Major Depressive DisorderRIDEMNCT03624621
Integral Remediation for Major Depression ("Rehabilitación Integral Para la Depresión Mayor", RIDEM)
A study testing Functional Remediation, Computerized Cognitive Training (CCT) and Psychoeducation in people with Major Depressive Disorder and Cognitive Symptom, run by Hospital de Sant Pau at 1 site in Spain.
Trial summary
Available pharmacological and psychotherapeutic treatments are not effective for the treatment of cognitive symptoms of major depressive disorder (MDD). More recent studies have described that functional disability and the indirect costs of MDD (e.g., sick leaves at work, decreased productivity, ...) are related to… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Major Depressive Disorder, Cognitive Symptom
- What is being tested?
- Functional Remediation, Computerized Cognitive Training (CCT) and Psychoeducation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteSpain
- Study dates
- 15 Mar 2018to 31 Dec 2020
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18 and 60 years (males and females)
- diagnosis of Major Depression (criteria Diagnostic and Statistical Manual 5th edition, DSM-5) in Remission or Partial Remission phase (scores below 14 in the Hamilton Depression Rating Scale-17 items (HDRS-17))
- Cognitive Symptoms (-1.5SD (standar deviation) in objective as subjective tests),
- PDQ > 20
- FAST> 17
Who cannot join
- Intelligence Quotient (IQ) < 85
- Any medical condition that may affect cognition
- Presence of any comorbid psychiatric condition (including abuse or dependence on substances in the last three months)
- Electroconvulsive therapy (ECT) in the previous year
- Other psychological intervention in the 6 months prior to the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RIDEM Integral Remediation for Major Depression. Efficacy Study of a Functional Remediation Program and Cognitive Training
Available pharmacological and psychotherapeutic treatments are not effective for the treatment of cognitive symptoms of major depressive disorder (MDD). More recent studies have described that functional disability and the indirect costs of MDD (e.g., sick leaves at work, decreased productivity, ...) are related to persistent cognitive deficits. Some programs of cognitive rehabilitation and cognitive training (developed for other pathologies) have been tested, but the results are inconsistent.
There is an imperative need to develop a specific comprehensive rehabilitation program for MDD that includes the benefits of traditional functional remediation (FR) and computerized cognitive training (CCT) programs adjusted for each patient's cognitive deficit.
Read the detailed description
Objectives: To develop the Integral Rehabilitation Program (FR + CCT) and to demonstrate its efficacy in cognitive and functional remission (i.e. global remission) of patients with MDD in clinical remission.
Methodology: The project will consist of two stages:
- - Development and adaptation of the Integral Rehabilitation program for MD, based on the program developed for bipolar disorder, and including a computerized cognitive training adjusted to the neuropsychological profile of each patient;
- - A clinical trial, randomized, blind evaluator, with three intervention arms: INTEGRAL REHABILITATION (FR + CCT); PSYCHOEDUCATION + online games; and TREATMENT AS USUAL.
Sample size will be a total of 90 patients with MDD in remission (full or partial).
- Conditions
- Major Depressive Disorder, Cognitive Symptom
- Being tested
- Functional Remediation, Computerized Cognitive Training (CCT), Psychoeducation, Online games
- Keywords
- Major Depressive Disorder, Cognitive Remediation, Functioning, Full Recovery, Functional Remediation
- Medical subject headings
- Depressive Disorder, Major, Neurobehavioral Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional RemediationBehavioural
Also called Cognitive Remediation
Functional remediation includes directed group sessions tapping into the main cognitive domains affected in depression (executive functioning, attention and memory) as well as their implication in daily living.
Computerized Cognitive Training (CCT)Device
Also called CogniFit (registered brand)
12 add-on sessions (20-minute long) after each group session to train cognitive domains.
PsychoeducationBehavioural
Also called Group sessions
12 sessions of psychoeducation on depression, providing information about the disease, causes, consequences and other useful data for the management of depression.
