DepressionNCT03338413
Cognitive Rehabilitation in Patients With Depression
A study testing Goal Management Training and Computerized Cognitive Training in people with Depression, run by Lovisenberg Diakonale Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Depression
- What is being tested?
- Goal Management Training and Computerized Cognitive Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2018to Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive Rehabilitation in Patients With Active and Remitted Depression - a Randomized Controlled Trial
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
- Being tested
- Goal Management Training, Computerized Cognitive Training
- Keywords
- Rehabilitation
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal Management TrainingBehavioural
9 GMT modules will be administered in 9X2 hour sessions (ten groups). Manualized intervention; metacognitive strategies for improving attention and problem solving.
Computerized Cognitive TrainingBehavioural
Also called Active control condition
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.
| Study group | Role | What they receive |
|---|---|---|
| Goal Management Training | Experimental | Not described Receives: Behavioral: Goal Management Training |
| Computerized Cognitive Training | Experimental | Not described Receives: Behavioral: Computerized Cognitive Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline up to 6 months
Secondary outcomes (13)
Performance on Conners Continuous Performance test III incl. CATA
Measured: change from baseline up to 6 months
Performance on Wisconsin Card Sorting Test
Measured: change from baseline up to 6 months
Performance on D-KEFS Color Word Interference Test
Measured: change from baseline up to 6 months
Performance on The Emotional Stroop
Measured: change from baseline up to 6 months
Performance on the Emo 1-back task
Measured: change from baseline up to 6 months
Score on Cognitive Failures Questionnaire (CFQ)
Assess frequency of cognitive failures (range:0-100). Higher Score indicate more frequent cognitive failures.
Measured: change from baseline up to 6 months
Score on Goal Attainment Scaling (GAS)
Measured: change from baseline up to 6 months
Score on Beck Depression Inventory II (BDI-II)
Higher score indicate a higher level of depression (range: 0-63).
Measured: change from baseline up to 6 months
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.
Measured: change from baseline up to 6 months
Score on General Perceived Self-Efficacy Scale
Assess a general sense of perceived self-efficacy (range:10-40). Higher score indicate higher self-efficacy.
Measured: change from baseline up to 6 months
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.
Measured: change from baseline up to 6 months
Score on Difficulties in Emotion Regulation Scale (DERS)
Higher score indicate a higher level of difficulties in emotion regulation (range:36-180).
Measured: change from baseline up to 6 months
Score on The Ruminative Response Scale (RRS)
Higher score indicate a higher level of ruminative responses (range: 22-88).
Measured: change from baseline up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study startJan 2018 (estimated)
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lovisenberg Diakonale Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, Yale University
- Responsible party
- Sponsor
- Investigators
- Andreas Joner, Study director, Lovisenberg Diaconal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03338413
- Sponsor's protocol ID
- 2017/666
- Status last verified
- Nov 2017
- First submitted
- 7 Nov 2017
- Last updated
- 14 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Rehabilitation in Patients With Active and Remitted Depression - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03338413
- Acronym / sponsor ID
- 2017/666
- Conditions
- Depression
- Keywords
- Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Lovisenberg Diakonale HospitalUniversity, hospital or other
- Collaborators
- University of Oslo, Yale University
- Study start
- Jan 2018 (estimated)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 9 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Goal Management Training | Experimental | Behavioral: Goal Management Training |
| Computerized Cognitive Training | Experimental | Behavioral: Computerized Cognitive Training |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Goal Management Training9 GMT modules will be administered in 9X2 hour sessions (ten groups). Manualized intervention; metacognitive strategies for improving attention and problem solving. | Behavioural | Goal Management Training |
| Computerized Cognitive TrainingAlso: Active control condition9 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. | Behavioural | Computerized Cognitive Training |
Primary outcome
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.
13 secondary outcomes
Performance on Conners Continuous Performance test III incl. CATA
Time frame: change from baseline up to 6 months
Performance on Wisconsin Card Sorting Test
Time frame: change from baseline up to 6 months
Performance on D-KEFS Color Word Interference Test
Time frame: change from baseline up to 6 months
Performance on The Emotional Stroop
Time frame: change from baseline up to 6 months
Performance on the Emo 1-back task
Time frame: change from baseline up to 6 months
Score on Cognitive Failures Questionnaire (CFQ)
Time frame: change from baseline up to 6 months
Score on Goal Attainment Scaling (GAS)
Time frame: change from baseline up to 6 months
Score on Beck Depression Inventory II (BDI-II)
Time frame: change from baseline up to 6 months
Score on Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM)
Time frame: change from baseline up to 6 months
Score on General Perceived Self-Efficacy Scale
Time frame: change from baseline up to 6 months
Score on Return to Work Self-Efficacy Scale (RTW-SE)
Time frame: change from baseline up to 6 months
Score on Difficulties in Emotion Regulation Scale (DERS)
Time frame: change from baseline up to 6 months
Score on The Ruminative Response Scale (RRS)
Time frame: change from baseline up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Joner study director
Lovisenberg Diaconal Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goal Management Training and Computerized Cognitive Training in people with Depression, run by Lovisenberg Diakonale Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan Stubberud, ph.d (95104217, jan.stubberud@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavior Rating Inventory of Executive Function (BRIEF: self and informant form) (time frame: Change from baseline up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2017.