Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cognitive Rehabilitation in Patients With Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03338413
Recruitment Status : Not yet recruiting
First Posted : November 9, 2017
Last Update Posted : November 14, 2017
Sponsor:
Collaborators:
University of Oslo
Yale University
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Goal Management Training Behavioral: Computerized Cognitive Training Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cognitive Rehabilitation in Patients With Active and Remitted Depression - a Randomized Controlled Trial
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

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 Name: Active control condition




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


Secondary Outcome Measures :
  1. Performance on Conners Continuous Performance test III incl. CATA [ Time Frame: change from baseline up to 6 months ]
  2. Performance on Wisconsin Card Sorting Test [ Time Frame: change from baseline up to 6 months ]
  3. Performance on D-KEFS Color Word Interference Test [ Time Frame: change from baseline up to 6 months ]
  4. Performance on The Emotional Stroop [ Time Frame: change from baseline up to 6 months ]
  5. Performance on the Emo 1-back task [ Time Frame: change from baseline up to 6 months ]
  6. Score on Cognitive Failures Questionnaire (CFQ) [ Time Frame: change from baseline up to 6 months ]
    Assess frequency of cognitive failures (range:0-100). Higher Score indicate more frequent cognitive failures.

  7. Score on Goal Attainment Scaling (GAS) [ Time Frame: change from baseline up to 6 months ]
  8. Score on Beck Depression Inventory II (BDI-II) [ Time Frame: change from baseline up to 6 months ]
    Higher score indicate a higher level of depression (range: 0-63).

  9. Score on Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM) [ Time Frame: change from baseline up to 6 months ]
    Assess the level of current psychological distress (range:0-136). Higher score indicate higher level of distress.

  10. Score on General Perceived Self-Efficacy Scale [ Time Frame: change from baseline up to 6 months ]
    Assess a general sense of perceived self-efficacy (range:10-40). Higher score indicate higher self-efficacy.

  11. Score on Return to Work Self-Efficacy Scale (RTW-SE) [ Time Frame: 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.

  12. Score on Difficulties in Emotion Regulation Scale (DERS) [ Time Frame: change from baseline up to 6 months ]
    Higher score indicate a higher level of difficulties in emotion regulation (range:36-180).

  13. Score on The Ruminative Response Scale (RRS) [ Time Frame: change from baseline up to 6 months ]
    Higher score indicate a higher level of ruminative responses (range: 22-88).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03338413


Contacts
Layout table for location contacts
Contact: Jan Stubberud, ph.d 95104217 jan.stubberud@hotmail.com
Contact: Bjørn Hagen, cand.psychol 91301061 BjornOleIngulfsvann.Hagen@lds.no

Locations
Layout table for location information
Norway
Lovisenberg Diaconal Hospital
Oslo, Norway
Sponsors and Collaborators
Lovisenberg Diakonale Hospital
University of Oslo
Yale University
Investigators
Layout table for investigator information
Study Director: Andreas Joner Lovisenberg Diaconal Hospital

Layout table for additonal information
Responsible Party: Lovisenberg Diakonale Hospital
ClinicalTrials.gov Identifier: NCT03338413     History of Changes
Other Study ID Numbers: 2017/666
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lovisenberg Diakonale Hospital:
Rehabilitation
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders