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Clinical Trials/NCT03338413
NCT03338413
Unknown
Not Applicable

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

Lovisenberg Diakonale Hospital1 site in 1 country100 target enrollmentJanuary 2018
ConditionsDepression

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
Lovisenberg Diakonale Hospital
Enrollment
100
Locations
1
Primary Endpoint
Behavior Rating Inventory of Executive Function (BRIEF: self and informant form)
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2018
End Date
June 2020
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Lovisenberg Diakonale Hospital
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Behavior Rating Inventory of Executive Function (BRIEF: self and informant form)

Time Frame: Change from baseline up to 6 months

Executive function in daily life (range:70-210). Higher score indicate greater executive dysfunction.

Secondary Outcomes

  • Performance on D-KEFS Color Word Interference Test(change from baseline up to 6 months)
  • Score on Goal Attainment Scaling (GAS)(change from baseline up to 6 months)
  • Performance on Conners Continuous Performance test III incl. CATA(change from baseline up to 6 months)
  • Performance on Wisconsin Card Sorting Test(change from baseline up to 6 months)
  • Performance on The Emotional Stroop(change from baseline up to 6 months)
  • Performance on the Emo 1-back task(change from baseline up to 6 months)
  • Score on Cognitive Failures Questionnaire (CFQ)(change from baseline up to 6 months)
  • Score on Beck Depression Inventory II (BDI-II)(change from baseline up to 6 months)
  • Score on Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM)(change from baseline up to 6 months)
  • Score on General Perceived Self-Efficacy Scale(change from baseline up to 6 months)
  • Score on Return to Work Self-Efficacy Scale (RTW-SE)(change from baseline up to 6 months)
  • Score on Difficulties in Emotion Regulation Scale (DERS)(change from baseline up to 6 months)
  • Score on The Ruminative Response Scale (RRS)(change from baseline up to 6 months)

Study Sites (1)

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