Cognitive Rehabilitation in Patients With Depression

Sponsor
Lovisenberg Diakonale Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03338413
Collaborator
University of Oslo (Other), Yale University (Other)
100
1
2
29
3.5

Study Details

Study Description

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
  • Behavioral: Goal Management Training
  • Behavioral: Computerized Cognitive Training
N/A

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Jan 1, 2018
Anticipated Primary Completion Date :
Jun 1, 2020
Anticipated Study Completion Date :
Jun 1, 2020

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Performance on Conners Continuous Performance test III incl. CATA [change from baseline up to 6 months]

    2. Performance on Wisconsin Card Sorting Test [change from baseline up to 6 months]

    3. Performance on D-KEFS Color Word Interference Test [change from baseline up to 6 months]

    4. Performance on The Emotional Stroop [change from baseline up to 6 months]

    5. Performance on the Emo 1-back task [change from baseline up to 6 months]

    6. 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.

    7. Score on Goal Attainment Scaling (GAS) [change from baseline up to 6 months]

    8. 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).

    9. 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.

    10. 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.

    11. 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.

    12. 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).

    13. 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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Lovisenberg Diaconal Hospital Oslo Norway

    Sponsors and Collaborators

    • Lovisenberg Diakonale Hospital
    • University of Oslo
    • Yale University

    Investigators

    • Study Director: Andreas Joner, Lovisenberg Diaconal Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lovisenberg Diakonale Hospital
    ClinicalTrials.gov Identifier:
    NCT03338413
    Other Study ID Numbers:
    • 2017/666
    First Posted:
    Nov 9, 2017
    Last Update Posted:
    Nov 14, 2017
    Last Verified:
    Nov 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Lovisenberg Diakonale Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 14, 2017