Skip to content

Cognitive Rehabilitation in Patients With Depression

Cognitive Rehabilitation in Patients With Active and Remitted Depression - a Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03338413
Enrollment
100
Registered
2017-11-09
Start date
2018-01-31
Completion date
2020-06-30
Last updated
2017-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

Rehabilitation

Brief summary

Depression is a highly prevalent and debilitating mental disorder, ranked one of the leading causes of disability worldwide. Several studies have identified neuropsychological deficits in populations of depressed patients affecting domains including attention, memory and executive functioning. These deficits often persist even in patients whose depressive symptoms have remitted. Cognitive impairment in depression represent a core feature of depression, and a valuable target for intervention. Identification of methods that would lead to amelioration would be of great clinical interest, and cognitive rehabilitation (CR) could be a potential way of achieving this. To date few studies on cognitive rehabilitation in depression has been conducted, but the preliminary results are promising. Still the demonstration of long-term effects and evidence relating to improved daily life executive functioning (i.e., generalization) is lacking. In the present study different group-based cognitive rehabilitation interventions will be compared. The aim of the study is to investigate if a group-based brain training intervention can improve executive function in patients with active and remitted depression. Efficacy will be assessed immediately after intervention, but also six months after the intervention.

Interventions

9 GMT modules will be administered in 9X2 hour sessions (ten groups). Manualized intervention; metacognitive strategies for improving attention and problem solving.

BEHAVIORALComputerized Cognitive Training

9 modules will be administered in 9x1 hour session (ten groups). Computerized Cognitive Training using commercially available web-based platforms based on neuroplasticity, developed to target skills such as attention, memory, speed of processing and executive functioning. Homework assignment between sessions.

Sponsors

University of Oslo
CollaboratorOTHER
Yale University
CollaboratorOTHER
Lovisenberg Diakonale Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

* Completed treatment for mild or moderate MDD * Evidence of executive dysfunction in everyday life determined by (a) a structured interview or (b) a self-report Behavior Rating Inventory of Executive Function (BRIEF) T-score \< 55.

Exclusion criteria

* Cognitive, sensory, physical, or language impairment affecting the capacity to complete the training program. * Premorbid neurological disease or insult and/or comorbid neurological disorder. * Reported ongoing alcohol or substance abuse. * Psychotic disorders. * Actively suicidal. * Personality disorder sever enough to interfere with the protocol. * Not fluent in Norwegian language.

Design outcomes

Primary

MeasureTime frameDescription
Behavior Rating Inventory of Executive Function (BRIEF: self and informant form)Change from baseline up to 6 monthsExecutive function in daily life (range:70-210). Higher score indicate greater executive dysfunction.

Secondary

MeasureTime frameDescription
Performance on Wisconsin Card Sorting Testchange from baseline up to 6 months
Performance on D-KEFS Color Word Interference Testchange from baseline up to 6 months
Performance on The Emotional Stroopchange from baseline up to 6 months
Performance on the Emo 1-back taskchange from baseline up to 6 months
Score on Cognitive Failures Questionnaire (CFQ)change from baseline up to 6 monthsAssess frequency of cognitive failures (range:0-100). Higher Score indicate more frequent cognitive failures.
Score on Goal Attainment Scaling (GAS)change from baseline up to 6 months
Performance on Conners Continuous Performance test III incl. CATAchange from baseline up to 6 months
Score on Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM)change from baseline up to 6 monthsAssess the level of current psychological distress (range:0-136). Higher score indicate higher level of distress.
Score on General Perceived Self-Efficacy Scalechange from baseline up to 6 monthsAssess a general sense of perceived self-efficacy (range:10-40). Higher score indicate higher self-efficacy.
Score on Return to Work Self-Efficacy Scale (RTW-SE)change from baseline up to 6 monthsAssess self-efficacy in the Return to work context (range:0-55). Higher score indicate higher self-efficacy.
Score on Difficulties in Emotion Regulation Scale (DERS)change from baseline up to 6 monthsHigher score indicate a higher level of difficulties in emotion regulation (range:36-180).
Score on The Ruminative Response Scale (RRS)change from baseline up to 6 monthsHigher score indicate a higher level of ruminative responses (range: 22-88).
Score on Beck Depression Inventory II (BDI-II)change from baseline up to 6 monthsHigher score indicate a higher level of depression (range: 0-63).

Countries

Norway

Contacts

Primary ContactJan Stubberud, ph.d
jan.stubberud@hotmail.com95104217
Backup ContactBjørn Hagen, cand.psychol
BjornOleIngulfsvann.Hagen@lds.no91301061

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026