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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INCREM | Experimental | 12-session integral cognitive remediation program specifically designed for depression. |
|
| Psychoeducation | Active Comparator | 12-session psychoeducation program for depression |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INCREM | Behavioral | This is a specifically designed program to improve psychosocial functioning which targets cognitive symptoms. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of treatment (12 weeks) and to the end of follow-up (6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of treatment (12 weeks) and to the end of follow-up (6 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria J Portella, Dr | Fundació Institut de Recerca Hospital de la Santa Creu i Sant Pau | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Recerca Sant Pau- Mental Health Group | Barcelona | Catalonia | 08041 | Spain |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D019954 | Neurobehavioral Manifestations |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D000072466 | Cognitive Remediation |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Psychoeducation | Behavioral | This is a 12-session psychoeducation program designed as an active comparator for the current trial |
|
| 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. |
| 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. | From enrollment to the end of the intervention (12 weeks) and to the end of follow-up (6 months) |
| D009422 |
| Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |