A Study on Better Cognitive Functioning Through Braintraining on the Internet

Depression Clinical Trial

— BrainFit  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04006756
• Other study ID #: NL58750.029.16
• Status: Completed
• Phase: N/A
• Start date: September 17, 2019
• Est. completion date: November 11, 2021

Study information

• Verified date: November 2021
• Source: VU University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: November 11, 2021
• Est. primary completion date: November 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alteration in Cognition
• Alteration in Mood
• Cognitive Dysfunction
• Depression
• Impaired Cognition
• Late Life Mood Disorder
• Mood Disorders

Intervention

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.
• Online cognitive training 2
Eight-week online active comparator program, three times a week for 45 minutes. The training contains several games.

Locations

Country	Name	City	State
Netherlands	GGZ inGeest	Amsterdam	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
VU University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (15)

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. Review. — View Citation

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. — View Citation

Harris Y, Cooper JK. Depressive symptoms in older people predict nursing home admission. J Am Geriatr Soc. 2006 Apr;54(4):593-7. — View Citation

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. — View Citation

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. Epub 2016 Jun 6. Review. — View Citation

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. Review. — View Citation

Preiss M, Shatil E, Cermáková R, Cimermanová 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. — View Citation

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. — View Citation

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. — View Citation

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

Ströhle 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. Review. — View Citation

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

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. — View Citation

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. — View Citation

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

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Apathy via apathy scale	apathy scale	Eight weeks (T1) and 3 months (T2)
Other	Global cognitive dysfunction via the Pentagon Drawing Test	Pentagon Drawing Test	Eight weeks (T1) and 3 months (T2)
Other	Information processing speed and inhibition via the STROOP-test	STROOP-test	Eight weeks (T1) and 3 months (T2)
Other	Verbal functioning via verbal letter fluency test	verbal letter fluency test	Eight weeks (T1) and 3 months (T2)
Other	Cognitive functioning via SDMT	symbol digit modalitities test	Eight weeks (T1) and 3 months (T2)
Other	Cognitive functioning via VAT	Verbal Assessment Test	Eight weeks (T1) and 3 months (T2)
Other	Cognitive functioning via TMT	trail making test	Eight weeks (T1) and 3 months (T2)
Other	Cognitive functioning via 15-Woordentest	15-Woordentest	Eight weeks (T1) and 3 months (T2)
Other	Cognitive functioning via BNT short version - 30	Boston naming test, short version	Eight weeks (T1) and 3 months (T2)
Other	Cogntive functioning via category fluency test	category fluency test	Eight weeks (T1) and 3 months (T2)
Primary	Feasability of the intervention measured via therapy compliance and drop-out	therapy compliance, drop-out	Eight weeks (T1)
Primary	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	Subjective cognitive functioning measured via the CFQ	Cognitive failures Questionnaire	Eight weeks (T1) and 3 months (T2)
Secondary	Genaral objective cognitive functioning via the MOCA	Montreal Cognitive Assessment	Eight weeks (T1) and 3 months (T2)
Secondary	Mood symptoms via MADRS	Montgomery Asberg Depression Rating Scale	Eight weeks (T1) and 3 months (T2)
Secondary	Quality of life via the MANSA	Manchester Short Assessment of quality of Life	Eight weeks (T1) and 3 months (T2)
Secondary	Sense of Mastery via Mastery questionnaire	Mastery questionnaire	Eight weeks (T1) and 3 months (T2)
Secondary	Physical activity via NZPAQ-SF	New Zealand Physical Activity Questionnaire - Short Form	Eight weeks (T1) and 3 months (T2)
Secondary	Believe and expectancy of the intervention via credibility/expectancy questionnaire	credibility/expectancy questionnaire	Week 0 (T0)
Secondary	Social andf occupational functioning via SOFAS	social and occupation functioning assessment scale	Eight weeks (T1) and 3 months (T2)