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Cognitive Rehabilitation in Patients With Depression

Primary Purpose

Depression

Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Goal Management Training
Computerized Cognitive Training
Sponsored by
Lovisenberg Diakonale Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Rehabilitation

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Lovisenberg Diaconal Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Goal Management Training

Computerized Cognitive Training

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Performance on Conners Continuous Performance test III incl. CATA
Performance on Wisconsin Card Sorting Test
Performance on D-KEFS Color Word Interference Test
Performance on The Emotional Stroop
Performance on the Emo 1-back task
Score on Cognitive Failures Questionnaire (CFQ)
Assess frequency of cognitive failures (range:0-100). Higher Score indicate more frequent cognitive failures.
Score on Goal Attainment Scaling (GAS)
Score on Beck Depression Inventory II (BDI-II)
Higher score indicate a higher level of depression (range: 0-63).
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.
Score on General Perceived Self-Efficacy Scale
Assess a general sense of perceived self-efficacy (range:10-40). Higher score indicate higher self-efficacy.
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.
Score on Difficulties in Emotion Regulation Scale (DERS)
Higher score indicate a higher level of difficulties in emotion regulation (range:36-180).
Score on The Ruminative Response Scale (RRS)
Higher score indicate a higher level of ruminative responses (range: 22-88).

Full Information

First Posted
November 7, 2017
Last Updated
November 13, 2017
Sponsor
Lovisenberg Diakonale Hospital
Collaborators
University of Oslo, Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT03338413
Brief Title
Cognitive Rehabilitation in Patients With Depression
Official Title
Cognitive Rehabilitation in Patients With Active and Remitted Depression - a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2018 (Anticipated)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
June 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lovisenberg Diakonale Hospital
Collaborators
University of Oslo, Yale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Goal Management Training
Arm Type
Experimental
Arm Title
Computerized Cognitive Training
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Goal Management Training
Intervention Description
9 GMT modules will be administered in 9X2 hour sessions (ten groups). Manualized intervention; metacognitive strategies for improving attention and problem solving.
Intervention Type
Behavioral
Intervention Name(s)
Computerized Cognitive Training
Other Intervention Name(s)
Active control condition
Intervention Description
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.
Primary Outcome Measure Information:
Title
Behavior Rating Inventory of Executive Function (BRIEF: self and informant form)
Description
Executive function in daily life (range:70-210). Higher score indicate greater executive dysfunction.
Time Frame
Change from baseline up to 6 months
Secondary Outcome Measure Information:
Title
Performance on Conners Continuous Performance test III incl. CATA
Time Frame
change from baseline up to 6 months
Title
Performance on Wisconsin Card Sorting Test
Time Frame
change from baseline up to 6 months
Title
Performance on D-KEFS Color Word Interference Test
Time Frame
change from baseline up to 6 months
Title
Performance on The Emotional Stroop
Time Frame
change from baseline up to 6 months
Title
Performance on the Emo 1-back task
Time Frame
change from baseline up to 6 months
Title
Score on Cognitive Failures Questionnaire (CFQ)
Description
Assess frequency of cognitive failures (range:0-100). Higher Score indicate more frequent cognitive failures.
Time Frame
change from baseline up to 6 months
Title
Score on Goal Attainment Scaling (GAS)
Time Frame
change from baseline up to 6 months
Title
Score on Beck Depression Inventory II (BDI-II)
Description
Higher score indicate a higher level of depression (range: 0-63).
Time Frame
change from baseline up to 6 months
Title
Score on Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM)
Description
Assess the level of current psychological distress (range:0-136). Higher score indicate higher level of distress.
Time Frame
change from baseline up to 6 months
Title
Score on General Perceived Self-Efficacy Scale
Description
Assess a general sense of perceived self-efficacy (range:10-40). Higher score indicate higher self-efficacy.
Time Frame
change from baseline up to 6 months
Title
Score on Return to Work Self-Efficacy Scale (RTW-SE)
Description
Assess self-efficacy in the Return to work context (range:0-55). Higher score indicate higher self-efficacy.
Time Frame
change from baseline up to 6 months
Title
Score on Difficulties in Emotion Regulation Scale (DERS)
Description
Higher score indicate a higher level of difficulties in emotion regulation (range:36-180).
Time Frame
change from baseline up to 6 months
Title
Score on The Ruminative Response Scale (RRS)
Description
Higher score indicate a higher level of ruminative responses (range: 22-88).
Time Frame
change from baseline up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Stubberud, ph.d
Phone
95104217
Email
jan.stubberud@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Bjørn Hagen, cand.psychol
Phone
91301061
Email
BjornOleIngulfsvann.Hagen@lds.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Joner
Organizational Affiliation
Lovisenberg Diaconal Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Lovisenberg Diaconal Hospital
City
Oslo
Country
Norway

12. IPD Sharing Statement

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Cognitive Rehabilitation in Patients With Depression

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