Major Depressive Disorder (MDD)INCREMNCT07014683
Integral Cognitive Remediation for Depression
A study testing INCREM and Psychoeducation in people with Major Depressive Disorder (MDD), run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
The goal of this clinical trial is to learn if INCREM intervention can improve psychosocial functioning in patients with remitted major depressive disorder. The main question it aims to answer are: Does INCREM improve psychosocial functioning compared to psychoeducation? Does the benefits of INCREM remain after six… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- INCREM and Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteSpain
- Study dates
- 19 Sep 2021to 13 Aug 2023
- 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
- Patients aged 18-60 y.o. and beyond with a remitted or active episode of major depression (DSM-5 criteria; maximum score of 18-20 on the HDRS-17) showing cognitive symptoms (scores below 80 on the SCIP) with functional difficulties (scores above 12 on the FAST).
Who cannot join
- IQ below 85;
- any unstable or inadequately-treated medical condition that may affect neuropsychological performance;
- being under drug treatment in the last 4 weeks with glucocorticoids, probiotics, non-steroidal anti-inflammatory drugs, bile acid sequestrants, immunosuppressive drugs, anti-histamines, mast cell stabilizers, and antioxidant supplements;
- use of systemic antibiotics the last 2 months;
- presence of any comorbid psychiatric condition, other than personality disorders or nicotine use disorders, in the last three months;
- accomplish criteria for severe treatment resistant depression;
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- patients who had received electroconvulsive therapy in the previous year;
- patients receiving any other structured psychological intervention in the 3 months prior to the study;
- not having the necessary electronic means (computer or tablet) or internet connection to be able to participate.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Institut de Recerca Sant Pau- Mental Health Group
Barcelona, Catalonia, 08041
About this study
Official title: INtegral Cognitive REMediation for Depression (INCREM). Multicentric Randomized Clinical Trial to Investigate Feasibility and Efficacy (Phase II)
The goal of this clinical trial is to learn if INCREM intervention can improve psychosocial functioning in patients with remitted major depressive disorder. The main question it aims to answer are:
Does INCREM improve psychosocial functioning compared to psychoeducation? Does the benefits of INCREM remain after six months of the intervention compared to psychoeducation?
Researchers will compare two arms: INCREM; psychoeducation to see if psychosocial functioning improves.
Participants will be allocated to:
- INCREM
- Psychoeducation
- TAU.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- INCREM, Psychoeducation
- Keywords
- cognitive symptoms, cognitive remediation, rehabilitation, functional recovery, major depressive disorder
- 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.
INCREMBehavioural
Also called cognitive remediation
This is a specifically designed program to improve psychosocial functioning which targets cognitive symptoms.
PsychoeducationBehavioural
This is a 12-session psychoeducation program designed as an active comparator for the current trial
| Study group | Role | What they receive |
|---|---|---|
| INCREM | Experimental | 12-session integral cognitive remediation program specifically designed for depression. Receives: Behavioral: INCREM |
| Psychoeducation | Active comparator | 12-session psychoeducation program for depression Receives: Behavioral: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functioning Assessment Short Test (FAST)
The FAST is a valid, widely used instrument to test psychosocial functioning. The main outcome measure will be the percentage of change in FAST scores between T0 and T1 and T2.
Measured: From enrollment to the end of treatment (12 weeks) and to the end of follow-up (6 months)
Secondary outcomes (3)
Hamilton Depression Rating Scale-17 items (HDRS_17)
This scale is used to rate the severity of depression symptoms by probing mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms.
Measured: From enrollment to the end of treatment (12 weeks) and to the end of follow-up (6 months)
Screening for Cognitive Impairment in Psychiatry (SCIP)
The SCIP is a brief and easy-to-administer tool, requiring the test sheet, a clock and a pencil only, specifically targeting psychiatric populations.
Measured: From enrollment to the end of the intervention (12 weeks) and to the end of the follow-up (6 months)
Perceived Deficits Questionnaire for Depression (PDQ-R)
The PDQ-D is a self-reported scale for monitoring cognitive dysfunction in patients with major depression. The PDQ-D is a modified version of the original PDQ, which was developed to assess cognitive symptoms in patients with multiple sclerosis.
