Our primary goal is to develop an easy access cognitive training for older patients with mood disorders suffering from (subjective) cognitive complaints. We want to study the effect on both objective and subjective functioning. Secondary, we aim to…
ID
Source
Brief title
Condition
- Other condition
- Mood disorders and disturbances NEC
Synonym
Health condition
cognitieve klachten
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is the effect on cognitive executive functioning (Stroop
Task).
Secondary outcome
Secondary outcome measures includes objective cognitive functioning, and also
the effect on mood symptoms, social functioning, quality of life and sense of
Mastery. Also the feasability of the training will be studies.
Background summary
Relevance
An effective therapeutic intervention for cognitive impairment is an important
unmet medical need in patients with late onset mood disorders (LLMD).
Cognitive impairment is a core feature of the illness and responsible for poor
outcome. By treating cognitive impairment we expect to improve cognition and
depressive symptoms in LLMD. Additionally, as cognition is related to social
functioning, an effect of cognitive training on improvement of social
functioning is to be expected. In current treatments, cognitive complaints are
highly underestimated, with a less positive prognoses for these patients.
Cognitive training has showed its benefits in other diseases. Our primary goal
is to investigate the effect on (subjective) cognitive symptoms. A secondary
goal is to explore the effect on objective cognitive functioning, moodsymptoms,
social functioning and the feasability of an online cognitive training for
depressed patients.
Study objective
Our primary goal is to develop an easy access cognitive training for older
patients with mood disorders suffering from (subjective) cognitive complaints.
We want to study the effect on both objective and subjective functioning.
Secondary, we aim to study the effect on mood symptoms, social functioning and
the feeling of Mastery and quality of life. Furthermore we aim to study whether
the effects will last during 3 months after quitting the training. Also we want
to enlight the feasability of the online cognitive training for our study
population.
Study design
In this current dubbelblind, randomized controlled study patients will be
randomly assigned to the online cognitive training (BrainGymmer > executive
functioning, attention) versus the active control cognitive training (no
specific trainingseffect expected). We will stratify for polarity (unipolar and
bipolar depression). This active control condition is different from Care as
usual as control-condition, by profiding this active control training we hope
to rule out a-specific effects.
Patients will train 3 x/week 45 minutes for 8 weeks. We will do pre-post- and
follow-up measures three months after the last training.
Intervention
Intervention
The training games are specifically designed to enhance attention, information
processing speed, working memory and executive functioning, cognitive domains
that are commonly affected in LLMD, by dynamically adjusting to the
individual*s performance. As a comparator we use an active control condition
where patients play games that do not make great demands on executive processes
(solitaire) or rely on general knowledge (hangman, trivia questions). The
training can be performed at the patient*s convenience at their preferred place
and time on a computer or tablet. Both conditions will last approximately 45
minutes, three times a week during eight weeks.
Study burden and risks
Risks
During the study, the participant will be asked to come over to GGZ inGeest for
four times. First for intake and neuropsychological assessment. If no inclusion
> questionnaires (1.5 - 2 hours). second for explanation of the training, third
and fourth for post-training measurements. On voluntary basis participants are
asked to joing mirror sessions or feedback sessions to evaluate the training in
a group ow fewllow participants.
If possible the visits will be combined with appointments that where already
planned for regular care. If traveling is too much of a burden for the
participants, the screening, neuropsychological assessment and questionnaires
can take place at home. During the intervention, participants need to train for
45 minutes, three times a week during 8 weeks. This can either be the online
cognitive trainingprogram or a 'control' training. We think the risk
negligible. Based on a previous study we do even expect beneifts for the
partcipants.
Amstelveenseweg 589
Amsterdam 1070 BB
NL
Amstelveenseweg 589
Amsterdam 1070 BB
NL
Listed location countries
Age
Inclusion criteria
- Subjective cognitive complaints measured with the Subjective Cognitive
Failure Questionnaire, with a cut-off of * 44.
- 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.
-
Exclusion criteria
- Possible Dementia syndrome, measured by the Montreal Cognitive Assessment
score < 22, or when described in the medical file.
- Drugs- of alcohol abuse, measured by CAGE-AID = 1.
- Inability to do a neuropsychological assesment or to do the computerized
intervention (fatigue, eye complaints or language barrier).
- Current psychotic symptoms as described in their medical file.
- Serious suicidal thoughts
- Serious personality disorder as main diagnosis.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL69568.029.19 |