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A Study on Better Cognitive Functioning Through Braintraining on the Internet

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04006756
Acronym
BrainFit
Enrollment
38
Registered
2019-07-05
Start date
2019-09-17
Completion date
2021-11-11
Last updated
2021-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alteration in Cognition, Alteration in Mood, Depression, Impaired Cognition, Late Life Mood Disorder

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.

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.

Interventions

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.

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

Sponsors

Amsterdam UMC, location VUmc
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Feasability of the intervention measured via therapy compliance and drop-outEight weeks (T1)therapy compliance, drop-out
Appreciation of the interventionEight weeks (T1)Questionnaire on difficulty, feasability, joy, effort, challenge of the therapy, clearness of the intervention explanation, evaluation groups (mirror groups)

Secondary

MeasureTime frameDescription
Subjective cognitive functioning measured via the CFQEight weeks (T1) and 3 months (T2)Cognitive failures Questionnaire
Genaral objective cognitive functioning via the MOCAEight weeks (T1) and 3 months (T2)Montreal Cognitive Assessment
Mood symptoms via MADRSEight weeks (T1) and 3 months (T2)Montgomery Asberg Depression Rating Scale
Quality of life via the MANSAEight weeks (T1) and 3 months (T2)Manchester Short Assessment of quality of Life
Sense of Mastery via Mastery questionnaireEight weeks (T1) and 3 months (T2)Mastery questionnaire
Physical activity via NZPAQ-SFEight weeks (T1) and 3 months (T2)New Zealand Physical Activity Questionnaire - Short Form
Believe and expectancy of the intervention via credibility/expectancy questionnaireWeek 0 (T0)credibility/expectancy questionnaire
Social andf occupational functioning via SOFASEight weeks (T1) and 3 months (T2)social and occupation functioning assessment scale

Other

MeasureTime frameDescription
Apathy via apathy scaleEight weeks (T1) and 3 months (T2)apathy scale
Global cognitive dysfunction via the Pentagon Drawing TestEight weeks (T1) and 3 months (T2)Pentagon Drawing Test
Information processing speed and inhibition via the STROOP-testEight weeks (T1) and 3 months (T2)STROOP-test
Verbal functioning via verbal letter fluency testEight weeks (T1) and 3 months (T2)verbal letter fluency test
Cognitive functioning via SDMTEight weeks (T1) and 3 months (T2)symbol digit modalitities test
Cognitive functioning via VATEight weeks (T1) and 3 months (T2)Verbal Assessment Test
Cognitive functioning via TMTEight weeks (T1) and 3 months (T2)trail making test
Cognitive functioning via 15-WoordentestEight weeks (T1) and 3 months (T2)15-Woordentest
Cognitive functioning via BNT short version - 30Eight weeks (T1) and 3 months (T2)Boston naming test, short version
Cogntive functioning via category fluency testEight weeks (T1) and 3 months (T2)category fluency test

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026