Cognitive Rehabilitation in Patients With Depression

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03338413
• Other study ID #: 2017/666
• Status: Not yet recruiting
• Phase: N/A
• First received: November 7, 2017
• Last updated: November 13, 2017
• Start date: January 2018
• Est. completion date: June 2020

Study information

• Verified date: November 2017
• Source: Lovisenberg Diakonale Hospital
• Contact: Jan Stubberud, ph.d
• Phone: 95104217
• Email: jan.stubberud[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
Norway	Lovisenberg Diaconal Hospital	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
Lovisenberg Diakonale Hospital	University of Oslo, Yale University

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Performance on Conners Continuous Performance test III incl. CATA		change from baseline up to 6 months
Secondary	Performance on Wisconsin Card Sorting Test		change from baseline up to 6 months
Secondary	Performance on D-KEFS Color Word Interference Test		change from baseline up to 6 months
Secondary	Performance on The Emotional Stroop		change from baseline up to 6 months
Secondary	Performance on the Emo 1-back task		change from baseline up to 6 months
Secondary	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
Secondary	Score on Goal Attainment Scaling (GAS)		change from baseline up to 6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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