A Study on Better Cognitive Functioning Through Braintraining on the Internet (BrainFit)

November 30, 2021 updated by: Annemiek Dols, MD, PhD, Amsterdam UMC, location VUmc

BrainFit: The Effect of Online Cognitive Training in Patients With Late Life Mood Disorders.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND OF THE STUDY Late life mood disorders (LLMD) include patients with unipolar depression and bipolar disorder, aged 50 years and over. Despite the fact that evidence-based pharmacological and psychotherapeutic interventions have proven effective, many patients with LLMD experience relapse or partial remission.

One of the reasons for unfavorable treatment outcome is that LLMD are often accompanied with cognitive impairment (attention, processing speed, memory and executive function) during an episode and after remission.This cognitive impairment in LLMD is associated with worse social functioning , distress to patients and caregivers, decreased quality of life and an unfavorable prognosis, including nursing home admission.

Several dimensions of recovery can be distinguished and are known to influence each other. For example, addressing functional recovery by improving cognitive functioning may enhance clinical recovery (less mood symptoms) and social functioning . Therefore, addressing cognitive impairment in LLMD may improve overall functioning and recovery rates.

Strategies to improve cognitive functioning with cognitive training and/or remediation are lacking for LLMD. Cognitive training has been effective in healthy older adults and in patients with mild cognitive impairment (MCI) and dementia.

A meta-analysis of adult patients with major depressive disorder showed that computerized cognitive training is associated with improvement in depressive symptoms and everyday functioning, though effects on cognition are inconsistent, with moderate to large effects for attention, working memory and global functioning and no effects for executive functioning and verbal memory. However, a small study including both unipolar and bipolar adult patients (n=15) and a control group (n=16) observed improvements in shifting, divided attention, global executive control after an online cognitive training. In addition, improved subjective cognitive functioning, reduced depression levels and less difficulty in everyday coping were observed.

In sum, cognitive impairment is a core feature of LLMD, contributes markedly to disability but is overlooked in current evidence-based treatment programs and therefore a less positive prognosis for these patients. An effective evidence-based treatment approach addressing cognitive impairment in LLMD is warranted.

AIM To age successfully, effective coping styles and social and community involvement are important. In the general population social activities and memory training are promoted for older persons as strategies to optimize resilience and to prolong independent living. Nevertheless, for the increasing number of patients with LLMD, effective interventions to improve cognition and social functioning are not available.

With the proposed pilot study we aim to seek a feasible and effective treatment to improve cognition, social functioning and quality of life of our patients. We aim to evaluate the feasibility of the online cognitive training (BrainGymmer) in a double-blind randomized control pilot-study.

If proven to be feasible, our intention is to expand the current pilot study to a RCT to test the efficacy of the proposed online cognitive training in patients with LLMD. After efficacy has been proven, the cognitive training program can also be used in other mental health departments, and even be made available through initiatives such as GGD appstore and onlinehulpstempel.nl.

OUTCOME At baseline, after the intervention period and 3 months after training, measurements will be taken. Our primary outcome measures will feasibility and appreciation of the intervention. Evaluation of therapy compliance, drop-out, and evaluation of the patients will be done with use of questionnaires on difficulty, feasibility, joy, effort, challenge of the therapy and clearness of the intervention explanation. Furthermore, evaluation groups (also mirror groups) will be held. In these discussion groups we will evaluate the study together with patients.

