A Study on Better Cognitive Functioning Through Braintraining on the Internet (BrainFit)
Primary Purpose
Depression, Late Life Mood Disorder, Impaired Cognition
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Online cognitive training 1
Online cognitive training 2
Sponsored by
About this trial
This is an interventional treatment trial for Depression
Eligibility Criteria
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
Sites / Locations
- GGZ inGeest
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Online cognitive training 1
Online cognitive training 2
Arm Description
Eight-week, three times a week during 45 minutes cognitive training
Eight-week, three times a week during 45 minutes cognitive activities
Outcomes
Primary Outcome Measures
Feasability of the intervention measured via therapy compliance and drop-out
therapy compliance, drop-out
Appreciation of the intervention
Questionnaire on difficulty, feasability, joy, effort, challenge of the therapy, clearness of the intervention explanation, evaluation groups (mirror groups)
Secondary Outcome Measures
Subjective cognitive functioning measured via the CFQ
Cognitive failures Questionnaire
Genaral objective cognitive functioning via the MOCA
Montreal Cognitive Assessment
Mood symptoms via MADRS
Montgomery Asberg Depression Rating Scale
Quality of life via the MANSA
Manchester Short Assessment of quality of Life
Sense of Mastery via Mastery questionnaire
Mastery questionnaire
Physical activity via NZPAQ-SF
New Zealand Physical Activity Questionnaire - Short Form
Believe and expectancy of the intervention via credibility/expectancy questionnaire
credibility/expectancy questionnaire
Social andf occupational functioning via SOFAS
social and occupation functioning assessment scale
Full Information
NCT ID
NCT04006756
First Posted
February 12, 2019
Last Updated
November 30, 2021
Sponsor
Amsterdam UMC, location VUmc
1. Study Identification
Unique Protocol Identification Number
NCT04006756
Brief Title
A Study on Better Cognitive Functioning Through Braintraining on the Internet
Acronym
BrainFit
Official Title
BrainFit: The Effect of Online Cognitive Training in Patients With Late Life Mood Disorders.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
September 17, 2019 (Actual)
Primary Completion Date
November 11, 2021 (Actual)
Study Completion Date
November 11, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Amsterdam UMC, location VUmc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Late Life Mood Disorder, Impaired Cognition, Alteration in Mood, Alteration in Cognition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Online cognitive training 1
Arm Type
Experimental
Arm Description
Eight-week, three times a week during 45 minutes cognitive training
Arm Title
Online cognitive training 2
Arm Type
Active Comparator
Arm Description
Eight-week, three times a week during 45 minutes cognitive activities
Intervention Type
Behavioral
Intervention Name(s)
Online cognitive training 1
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Online cognitive training 2
Intervention Description
Eight-week online active comparator program, three times a week for 45 minutes. The training contains several games.
Primary Outcome Measure Information:
Title
Feasability of the intervention measured via therapy compliance and drop-out
Description
therapy compliance, drop-out
Time Frame
Eight weeks (T1)
Title
Appreciation of the intervention
Description
Questionnaire on difficulty, feasability, joy, effort, challenge of the therapy, clearness of the intervention explanation, evaluation groups (mirror groups)
Time Frame
Eight weeks (T1)
Secondary Outcome Measure Information:
Title
Subjective cognitive functioning measured via the CFQ
Description
Cognitive failures Questionnaire
Time Frame
Eight weeks (T1) and 3 months (T2)
Title
Genaral objective cognitive functioning via the MOCA
Description
Montreal Cognitive Assessment
Time Frame
Eight weeks (T1) and 3 months (T2)
Title
Mood symptoms via MADRS
Description
Montgomery Asberg Depression Rating Scale
Time Frame
Eight weeks (T1) and 3 months (T2)
Title
Quality of life via the MANSA
Description
Manchester Short Assessment of quality of Life
Time Frame
Eight weeks (T1) and 3 months (T2)
Title
Sense of Mastery via Mastery questionnaire
Description
Mastery questionnaire
Time Frame
Eight weeks (T1) and 3 months (T2)
Title
Physical activity via NZPAQ-SF
Description
New Zealand Physical Activity Questionnaire - Short Form
Time Frame
Eight weeks (T1) and 3 months (T2)
Title
Believe and expectancy of the intervention via credibility/expectancy questionnaire
Description
credibility/expectancy questionnaire
Time Frame
Week 0 (T0)
Title
Social andf occupational functioning via SOFAS
Description
social and occupation functioning assessment scale
Time Frame
Eight weeks (T1) and 3 months (T2)
Other Pre-specified Outcome Measures:
Title
Apathy via apathy scale
Description
apathy scale
Time Frame
Eight weeks (T1) and 3 months (T2)
Title
Global cognitive dysfunction via the Pentagon Drawing Test
Description
Pentagon Drawing Test
Time Frame
Eight weeks (T1) and 3 months (T2)
Title
Information processing speed and inhibition via the STROOP-test
Description
STROOP-test
Time Frame
Eight weeks (T1) and 3 months (T2)
Title
Verbal functioning via verbal letter fluency test
Description
verbal letter fluency test
Time Frame
Eight weeks (T1) and 3 months (T2)
Title
Cognitive functioning via SDMT
Description
symbol digit modalitities test
Time Frame
Eight weeks (T1) and 3 months (T2)
Title
Cognitive functioning via VAT
Description
Verbal Assessment Test
Time Frame
Eight weeks (T1) and 3 months (T2)
Title
Cognitive functioning via TMT
Description
trail making test
Time Frame
Eight weeks (T1) and 3 months (T2)
Title
Cognitive functioning via 15-Woordentest
Description
15-Woordentest
Time Frame
Eight weeks (T1) and 3 months (T2)
Title
Cognitive functioning via BNT short version - 30
Description
Boston naming test, short version
Time Frame
Eight weeks (T1) and 3 months (T2)
Title
Cogntive functioning via category fluency test
Description
category fluency test
Time Frame
Eight weeks (T1) and 3 months (T2)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annemiek Dols, MD, PhD
Organizational Affiliation
Amsterdam UMC, location VUmc
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mardien Oudega, MD, PhD
Organizational Affiliation
Amsterdam UMC, location VUmc
Official's Role
Principal Investigator
Facility Information:
Facility Name
GGZ inGeest
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1081 JC
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
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A Study on Better Cognitive Functioning Through Braintraining on the Internet
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