DepressionNCT02184481
Working Memory Training for Dysphoric Students
A study testing Working memory training in people with Depression, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
Depression is associated with impairments in executive functions, including working memory (WM) which is needed to maintain and manipulate goal-relevant information. Due to these WM impairments depressed individuals have difficulties inhibiting and shifting from irrelevant (negative) information and updating goal… Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Working memory training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2013to Jun 2014
- 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 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- BDI 10 of higher for dysphoric group
- BDI 5 or lower for healthy control group
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Erasmus University Rotterdam
Rotterdam, South Holland, 3000 DR
About this study
Official title: Working Memory Training to Decrease Depression, Anxiety and Rumination in Dysphoric Students
Depression is associated with impairments in executive functions, including working memory (WM) which is needed to maintain and manipulate goal-relevant information. Due to these WM impairments depressed individuals have difficulties inhibiting and shifting from irrelevant (negative) information and updating goal relevant information. This study explored whether training WM decreases these impairments and reduces clinical symptoms of depression, anxiety and rumination. Sixty-one students with an elevated score on the BDI-II, representing a dysphoric mood state, executed a working memory training (n = 34) or placebo training (n = 27). Before and after training their depression, anxiety, rumination and working memory were assessed. Furthermore, they executed a working memory task while their pupil dilation was measured to assess their fatigue. Moreover, the investigators compared the dysphoric students with a healthy student population on all measures.
- Conditions
- Depression
- Being tested
- Working memory training, Placebo training
- Keywords
- Depression, Anxiety, Working memory, Rumination, Cognitive training, Executive functioning
- Medical subject headings
- Depression, Anxiety Disorders, Rumination Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Working memory trainingBehavioural
Placebo trainingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Working memory training | Experimental | Participants executed the training for three weeks, three times a week, half an hour per session. The training was a game in which the participant was a person who had to become strong to fight with a fantasy figure. The person could become stronger when giving the right answers in eight different working memory tasks. The level adapted to the working memory capacity of the participant. Receives: Behavioral: Working memory training |
| Placebo training | Placebo comparator | Participants executed the training for three weeks, three times a week, half an hour per session. The training was a game in which the participant was a person who had to become strong to fight with a fantasy figure. The person could become stronger when giving the right answers in eight different working memory tasks. The level in the placebo condition was easy and did not adapt to the working memory capacity of the participant. Receives: Behavioral: Placebo training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory Second Edition (BDI-II) score change between pre and post measurement
Depression is measured with the BDI-II
Measured: Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline)
Secondary outcomes (1)
State-Trait Anxiety Inventory (STAI) scores change from pre to post training measurement
The STAI measures state, trait and total anxiety
Measured: Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startSep 2013
- Primary completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- 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, Investigator
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ingmar Franken, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02184481
- Sponsor's protocol ID
- Franken 5
- Status last verified
- Jul 2014
- First submitted
- 3 Jul 2014
- Last updated
- 9 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Hopstaken JF, Wanmaker S, van der Linden D, Bakker AB. Does Dysphoria Lead to Divergent Mental Fatigue Effects on a Cognitive Task? PLoS One. 2015 Jun 15;10(6):e0130304. doi: 10.1371/journal.pone.0130304. eCollection 2015.
PubMed 26075389
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Working Memory Training to Decrease Depression, Anxiety and Rumination in Dysphoric Students
- ClinicalTrials.gov ID
- NCT02184481
- Acronym / sponsor ID
- Franken 5
- Conditions
- Depression
- Keywords
- Depression, Anxiety, Working memory, Rumination, Cognitive training, Executive functioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jun 2014 (actual)
- First posted
- 9 Jul 2014 (estimated)
- 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.
Depression is associated with impairments in executive functions, including working memory (WM) which is needed to maintain and manipulate goal-relevant information. Due to these WM impairments depressed individuals have difficulties inhibiting and shifting from irrelevant (negative) information and updating goal relevant information. This study explored whether training WM decreases these impairments and reduces clinical symptoms of depression, anxiety and rumination. Sixty-one students with an elevated score on the BDI-II, representing a dysphoric mood state, executed a working memory training (n = 34) or placebo training (n = 27). Before and after training their depression, anxiety, rumination and working memory were assessed. Furthermore, they executed a working memory task while their pupil dilation was measured to assess their fatigue. Moreover, the investigators compared the dysphoric students with a healthy student population on all measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Working memory training | Experimental | Behavioral: Working memory trainingParticipants executed the training for three weeks, three times a week, half an hour per session. The training was a game in which the participant was a person who had to become strong to fight with a fantasy figure. The person could become stronger when giving the right answers in eight different working memory tasks. The level adapted to the working memory capacity of the participant. |
| Placebo training | Placebo comparator | Behavioral: Placebo trainingParticipants executed the training for three weeks, three times a week, half an hour per session. The training was a game in which the participant was a person who had to become strong to fight with a fantasy figure. The person could become stronger when giving the right answers in eight different working memory tasks. The level in the placebo condition was easy and did not adapt to the working memory capacity of the participant. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- BDI 10 of higher for dysphoric group
- BDI 5 or lower for healthy control group
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Working memory training | Behavioural | Working memory training |
| Placebo training | Behavioural | Placebo training |
Primary outcome
Beck Depression Inventory Second Edition (BDI-II) score change between pre and post measurement
Time frame: Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline)
Depression is measured with the BDI-II
1 secondary outcome
State-Trait Anxiety Inventory (STAI) scores change from pre to post training measurement
Time frame: Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline)
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 9 Jul 2014.
- Derived from this study: PubMed 26075389Hopstaken JF, Wanmaker S, van der Linden D, Bakker AB. Does Dysphoria Lead to Divergent Mental Fatigue Effects on a Cognitive Task? PLoS One. 2015 Jun 15;10(6):e0130304. doi: 10.1371/journal.pone.0130304. eCollection 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Working memory training in people with Depression, run by Erasmus Medical Center 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 2 inclusion and 0 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 9 Jul 2014. 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. Some participants in this study may receive a placebo. 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?
Beck Depression Inventory Second Edition (BDI-II) score change between pre and post measurement (time frame: Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline)). 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 NCT02184481, which also lists 1 linked publication.
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 9 Jul 2014.