Clinical trial NCT03338413: Cognitive Rehabilitation in Patients With Depression
Official title: Cognitive Rehabilitation in Patients With Active and Remitted Depression - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Keywords: Rehabilitation
Lead sponsor: Lovisenberg Diakonale Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
name: Yale University
First posted: 2017-11-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Behavior Rating Inventory of Executive Function (BRIEF: self and informant form)
timeFrame: Change from baseline up to 6 months
Secondary outcomes:
measure: Performance on Conners Continuous Performance test III incl. CATA
timeFrame: change from baseline up to 6 months
measure: Performance on Wisconsin Card Sorting Test
timeFrame: change from baseline up to 6 months
measure: Performance on D-KEFS Color Word Interference Test
timeFrame: change from baseline up to 6 months
measure: Performance on The Emotional Stroop
timeFrame: change from baseline up to 6 months
measure: Performance on the Emo 1-back task
timeFrame: change from baseline up to 6 months
measure: Score on Cognitive Failures Questionnaire (CFQ)
timeFrame: change from baseline up to 6 months
measure: Score on Goal Attainment Scaling (GAS)
timeFrame: change from baseline up to 6 months
measure: Score on Beck Depression Inventory II (BDI-II)
timeFrame: change from baseline up to 6 months
measure: Score on Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM)
timeFrame: change from baseline up to 6 months
measure: Score on General Perceived Self-Efficacy Scale
timeFrame: change from baseline up to 6 months
measure: Score on Return to Work Self-Efficacy Scale (RTW-SE)
timeFrame: change from baseline up to 6 months
measure: Score on Difficulties in Emotion Regulation Scale (DERS)
timeFrame: change from baseline up to 6 months
measure: Score on The Ruminative Response Scale (RRS)
timeFrame: change from baseline up to 6 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Lovisenberg Diaconal Hospital
Study officials:
affiliation: Lovisenberg Diaconal Hospital
name: Andreas Joner
role: STUDY_DIRECTOR
References: