Cognitive Rehabilitation in Patients With Depression

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

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.

Study Overview

• Status: Unknown
• Conditions: Depression
• Intervention / Treatment: Behavioral: Goal Management Training; Behavioral: Computerized Cognitive Training

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jan Stubberud, ph.d; Phone Number: 95104217; Email: jan.stubberud@hotmail.com
• Study Contact Backup: Name: Bjørn Hagen, cand.psychol; Phone Number: 91301061; Email: BjornOleIngulfsvann.Hagen@lds.no

Study Locations

• Norway
  • Oslo, Norway
    • Lovisenberg Diaconal Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Goal Management Training	Behavioral: Goal Management Training; 9 GMT modules will be administered in 9X2 hour sessions (ten groups). Manualized intervention; metacognitive strategies for improving attention and problem solving.
EXPERIMENTAL: Computerized Cognitive Training	Behavioral: Computerized 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.; Other Names: Active control condition

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Assess frequency of cognitive failures (range:0-100). Higher Score indicate more frequent cognitive failures.	change from baseline up to 6 months
Score on Goal Attainment Scaling (GAS)		change from baseline up to 6 months
Score on Beck Depression Inventory II (BDI-II)	Higher score indicate a higher level of depression (range: 0-63).	change from baseline up to 6 months
Score on Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM)	Assess the level of current psychological distress (range:0-136). Higher score indicate higher level of distress.	change from baseline up to 6 months
Score on General Perceived Self-Efficacy Scale	Assess a general sense of perceived self-efficacy (range:10-40). Higher score indicate higher self-efficacy.	change from baseline up to 6 months
Score on Return to Work Self-Efficacy Scale (RTW-SE)	Assess self-efficacy in the Return to work context (range:0-55). Higher score indicate higher self-efficacy.	change from baseline up to 6 months
Score on Difficulties in Emotion Regulation Scale (DERS)	Higher score indicate a higher level of difficulties in emotion regulation (range:36-180).	change from baseline up to 6 months
Score on The Ruminative Response Scale (RRS)	Higher score indicate a higher level of ruminative responses (range: 22-88).	change from baseline up to 6 months

Collaborators and Investigators

• Sponsor: Lovisenberg Diakonale Hospital
• Collaborators: University of Oslo; Yale University
• Investigators: Study Director: Andreas Joner, Lovisenberg Diaconal Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2018
• Primary Completion (ANTICIPATED): June 1, 2020
• Study Completion (ANTICIPATED): June 1, 2020

Study Registration Dates

• First Submitted: November 7, 2017
• First Submitted That Met QC Criteria: November 7, 2017
• First Posted (ACTUAL): November 9, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 14, 2017
• Last Update Submitted That Met QC Criteria: November 13, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Rehabilitation
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: 2017/666

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No