Cognitive Rehabilitation in Patients With Depression

NCT03338413 | Unknown

• 1 other identifier: 2017/666
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• 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

Study Arms (2)

Goal Management Training

EXPERIMENTAL

Behavioral: Goal Management Training

Computerized Cognitive Training

EXPERIMENTAL

Behavioral: Computerized Cognitive Training

Interventions

Goal Management Training BEHAVIORAL

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

Goal Management Training

Computerized Cognitive Training BEHAVIORAL

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.

Also known as: Active control condition

Computerized Cognitive Training

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lovisenberg Diakonale Hospital: lead
• University of Oslo: collaborator
• Yale University: collaborator

Study Sites (1)

Lovisenberg Diaconal Hospital

Oslo, Norway

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Andreas Joner

  Lovisenberg Diaconal Hospital

  STUDY DIRECTOR

Central Study Contacts

Jan Stubberud, ph.d

CONTACT

95104217; jan.stubberud@hotmail.com

Bjørn Hagen, cand.psychol

CONTACT

91301061; BjornOleIngulfsvann.Hagen@lds.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2017
• First Posted: November 9, 2017
• Study Start: January 1, 2018
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: November 14, 2017

Record last verified: 2017-11

Locations

NO (1)