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Tackling Depression and Anxiety: A Working Memory Intervention

Primary Purpose

Major Depression, Anxiety Disorder

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Working memory training
Placebo training
Sponsored by
Erasmus Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depression focused on measuring Depression, Anxiety, Working memory, Rumination, Cognitive training, Executive functioning

Eligibility Criteria

16 Years - 68 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Major depression diagnosis
  • Anxiety disorder diagnosis

Exclusion Criteria:

  • Current psychosis
  • Current substance dependency

Sites / Locations

  • Erasmus University Rotterdam

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Working memory training

Placebo training

Arm Description

Outcomes

Primary Outcome Measures

Beck Depression Inventory Second Edition (BDI-II) score change between pre and post training and at follow-up measurement (2 months after post measurement)
Depression is measured with the BDI-II

Secondary Outcome Measures

State-Trait Anxiety Inventory (STAI) scores change from pre to post training and to follow up measurement (2 months after post measurement)
The STAI measures state, trait and total anxiety

Full Information

First Posted
April 8, 2014
Last Updated
April 18, 2014
Sponsor
Erasmus Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02119923
Brief Title
Tackling Depression and Anxiety: A Working Memory Intervention
Official Title
Effects of Working Memory Training in a Depressed and Anxious Sample
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Anxiety and depression are both associated with impairments in executive functions, including working memory (WM) which is needed to maintain and manipulate goal-relevant information. Due to these WM impairments anxious and depressed individuals have difficulties inhibiting and shifting from irrelevant (negative) information and updating goal relevant information. This study explored whether training WM decreases these impairments and reduces clinical symptoms and rumination. Eighty-four individuals diagnosed with major depression and forty-nine individuals with an anxiety diagnosis executed WM or control tasks three times a week, during four weeks. Before, after training and at a two months follow-up measurement depression and anxiety symptoms, WM capacity and rumination behaviour were assessed. Training WM did only result in a reduction of anxiety symptoms in the depression group. These findings are inconsistent with promising results of individual studies showing training WM result in an enlarged WM capacity and a decrease of psychopathological symptoms. However, our results are in line with recent meta-analyses and reviews which show that WM training do not lead to generalized effects and therefore, doubt the clinical relevance of WM training programs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression, Anxiety Disorder
Keywords
Depression, Anxiety, Working memory, Rumination, Cognitive training, Executive functioning

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Working memory training
Arm Type
Experimental
Arm Title
Placebo training
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
Working memory training
Intervention Description
The WM consisted of two tasks; the Number-letter task (Rogers & Monsell, 1995) and an Updating task. The Number-letter task trains the ability to shift between task relevant stimuli. Participants need to shift between four categories. In the Updating task participants receive a set of three words in which they have to compare the two consecutive words on emotional valence (positive or negative) to train their updating skills. Participants executed the training three times a week during four weeks.
Intervention Type
Behavioral
Intervention Name(s)
Placebo training
Intervention Description
Both the WM and the placebo training consisted of two tasks; the Number-letter task (Rogers & Monsell, 1995) and an Updating task. To prevent training WM the placebo training was a simplified version of the Number-letter task in which shifting was not required. In the Updating task the placebo group only had to count the number of positive or negative words. Participants executed the training three times a week during four weeks.
Primary Outcome Measure Information:
Title
Beck Depression Inventory Second Edition (BDI-II) score change between pre and post training and at follow-up measurement (2 months after post measurement)
Description
Depression is measured with the BDI-II
Time Frame
Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
Secondary Outcome Measure Information:
Title
State-Trait Anxiety Inventory (STAI) scores change from pre to post training and to follow up measurement (2 months after post measurement)
Description
The STAI measures state, trait and total anxiety
Time Frame
Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
Other Pre-specified Outcome Measures:
Title
Ruminative Response Scale (RRS) score change between pre and post training and follow up (two months after post)
Description
The RRS measures rumination
Time Frame
Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
Title
Symmetry Span score change between pre and post training and at follow-up measurement (2 months after post measurement)
Description
The Symmetry Span measures working memory capacity
Time Frame
Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
Title
Internal shift task score change between pre and post training and at follow-up measurement (2 months after post measurement)
Description
The internal shift task measures working memory capacity
Time Frame
Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Major depression diagnosis Anxiety disorder diagnosis Exclusion Criteria: Current psychosis Current substance dependency
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elke Geraerts, PhD
Organizational Affiliation
Erasmus University Rotterdam
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sabine Wanmaker, MSc
Organizational Affiliation
Erasmus University Rotterdam
Official's Role
Study Director
Facility Information:
Facility Name
Erasmus University Rotterdam
City
Rotterdam
State/Province
Zuid Holland
ZIP/Postal Code
3000 DR
Country
Netherlands

12. IPD Sharing Statement

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Tackling Depression and Anxiety: A Working Memory Intervention

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