Online gamesDevice
Also called friv.com
Participants play non-directed online games during 20 minutes after each psychoeducation grup session to make the two active intervention more similar.
| Study group | Role | What they receive |
|---|---|---|
| Functional Remediation + CCT | Experimental | 12 sessions (1 per week) of group functional remediation program (90 min/session) plus 20 min of tailored computerized cognitive training (CCT) Receives: Behavioral: Functional Remediation; Device: Computerized Cognitive Training (CCT) |
| Psychoeducation + Online Games | Placebo comparator | 12 sessions (1 per week) of psychoeducation for major depression (90 min/session) plus 20 min of playing freely with online games (pre-selected by investigators) Receives: Behavioral: Psychoeducation; Device: Online games |
| Treatment as usual | No intervention | Usual intervention supervised by their psychiatrist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Functioning Assessment Short Test (FAST) score at 6 and 15 months
Assessment of daily functioning of depressed patients, including economics, cognition, social relationships, leisure and personal care
Measured: 3 and 12 months after intervention
Secondary outcomes (1)
Change from baseline perceived cognitive deficits (PDQ)
Self-appraisal of cognitive functioning
Measured: 3 and 12 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start15 Mar 2018
- Primary completion31 Oct 2020
- Study completion31 Dec 2020
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 Major Depressive DisorderStudies 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
- Model description
- Randomized single-blind and controlled clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Sant Pau
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Principal investigator, Maria J Portella, Hospital de Sant Pau
- Investigators
- Maria J Portella, Dr, Principal investigator, IBB-Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03624621
- Sponsor's protocol ID
- IIBSP-rid-2017-107
- Acronym
- RIDEM
- Status last verified
- Aug 2022
- First submitted
- 1 Aug 2018
- Last updated
- 30 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Coded database for meta-analysis of cognitive symptoms in MDD (via international consortiums)
Publications
Vicent-Gil M, Raventos B, Marin-Martinez ED, Gonzalez-Simarro S, Martinez-Aran A, Bonnin CDM, Trujols J, Perez-Blanco J, de Diego-Adelino J, Puigdemont D, Serra-Blasco M, Cardoner N, Portella MJ. Testing the efficacy of INtegral Cognitive REMediation (INCREM) in major depressive disorder: study protocol for a randomized clinical trial. BMC Psychiatry. 2019 May 6;19(1):135. doi: 10.1186/s12888-019-2117-4.
PubMed 31060604
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RIDEM Integral Remediation for Major Depression. Efficacy Study of a Functional Remediation Program and Cognitive Training
- ClinicalTrials.gov ID
- NCT03624621
- Acronym / sponsor ID
- RIDEM / IIBSP-rid-2017-107
- Conditions
- Major Depressive Disorder, Cognitive Symptom
- Keywords
- Major Depressive Disorder, Cognitive Remediation, Functioning, Full Recovery, Functional Remediation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Hospital de Sant PauUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 10 Aug 2018 (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.
Available pharmacological and psychotherapeutic treatments are not effective for the treatment of cognitive symptoms of major depressive disorder (MDD). More recent studies have described that functional disability and the indirect costs of MDD (e.g., sick leaves at work, decreased productivity, ...) are related to persistent cognitive deficits. Some programs of cognitive rehabilitation and cognitive training (developed for other pathologies) have been tested, but the results are inconsistent.
There is an imperative need to develop a specific comprehensive rehabilitation program for MDD that includes the benefits of traditional functional remediation (FR) and computerized cognitive training (CCT) programs adjusted for each patient's cognitive deficit.
Detailed description
Objectives: To develop the Integral Rehabilitation Program (FR + CCT) and to demonstrate its efficacy in cognitive and functional remission (i.e. global remission) of patients with MDD in clinical remission.
Methodology: The project will consist of two stages:
- - Development and adaptation of the Integral Rehabilitation program for MD, based on the program developed for bipolar disorder, and including a computerized cognitive training adjusted to the neuropsychological profile of each patient;
- - A clinical trial, randomized, blind evaluator, with three intervention arms: INTEGRAL REHABILITATION (FR + CCT); PSYCHOEDUCATION + online games; and TREATMENT AS USUAL.