Secondary outcome measures include subjective and objective cognitive functioning, mood symptoms social functioning, quality of life and sense of Mastery.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1081 JC
        • GGz inGeest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 50 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Online cognitive training 1
Eight-week, three times a week during 45 minutes cognitive training
Behavioral: Online cognitive training 1
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.
ACTIVE_COMPARATOR: Online cognitive training 2
Eight-week, three times a week during 45 minutes cognitive activities
Behavioral: Online cognitive training 2
Eight-week online active comparator program, three times a week for 45 minutes. The training contains several games.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasability of the intervention measured via therapy compliance and drop-out
Time Frame: Eight weeks (T1)
therapy compliance, drop-out
Eight weeks (T1)
Appreciation of the intervention
Time Frame: Eight weeks (T1)
Questionnaire on difficulty, feasability, joy, effort, challenge of the therapy, clearness of the intervention explanation, evaluation groups (mirror groups)
Eight weeks (T1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective cognitive functioning measured via the CFQ
Time Frame: Eight weeks (T1) and 3 months (T2)
Cognitive failures Questionnaire
Eight weeks (T1) and 3 months (T2)
Genaral objective cognitive functioning via the MOCA
Time Frame: Eight weeks (T1) and 3 months (T2)
Montreal Cognitive Assessment
Eight weeks (T1) and 3 months (T2)
Mood symptoms via MADRS
Time Frame: Eight weeks (T1) and 3 months (T2)
Montgomery Asberg Depression Rating Scale
Eight weeks (T1) and 3 months (T2)
Quality of life via the MANSA
Time Frame: Eight weeks (T1) and 3 months (T2)
Manchester Short Assessment of quality of Life
Eight weeks (T1) and 3 months (T2)
Sense of Mastery via Mastery questionnaire
Time Frame: Eight weeks (T1) and 3 months (T2)
Mastery questionnaire
Eight weeks (T1) and 3 months (T2)
Physical activity via NZPAQ-SF
Time Frame: Eight weeks (T1) and 3 months (T2)
New Zealand Physical Activity Questionnaire - Short Form
Eight weeks (T1) and 3 months (T2)
Believe and expectancy of the intervention via credibility/expectancy questionnaire
Time Frame: Week 0 (T0)
credibility/expectancy questionnaire
Week 0 (T0)
Social andf occupational functioning via SOFAS
Time Frame: Eight weeks (T1) and 3 months (T2)
social and occupation functioning assessment scale
Eight weeks (T1) and 3 months (T2)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apathy via apathy scale
Time Frame: Eight weeks (T1) and 3 months (T2)
apathy scale
Eight weeks (T1) and 3 months (T2)
Global cognitive dysfunction via the Pentagon Drawing Test
Time Frame: Eight weeks (T1) and 3 months (T2)
Pentagon Drawing Test
Eight weeks (T1) and 3 months (T2)
Information processing speed and inhibition via the STROOP-test
Time Frame: Eight weeks (T1) and 3 months (T2)
STROOP-test
Eight weeks (T1) and 3 months (T2)
Verbal functioning via verbal letter fluency test
Time Frame: Eight weeks (T1) and 3 months (T2)
verbal letter fluency test
Eight weeks (T1) and 3 months (T2)
Cognitive functioning via SDMT
Time Frame: Eight weeks (T1) and 3 months (T2)
symbol digit modalitities test
Eight weeks (T1) and 3 months (T2)
Cognitive functioning via VAT
Time Frame: Eight weeks (T1) and 3 months (T2)
Verbal Assessment Test
Eight weeks (T1) and 3 months (T2)
Cognitive functioning via TMT
Time Frame: Eight weeks (T1) and 3 months (T2)
trail making test
Eight weeks (T1) and 3 months (T2)
Cognitive functioning via 15-Woordentest
Time Frame: Eight weeks (T1) and 3 months (T2)
15-Woordentest
Eight weeks (T1) and 3 months (T2)
Cognitive functioning via BNT short version - 30
Time Frame: Eight weeks (T1) and 3 months (T2)
Boston naming test, short version
Eight weeks (T1) and 3 months (T2)
Cogntive functioning via category fluency test
Time Frame: Eight weeks (T1) and 3 months (T2)
category fluency test
Eight weeks (T1) and 3 months (T2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amsterdam UMC, location VUmc

Investigators

  • Principal Investigator: Annemiek Dols, MD, PhD, Amsterdam UMC, location VUmc
  • Principal Investigator: Mardien Oudega, MD, PhD, Amsterdam UMC, location VUmc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 17, 2019

Primary Completion (ACTUAL)

November 11, 2021

Study Completion (ACTUAL)

November 11, 2021

Study Registration Dates

First Submitted

February 12, 2019

First Submitted That Met QC Criteria

June 30, 2019

First Posted (ACTUAL)

July 5, 2019

Study Record Updates

Last Update Posted (ACTUAL)

December 1, 2021

Last Update Submitted That Met QC Criteria

November 30, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL58750.029.16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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