Clinical trial NCT04006756: A Study on Better Cognitive Functioning Through Braintraining on the Internet
Official title: BrainFit: The Effect of Online Cognitive Training in Patients With Late Life Mood Disorders.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Late Life Mood Disorder
Impaired Cognition
Alteration in Mood
Alteration in Cognition
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 38
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Feasability of the intervention measured via therapy compliance and drop-out
timeFrame: Eight weeks (T1)
measure: Appreciation of the intervention
timeFrame: Eight weeks (T1)
Secondary outcomes:
measure: Subjective cognitive functioning measured via the CFQ
timeFrame: Eight weeks (T1) and 3 months (T2)
measure: Genaral objective cognitive functioning via the MOCA
timeFrame: Eight weeks (T1) and 3 months (T2)
measure: Mood symptoms via MADRS
timeFrame: Eight weeks (T1) and 3 months (T2)
measure: Quality of life via the MANSA
timeFrame: Eight weeks (T1) and 3 months (T2)
measure: Sense of Mastery via Mastery questionnaire
timeFrame: Eight weeks (T1) and 3 months (T2)
measure: Physical activity via NZPAQ-SF
timeFrame: Eight weeks (T1) and 3 months (T2)
measure: Believe and expectancy of the intervention via credibility/expectancy questionnaire
timeFrame: Week 0 (T0)
measure: Social andf occupational functioning via SOFAS
timeFrame: Eight weeks (T1) and 3 months (T2)
Other outcomes:
measure: Apathy via apathy scale
timeFrame: Eight weeks (T1) and 3 months (T2)
measure: Global cognitive dysfunction via the Pentagon Drawing Test
timeFrame: Eight weeks (T1) and 3 months (T2)
measure: Information processing speed and inhibition via the STROOP-test
timeFrame: Eight weeks (T1) and 3 months (T2)
measure: Verbal functioning via verbal letter fluency test
timeFrame: Eight weeks (T1) and 3 months (T2)
measure: Cognitive functioning via SDMT
timeFrame: Eight weeks (T1) and 3 months (T2)
measure: Cognitive functioning via VAT
timeFrame: Eight weeks (T1) and 3 months (T2)
measure: Cognitive functioning via TMT
timeFrame: Eight weeks (T1) and 3 months (T2)
measure: Cognitive functioning via 15-Woordentest
timeFrame: Eight weeks (T1) and 3 months (T2)
measure: Cognitive functioning via BNT short version - 30
timeFrame: Eight weeks (T1) and 3 months (T2)
measure: Cogntive functioning via category fluency test
timeFrame: Eight weeks (T1) and 3 months (T2)
Locations:
city: Amsterdam
country: Netherlands
facility: GGZ inGeest
state: Noord-Holland
Study officials:
affiliation: Amsterdam UMC, location VUmc
name: Annemiek Dols, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Amsterdam UMC, location VUmc
name: Mardien Oudega, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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