DepressionBrainFitNCT04006756
A Study on Better Cognitive Functioning Through Braintraining on the Internet
A study testing Online cognitive training 1 and Online cognitive training 2 in people with Depression and Late Life Mood Disorder, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Depression, Late Life Mood Disorder, Impaired Cognition
- What is being tested?
- Online cognitive training 1 and Online cognitive training 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Sep 2019to 11 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Depression, Late Life Mood Disorder, Impaired Cognition, Alteration in Mood, Alteration in Cognition
- Being tested
- Online cognitive training 1, Online cognitive training 2
- Medical subject headings
- Depression, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online cognitive training 1Behavioural
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 2Behavioural
Eight-week online active comparator program, three times a week for 45 minutes. The training contains several games.
| Study group | Role | What they receive |
|---|---|---|
| Online cognitive training 1 | Experimental | Eight-week, three times a week during 45 minutes cognitive training Receives: Behavioral: Online cognitive training 1 |
| Online cognitive training 2 | Active comparator | Eight-week, three times a week during 45 minutes cognitive activities Receives: Behavioral: Online cognitive training 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasability of the intervention measured via therapy compliance and drop-out
therapy compliance, drop-out
Measured: Eight weeks (T1)
Appreciation of the intervention
Questionnaire on difficulty, feasability, joy, effort, challenge of the therapy, clearness of the intervention explanation, evaluation groups (mirror groups)
Measured: Eight weeks (T1)
Secondary outcomes (8)
Subjective cognitive functioning measured via the CFQ
Cognitive failures Questionnaire
Measured: Eight weeks (T1) and 3 months (T2)
Genaral objective cognitive functioning via the MOCA
Montreal Cognitive Assessment
Measured: Eight weeks (T1) and 3 months (T2)
Mood symptoms via MADRS
Montgomery Asberg Depression Rating Scale
Measured: Eight weeks (T1) and 3 months (T2)
Quality of life via the MANSA
Manchester Short Assessment of quality of Life
Measured: Eight weeks (T1) and 3 months (T2)
Sense of Mastery via Mastery questionnaire
Mastery questionnaire
Measured: Eight weeks (T1) and 3 months (T2)
Physical activity via NZPAQ-SF
New Zealand Physical Activity Questionnaire - Short Form
Measured: Eight weeks (T1) and 3 months (T2)
Believe and expectancy of the intervention via credibility/expectancy questionnaire
credibility/expectancy questionnaire
Measured: Week 0 (T0)
Social andf occupational functioning via SOFAS
social and occupation functioning assessment scale
Measured: Eight weeks (T1) and 3 months (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start17 Sep 2019
- Primary completion11 Nov 2021
- Study completion11 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annemiek Dols, MD, PhD, Amsterdam UMC, location VUmc
- Investigators
- Annemiek Dols, MD, PhD, Principal investigator, Amsterdam UMC, location VUmcMardien Oudega, MD, PhD, Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04006756
- Sponsor's protocol ID
- NL58750.029.16
- Acronym
- BrainFit
- Status last verified
- Nov 2021
- First submitted
- 12 Feb 2019
- Last updated
- 1 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20192798Farrand 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.
PubMed 26817638Harris Y, Cooper JK. Depressive symptoms in older people predict nursing home admission. J Am Geriatr Soc. 2006 Apr;54(4):593-7. doi: 10.1111/j.1532-5415.2006.00687.x.
PubMed 16686868Korten 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.
PubMed 24565278Kuiper 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. doi: 10.1093/ije/dyw089. Epub 2016 Jun 6.
PubMed 27272181Motter 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.
PubMed 26437233Preiss M, Shatil E, Cermakova R, Cimermanova 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.
PubMed 23717272Radua 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.
PubMed 28183076Schouws 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.
PubMed 22998105Spijker, J., Bockting, C.L.H., Meeuwissen, J.A.C., et al. (2013) Dutch Multidisciplinary guideline for Depression: Trimbos Institute.
Strohle 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.
PubMed 26601726van der Stel JC. [Functional recovery and self-regulation: assignments for both clients and psychiatrists]. Tijdschr Psychiatr. 2015;57(11):815-22. Dutch.
PubMed 26552928van 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.