Measured: From enrollment to the end of the intervention (12 weeks) and to the end of follow-up (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start19 Sep 2021
- Primary completion13 Aug 2023
- Study completion13 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria J Portella, Dr, Principal investigator, Fundació Institut de Recerca Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07014683
- Sponsor's protocol ID
- IIBSP-RID-2021-07
- Acronym
- INCREM
- Status last verified
- Sep 2024
- First submitted
- 30 May 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INtegral Cognitive REMediation for Depression (INCREM). Multicentric Randomized Clinical Trial to Investigate Feasibility and Efficacy (Phase II)
- ClinicalTrials.gov ID
- NCT07014683
- Acronym / sponsor ID
- INCREM / IIBSP-RID-2021-07
- Conditions
- Major Depressive Disorder (MDD)
- Keywords
- cognitive symptoms, cognitive remediation, rehabilitation, functional recovery, major depressive disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 19 Sep 2021 (actual)
- Primary completion
- 13 Aug 2023 (actual)
- Study completion
- 13 Aug 2023 (actual)
- First posted
- 11 Jun 2025 (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.
The goal of this clinical trial is to learn if INCREM intervention can improve psychosocial functioning in patients with remitted major depressive disorder. The main question it aims to answer are:
Does INCREM improve psychosocial functioning compared to psychoeducation? Does the benefits of INCREM remain after six months of the intervention compared to psychoeducation?
Researchers will compare two arms: INCREM; psychoeducation to see if psychosocial functioning improves.
Participants will be allocated to:
- INCREM
- Psychoeducation
- TAU.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INCREM | Experimental | Behavioral: INCREM12-session integral cognitive remediation program specifically designed for depression. |
| Psychoeducation | Active comparator | Behavioral: Psychoeducation12-session psychoeducation program for depression |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients aged 18-60 y.o. and beyond with a remitted or active episode of major depression (DSM-5 criteria; maximum score of 18-20 on the HDRS-17) showing cognitive symptoms (scores below 80 on the SCIP) with functional difficulties (scores above 12 on the FAST).
Key exclusion criteria (9 listed)
- IQ below 85;
- any unstable or inadequately-treated medical condition that may affect neuropsychological performance;
- being under drug treatment in the last 4 weeks with glucocorticoids, probiotics, non-steroidal anti-inflammatory drugs, bile acid sequestrants, immunosuppressive drugs, anti-histamines, mast cell stabilizers, and antioxidant supplements;
- use of systemic antibiotics the last 2 months;
- presence of any comorbid psychiatric condition, other than personality disorders or nicotine use disorders, in the last three months;
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 |
|---|---|---|
| INCREMAlso: cognitive remediationThis is a specifically designed program to improve psychosocial functioning which targets cognitive symptoms. | Behavioural | INCREM |
| PsychoeducationThis is a 12-session psychoeducation program designed as an active comparator for the current trial | Behavioural | Psychoeducation |
Primary outcome
Functioning Assessment Short Test (FAST)
Time frame: From enrollment to the end of treatment (12 weeks) and to the end of follow-up (6 months)
The FAST is a valid, widely used instrument to test psychosocial functioning. The main outcome measure will be the percentage of change in FAST scores between T0 and T1 and T2.
3 secondary outcomes
Hamilton Depression Rating Scale-17 items (HDRS_17)
Time frame: From enrollment to the end of treatment (12 weeks) and to the end of follow-up (6 months)
Screening for Cognitive Impairment in Psychiatry (SCIP)
Time frame: From enrollment to the end of the intervention (12 weeks) and to the end of the follow-up (6 months)
Perceived Deficits Questionnaire for Depression (PDQ-R)
Time frame: From enrollment to the end of the intervention (12 weeks) and to the end of follow-up (6 months)
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 11 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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
Fundació Institut de Recerca Hospital de la Santa Creu i 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 INCREM and Psychoeducation in people with Major Depressive Disorder (MDD), run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i 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 1 inclusion and 9 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 11 Jun 2025. 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. 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?
Functioning Assessment Short Test (FAST) (time frame: From enrollment to the end of treatment (12 weeks) and to the end of follow-up (6 months)). 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 11 Jun 2025.