Major DepressionNCT02119975
A Working Memory Training to Decrease Rumination in Depressed and Anxious Individuals
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
Dysfunctioning executive functioning, including working memory (WM), is related to rumination. Findings show that working memory capacity (WMC) can be increased by training. The current study explored by means of a double-blind randomized controlled trial whether an adaptive WM training could reduce rumination… Read more about this study
- Who is it for?
- Ages 18 to 67 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
- 98 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2011to Dec 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 18 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major depression diagnosis
- Anxiety diagnosis
Who cannot join
- Current psychosis
- Substance abuse
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Erasmus University Rotterdam
Rotterdam, South Holland, 3000 DR
About this study
Official title: A Working Memory Training to Decrease Rumination in Depressed and Anxious Individuals: A Double-blind Randomized Controlled Trial
Dysfunctioning executive functioning, including working memory (WM), is related to rumination. Findings show that working memory capacity (WMC) can be increased by training. The current study explored by means of a double-blind randomized controlled trial whether an adaptive WM training could reduce rumination, anxiety and depression in a sample of 98 depressed and anxious individuals.
- Conditions
- Major Depression, Anxiety Disorder
- Being tested
- Working memory training, Placebo training
- Keywords
- Rumination, Working memory, Depression, Anxiety, Working memory training, Overgeneral memories
- Medical subject headings
- Depressive Disorder, Major, Anxiety Disorders, Rumination Syndrome, Depression
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 |
|---|---|---|
| Placebo working memory training | Placebo comparator | Not described Receives: Behavioral: Placebo training |
| Working memory training | Experimental | Not described Receives: Behavioral: Working memory training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Ruminative Response Scale (RRS) score from pre to post training and after two months (follow up 2)
Dutch version; Raes, Hermans, \& Eelen, 2003) measures the frequency of self-reported rumination behavior, with answer options ranging from 1 (never) to 4 (always). The total score of the 22 items was used in the analyses.
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 (2)
Change in Beck Depression Inventory Second Edition (BDI-II) score from pre to post training and after two months (follow up 2)
The Beck Depression Inventory - II (BDI-II; Beck, Steer, \& Brown, 1996; Dutch version: Van der Does, 2002) measures the severity of depression symptoms of the last two weeks.
Measured: Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
Change in State-Trait Anxiety Inventory (STAI) score from pre to post training and after two months (follow up 2)
The State-Trait Anxiety Inventory (STAI; Spielberger, Gorsuch, Lushene, Vagg, \& Jacobs, 1983, Dutch version; Van der Ploeg, Defares, \& Spielberger, 1979) measures self-reported anxiety, divided in state anxiety and trait 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 startAug 2011
- Primary completionDec 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
- 98 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
- NCT02119975
- Sponsor's protocol ID
- 4
- Status last verified
- Apr 2014
- First submitted
- 8 Apr 2014
- Last updated
- 22 Apr 2014
- Results posted
- No
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
- A Working Memory Training to Decrease Rumination in Depressed and Anxious Individuals: A Double-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02119975
- Acronym / sponsor ID
- 4
- Conditions
- Major Depression, Anxiety Disorder
- Keywords
- Rumination, Working memory, Depression, Anxiety, Working memory training, Overgeneral memories
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Dec 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.
Dysfunctioning executive functioning, including working memory (WM), is related to rumination. Findings show that working memory capacity (WMC) can be increased by training. The current study explored by means of a double-blind randomized controlled trial whether an adaptive WM training could reduce rumination, anxiety and depression in a sample of 98 depressed and anxious individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo working memory training | Placebo comparator | Behavioral: Placebo training |
| Working memory training | Experimental | Behavioral: Working memory training |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Major depression diagnosis
- Anxiety diagnosis
Key exclusion criteria (2 listed)
- Current psychosis
- Substance abuse
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 working memory training |
Primary outcome
Change in Ruminative Response Scale (RRS) score from pre to post training and after two months (follow up 2)
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)
Dutch version; Raes, Hermans, \& Eelen, 2003) measures the frequency of self-reported rumination behavior, with answer options ranging from 1 (never) to 4 (always). The total score of the 22 items was used in the analyses.
2 secondary outcomes
Change in Beck Depression Inventory Second Edition (BDI-II) score from pre to post training and after two months (follow up 2)
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)
Change in State-Trait Anxiety Inventory (STAI) score from pre to post training and after two months (follow up 2)
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.
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 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?
Change in Ruminative Response Scale (RRS) score from pre to post training and after two months (follow up 2) (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; AzTrials last refreshed its copy on 27 Oct 2026.