PubMed 27121916Willis 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. doi: 10.1001/jama.296.23.2805.
PubMed 17179457Yliruka, L. (2012) 'The Mirror Method: a structure supporting expertise in social welfare services.', Social Work & Social Sciences Review., 15(2), pp. 9-37.
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BrainFit: The Effect of Online Cognitive Training in Patients With Late Life Mood Disorders.
- ClinicalTrials.gov ID
- NCT04006756
- Acronym / sponsor ID
- BrainFit / NL58750.029.16
- Conditions
- Depression, Late Life Mood Disorder, Impaired Cognition, Alteration in Mood, Alteration in Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 17 Sep 2019 (actual)
- Primary completion
- 11 Nov 2021 (actual)
- Study completion
- 11 Nov 2021 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online cognitive training 1 | Experimental | Behavioral: Online cognitive training 1Eight-week, three times a week during 45 minutes cognitive training |
| Online cognitive training 2 | Active comparator | Behavioral: Online cognitive training 2Eight-week, three times a week during 45 minutes cognitive activities |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- current psychotic symptoms
- severe suicidal ideations
- severe personality disorder (as a main diagnosis)
- severe alcohol or substance abuse
- insufficient mastery of the Dutch language.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online cognitive training 1Eight-week online cognitive training program, three times a week for 45 minutes. The training contains several games that are designed to train cognitive functions. | Behavioural | Online cognitive training 1 |
| Online cognitive training 2Eight-week online active comparator program, three times a week for 45 minutes. The training contains several games. | Behavioural | Online cognitive training 2 |
Primary outcome
Feasability of the intervention measured via therapy compliance and drop-out
Time frame: Eight weeks (T1)
therapy compliance, drop-out
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)
8 secondary outcomes
Subjective cognitive functioning measured via the CFQ
Time frame: Eight weeks (T1) and 3 months (T2)
Genaral objective cognitive functioning via the MOCA
Time frame: Eight weeks (T1) and 3 months (T2)
Mood symptoms via MADRS
Time frame: Eight weeks (T1) and 3 months (T2)
Quality of life via the MANSA
Time frame: Eight weeks (T1) and 3 months (T2)
Sense of Mastery via Mastery questionnaire
Time frame: Eight weeks (T1) and 3 months (T2)
Physical activity via NZPAQ-SF
Time frame: Eight weeks (T1) and 3 months (T2)
Believe and expectancy of the intervention via credibility/expectancy questionnaire
Time frame: Week 0 (T0)
Social andf occupational functioning via SOFAS
Time frame: Eight weeks (T1) and 3 months (T2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
- Background: PubMed 20192798Depp 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.
- Background: PubMed 26817638Farrand 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.
- Background: PubMed 16686868Harris Y, Cooper JK. Depressive symptoms in older people predict nursing home admission. J Am Geriatr Soc. 2006 Apr;54(4):593-7. doi: 10.1111/j.1532-5415.2006.00687.x.
- Background: PubMed 24565278Korten 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.
- Background: PubMed 27272181Kuiper 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. doi: 10.1093/ije/dyw089. Epub 2016 Jun 6.
- Background: PubMed 26437233Motter 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.
- Background: PubMed 23717272Preiss M, Shatil E, Cermakova R, Cimermanova 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.
- Background: PubMed 28183076Radua 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.
- Background: PubMed 22998105Schouws 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.
- BackgroundSpijker, J., Bockting, C.L.H., Meeuwissen, J.A.C., et al. (2013) Dutch Multidisciplinary guideline for Depression: Trimbos Institute.
- Background: PubMed 26601726Strohle 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.
- Background: PubMed 26552928van der Stel JC. [Functional recovery and self-regulation: assignments for both clients and psychiatrists]. Tijdschr Psychiatr. 2015;57(11):815-22. Dutch.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annemiek Dols, MD, PhD principal investigator
Amsterdam UMC, location VUmc
Mardien Oudega, MD, PhD principal investigator
Amsterdam UMC, location VUmc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online cognitive training 1 and Online cognitive training 2 in people with Depression and Late Life Mood Disorder, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasability of the intervention measured via therapy compliance and drop-out (time frame: Eight weeks (T1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04006756, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2021.