10.1093/ije/dyw089. Epub 2016 Jun 6.

    PMID: 27272181BACKGROUND

  • Motter JN, Pimontel MA, Rindskopf D, Devanand DP, Doraiswamy PM, Sneed JR. Computerized cognitive training and functional recovery in major depressive disorder: A meta-analysis. J Affect Disord. 2016 Jan 1;189:184-91. doi: 10.1016/j.jad.2015.09.022. Epub 2015 Sep 26.

    PMID: 26437233BACKGROUND

  • Preiss M, Shatil E, Cermakova R, Cimermanova D, Ram I. Personalized cognitive training in unipolar and bipolar disorder: a study of cognitive functioning. Front Hum Neurosci. 2013 May 13;7:108. doi: 10.3389/fnhum.2013.00108. eCollection 2013.

    PMID: 23717272BACKGROUND

  • Radua J, Grunze H, Amann BL. Meta-Analysis of the Risk of Subsequent Mood Episodes in Bipolar Disorder. Psychother Psychosom. 2017;86(2):90-98. doi: 10.1159/000449417. Epub 2017 Feb 10.

    PMID: 28183076BACKGROUND

  • Schouws SN, Stek ML, Comijs HC, Dols A, Beekman AT. Cognitive decline in elderly bipolar disorder patients: a follow-up study. Bipolar Disord. 2012 Nov;14(7):749-55. doi: 10.1111/bdi.12000. Epub 2012 Sep 21.

    PMID: 22998105BACKGROUND

  • Spijker, J., Bockting, C.L.H., Meeuwissen, J.A.C., et al. (2013) Dutch Multidisciplinary guideline for Depression: Trimbos Institute.

    BACKGROUND

  • Strohle A, Schmidt DK, Schultz F, Fricke N, Staden T, Hellweg R, Priller J, Rapp MA, Rieckmann N. Drug and Exercise Treatment of Alzheimer Disease and Mild Cognitive Impairment: A Systematic Review and Meta-Analysis of Effects on Cognition in Randomized Controlled Trials. Am J Geriatr Psychiatry. 2015 Dec;23(12):1234-1249. doi: 10.1016/j.jagp.2015.07.007. Epub 2015 Jul 21.

    PMID: 26601726BACKGROUND

  • van der Stel JC. [Functional recovery and self-regulation: assignments for both clients and psychiatrists]. Tijdschr Psychiatr. 2015;57(11):815-22. Dutch.

    PMID: 26552928BACKGROUND

  • van Liempt S, Dols A, Schouws S, Stek ML, Meesters PD. Comparison of social functioning in community-living older individuals with schizophrenia and bipolar disorder: a catchment area-based study. Int J Geriatr Psychiatry. 2017 May;32(5):532-538. doi: 10.1002/gps.4490. Epub 2016 Apr 27.

    PMID: 27121916BACKGROUND

  • Willis SL, Tennstedt SL, Marsiske M, Ball K, Elias J, Koepke KM, Morris JN, Rebok GW, Unverzagt FW, Stoddard AM, Wright E; ACTIVE Study Group. Long-term effects of cognitive training on everyday functional outcomes in older adults. JAMA. 2006 Dec 20;296(23):2805-14. doi: 10.1001/jama.296.23.2805.

    PMID: 17179457BACKGROUND

  • Yliruka, L. (2012) 'The Mirror Method: a structure supporting expertise in social welfare services.', Social Work & Social Sciences Review., 15(2), pp. 9-37.

    BACKGROUND

  • Oudega ML, Wagenmakers MJ, Palsma T, Hoogendoorn AW, Vriend C, van den Heuvel OA, Schouws S, Dols A. BrainFit: improving executive and subjective cognitive functioning in late-life mood disorders - a double-blind randomized active-controlled study evaluating the effect of online cognitive training. Front Psychiatry. 2025 Jan 2;15:1509821. doi: 10.3389/fpsyt.2024.1509821. eCollection 2024.

    PMID: 39822386DERIVED

MeSH Terms

Conditions

DepressionCognition Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorNeurocognitive DisordersMental Disorders

Study Officials

  • Annemiek Dols, MD, PhD

    Amsterdam UMC, location VUmc

    PRINCIPAL INVESTIGATOR

  • Mardien Oudega, MD, PhD

    Amsterdam UMC, location VUmc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Psychiatrist, Prinicipal Investigator

Study Record Dates

First Submitted

February 12, 2019

First Posted

July 5, 2019

Study Start

September 17, 2019

Primary Completion

November 11, 2021

Study Completion

November 11, 2021

Last Updated

December 1, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)