Cognitive Rehabilitation in Patients With Depression

Not Applicable

• Conditions: Depression
• Interventions: Behavioral: Computerized Cognitive Training; Behavioral: Goal Management Training

• Registration Number: NCT03338413
• Lead Sponsor: Lovisenberg Diakonale Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-11
• Study First Submitted: 2017-11-07
• Study First Submitted QC: 2017-11-07
• Study First Posted: 2017-11-09
• Last Update Submitted: 2017-11-13
• Last Update Posted: 2017-11-14
• Study Start: 2018-01
• Primary Completion: 2020-06
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Computerized Cognitive Training	Computerized Cognitive Training	-
Goal Management Training	Goal Management Training	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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 D-KEFS Color Word Interference 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	Assess 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
Score on Beck Depression Inventory II (BDI-II)	change from baseline up to 6 months	Higher score indicate a higher level of depression (range: 0-63).
Score on Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM)	change from baseline up to 6 months	Assess the level of current psychological distress (range:0-136). Higher score indicate higher level of distress.
Score on General Perceived Self-Efficacy Scale	change from baseline up to 6 months	Assess 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 months	Assess 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 months	Higher 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 months	Higher score indicate a higher level of ruminative responses (range: 22-88).

Trial Locations

Locations (1)

Lovisenberg Diaconal Hospital; 🇳🇴 Oslo, Norway