Major DepressionNCT02119923
Tackling Depression and Anxiety: A Working Memory Intervention
A study testing Working memory training in people with Major Depression and Anxiety Disorder, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
Anxiety and depression are both associated with impairments in executive functions, including working memory (WM) which is needed to maintain and manipulate goal-relevant information. Read more about this study
- Who is it for?
- Ages 16 to 68 years
- Conditions the study is for
- Major Depression, Anxiety Disorder
- 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
- 240 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2011to Oct 2011
- 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 16 to 68 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Major depression diagnosis
- Anxiety disorder diagnosis
Who cannot join
- Current psychosis
- Current substance dependency
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Erasmus University Rotterdam
Rotterdam, South Holland, 3000 DR
About this study
Official title: Effects of Working Memory Training in a Depressed and Anxious Sample
Anxiety and depression are both 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 anxious and 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 and rumination. Eighty-four individuals diagnosed with major depression and forty-nine individuals with an anxiety diagnosis executed WM or control tasks three times a week, during four weeks. Before, after training and at a two months follow-up measurement depression and anxiety symptoms, WM capacity and rumination behaviour were assessed. Training WM did only result in a reduction of anxiety symptoms in the depression group. These findings are inconsistent with promising results of individual studies showing training WM result in an enlarged WM capacity and a decrease of psychopathological symptoms. However, our results are in line with recent meta-analyses and reviews which show that WM training do not lead to generalized effects and therefore, doubt the clinical relevance of WM training programs.
- Conditions
- Major Depression, Anxiety Disorder
- Being tested
- Working memory training, Placebo training
- Keywords
- Depression, Anxiety, Working memory, Rumination, Cognitive training, Executive functioning
- Medical subject headings
- Depressive Disorder, Major, Anxiety Disorders, Depression, Rumination Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Working memory trainingBehavioural
The WM consisted of two tasks; the Number-letter task (Rogers \& Monsell, 1995) and an Updating task. The Number-letter task trains the ability to shift between task relevant stimuli. Participants need to shift between four categories. In the Updating task participants receive a set of three words in which they have to compare the two consecutive words on emotional valence (positive or negative) to train their updating skills. Participants executed the training three times a week during four weeks.
Placebo trainingBehavioural
Both the WM and the placebo training consisted of two tasks; the Number-letter task (Rogers \& Monsell, 1995) and an Updating task. To prevent training WM the placebo training was a simplified version of the Number-letter task in which shifting was not required. In the Updating task the placebo group only had to count the number of positive or negative words. Participants executed the training three times a week during four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Working memory training | Experimental | Not described Receives: Behavioral: Working memory training |
| Placebo training | Placebo comparator | Not described 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 training and at follow-up measurement (2 months after 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) and follow-up (2 months after post-test)
Secondary outcomes (1)
State-Trait Anxiety Inventory (STAI) scores change from pre to post training and to follow up measurement (2 months after post 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) and follow-up (2 months after post-test)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2014 (estimated)
- Study startApr 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major 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
- 240 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
- Investigators
- Elke Geraerts, PhD, Principal investigator, Erasmus University RotterdamSabine Wanmaker, MSc, Study director, Erasmus University Rotterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02119923
- Sponsor's protocol ID
- 1
- Status last verified
- Apr 2014
- First submitted
- 8 Apr 2014
- Last updated
- 22 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Working Memory Training in a Depressed and Anxious Sample
- ClinicalTrials.gov ID
- NCT02119923
- Acronym / sponsor ID
- 1
- Conditions
- Major Depression, Anxiety Disorder
- Keywords
- Depression, Anxiety, Working memory, Rumination, Cognitive training, Executive functioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 22 Apr 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.
Anxiety and depression are both 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 anxious and 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 and rumination. Eighty-four individuals diagnosed with major depression and forty-nine individuals with an anxiety diagnosis executed WM or control tasks three times a week, during four weeks. Before, after training and at a two months follow-up measurement depression and anxiety symptoms, WM capacity and rumination behaviour were assessed. Training WM did only result in a reduction of anxiety symptoms in the depression group. These findings are inconsistent with promising results of individual studies showing training WM result in an enlarged WM capacity and a decrease of psychopathological symptoms. However, our results are in line with recent meta-analyses and reviews which show that WM training do not lead to generalized effects and therefore, doubt the clinical relevance of WM training programs.
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 training |
| Placebo training | Placebo comparator | Behavioral: Placebo training |
Who may qualify
- Ages
- 16 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Major depression diagnosis
- Anxiety disorder diagnosis
Key exclusion criteria (2 listed)
- Current psychosis
- Current substance dependency
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 trainingThe WM consisted of two tasks; the Number-letter task (Rogers \& Monsell, 1995) and an Updating task. The Number-letter task trains the ability to shift between task relevant stimuli. Participants need to shift between four categories. In the Updating task participants receive a set of three words in which they have to compare the two consecutive words on emotional valence (positive or negative) to train their updating skills. Participants executed the training three times a week during four weeks. | Behavioural | Working memory training |
| Placebo trainingBoth the WM and the placebo training consisted of two tasks; the Number-letter task (Rogers \& Monsell, 1995) and an Updating task. To prevent training WM the placebo training was a simplified version of the Number-letter task in which shifting was not required. In the Updating task the placebo group only had to count the number of positive or negative words. Participants executed the training three times a week during four weeks. | Behavioural | Placebo training |
Primary outcome
Beck Depression Inventory Second Edition (BDI-II) score change between pre and post training and at follow-up measurement (2 months after post measurement)
Time frame: Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
Depression is measured with the BDI-II
1 secondary outcome
State-Trait Anxiety Inventory (STAI) scores change from pre to post training and to follow up measurement (2 months after post measurement)
Time frame: Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
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 22 Apr 2014.
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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.
Elke Geraerts, PhD principal investigator
Erasmus University Rotterdam
Sabine Wanmaker, MSc study director
Erasmus University Rotterdam
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 Major Depression and Anxiety Disorder, 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 2 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 22 Apr 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 training and at follow-up measurement (2 months after post measurement) (time frame: Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2014.