Sample size will be a total of 90 patients with MDD in remission (full or partial).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized single-blind and controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Functional Remediation + CCT | Experimental | Behavioral: Functional Remediation, Device: Computerized Cognitive Training (CCT)12 sessions (1 per week) of group functional remediation program (90 min/session) plus 20 min of tailored computerized cognitive training (CCT) |
| Psychoeducation + Online Games | Placebo comparator | Behavioral: Psychoeducation, Device: Online games12 sessions (1 per week) of psychoeducation for major depression (90 min/session) plus 20 min of playing freely with online games (pre-selected by investigators) |
| Treatment as usual | No intervention | –Usual intervention supervised by their psychiatrist |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18 and 60 years (males and females)
- diagnosis of Major Depression (criteria Diagnostic and Statistical Manual 5th edition, DSM-5) in Remission or Partial Remission phase (scores below 14 in the Hamilton Depression Rating Scale-17 items (HDRS-17))
- Cognitive Symptoms (-1.5SD (standar deviation) in objective as subjective tests),
- PDQ > 20
- FAST> 17
Key exclusion criteria (5 listed)
- Intelligence Quotient (IQ) < 85
- Any medical condition that may affect cognition
- Presence of any comorbid psychiatric condition (including abuse or dependence on substances in the last three months)
- Electroconvulsive therapy (ECT) in the previous year
- Other psychological intervention in the 6 months prior to the study.
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 |
|---|---|---|
| Functional RemediationAlso: Cognitive RemediationFunctional remediation includes directed group sessions tapping into the main cognitive domains affected in depression (executive functioning, attention and memory) as well as their implication in daily living. | Behavioural | Functional Remediation + CCT |
| Computerized Cognitive Training (CCT)Also: CogniFit (registered brand)12 add-on sessions (20-minute long) after each group session to train cognitive domains. | Device | Functional Remediation + CCT |
| PsychoeducationAlso: Group sessions12 sessions of psychoeducation on depression, providing information about the disease, causes, consequences and other useful data for the management of depression. | Behavioural | Psychoeducation + Online Games |
| Online gamesAlso: friv.comParticipants play non-directed online games during 20 minutes after each psychoeducation grup session to make the two active intervention more similar. | Device | Psychoeducation + Online Games |
Primary outcome
Change from baseline Functioning Assessment Short Test (FAST) score at 6 and 15 months
Time frame: 3 and 12 months after intervention
Assessment of daily functioning of depressed patients, including economics, cognition, social relationships, leisure and personal care
1 secondary outcome
Change from baseline perceived cognitive deficits (PDQ)
Time frame: 3 and 12 months after intervention
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 30 Aug 2022.
- Derived from this study: PubMed 31060604Vicent-Gil M, Raventos B, Marin-Martinez ED, Gonzalez-Simarro S, Martinez-Aran A, Bonnin CDM, Trujols J, Perez-Blanco J, de Diego-Adelino J, Puigdemont D, Serra-Blasco M, Cardoner N, Portella MJ. Testing the efficacy of INtegral Cognitive REMediation (INCREM) in major depressive disorder: study protocol for a randomized clinical trial. BMC Psychiatry. 2019 May 6;19(1):135. doi: 10.1186/s12888-019-2117-4.
- Individual participant dataSharing planned: Undecided. Coded database for meta-analysis of cognitive symptoms in MDD (via international consortiums)
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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.
Maria J Portella, Dr principal investigator
IBB-Sant Pau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Remediation, Computerized Cognitive Training (CCT) and Psychoeducation in people with Major Depressive Disorder and Cognitive Symptom, run by Hospital de Sant Pau at 1 site in Spain.
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 5 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 30 Aug 2022. 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 Spain. 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 from baseline Functioning Assessment Short Test (FAST) score at 6 and 15 months (time frame: 3 and 12 months after intervention). 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 NCT03624621, 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 30 Aug 2022.