- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01532219
Internet-delivered Psychodynamic Therapy for Depression and Anxiety Disorders (ATLAS)
April 23, 2013 updated by: Gerhard Andersson, Linkoeping University
Internet-delivered Psychodynamic Therapy for Depression and Anxiety Disorders: A Randomized Controlled Trial
The overall aim of this study is to develop and test a psychodynamic Internet-delivered psychological treatment for patients with major depression and/or anxiety disorders and compare its efficacy to an active control group.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Linköping, Sweden, 58183
- Linköping University, Department of Behavioral Sciences and Learning
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Clinical diagnosis of Major Depressive Disorder, Panic Disorder, Social Anxiety Disorder, Generalized Anxiety disorder, Depressive Disorder NOS or Anxiety Disorder NOS
- 10 or higher on the PHQ-9 or on the GAD-7 at pre-treatment
Exclusion Criteria:
- Primary diagnosis of Obsessive Compulsive Disorder or Post-traumatic Stress Disorder
- Severe psychiatric condition (e.g. psychosis or bipolar disorder)
- Alcohol abuse (more than 16 on the AUDIT)
- Suicidal (measured in diagnostic interview)
- Changed medication during the last three months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Internet-delivered Psychodynamic Treatment
Participants in the experimental condition will receive 8 text-modules delivered as guided self-help, via the Internet.
The intervention lasts for 10 weeks and includes weekly contacts with a therapist via a secure online environment similar to e-mail.
The treatment is a short-term psychodynamic treatment psychodynamic treatment.
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Ten weeks of guided self-help + therapist contact, via the Internet.
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Active Comparator: Internet-delivered structured support
Participants in the active control condition will receive a structured support treatment via the Internet.
The intervention lasts for 10 weeks and includes weekly contacts with a therapist via a secure online environment similar to e-mail.
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Ten weeks of therapist contact, via the Internet.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
9-item Patient Health Questionnaire Depression Scale (PHQ-9)
Time Frame: Two weeks before the treatment starts
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Two weeks before the treatment starts
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7-item Patient Health Questionnaire Generalized Anxiety Disorder Scale (GAD-7)
Time Frame: Two weeks before the treatment starts
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Two weeks before the treatment starts
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9-item Patient Health Questionnaire Depression Scale (PHQ-9)
Time Frame: At treatment start (0 weeks)
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At treatment start (0 weeks)
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7-item Patient Health Questionnaire Generalized Anxiety Disorder Scale (GAD-7)
Time Frame: At treatment start (0 weeks)
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At treatment start (0 weeks)
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9-item Patient Health Questionnaire Depression Scale (PHQ-9)
Time Frame: At treatment termination (10 weeks)
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At treatment termination (10 weeks)
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7-item Patient Health Questionnaire Generalized Anxiety Disorder Scale (GAD-7)
Time Frame: At treatment termination (10 weeks)
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At treatment termination (10 weeks)
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9-item Patient Health Questionnaire Depression Scale (PHQ-9)
Time Frame: At treatment follow-up (7 months)
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At treatment follow-up (7 months)
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7-item Patient Health Questionnaire Generalized Anxiety Disorder Scale (GAD-7)
Time Frame: At treatment follow-up (7 months)
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At treatment follow-up (7 months)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Emotional Processing Scale (EPS-25)
Time Frame: Two weeks before the treatment starts
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Two weeks before the treatment starts
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Emotional Processing Scale (EPS-25)
Time Frame: At treatment start (0 weeks)
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At treatment start (0 weeks)
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Emotional Processing Scale (EPS-25)
Time Frame: At treatment termination (10 weeks)
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At treatment termination (10 weeks)
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Five Facets of Mindfulness Questionnaire (FFMQ)
Time Frame: Two weeks before the treatment starts
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Two weeks before the treatment starts
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Five Facets of Mindfulness Questionnaire (FFMQ)
Time Frame: At treatment start (0 weeks)
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At treatment start (0 weeks)
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Five Facets of Mindfulness Questionnaire (FFMQ)
Time Frame: At treatment termination (10 weeks)
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At treatment termination (10 weeks)
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Emotional Processing Scale (EPS-25)
Time Frame: At treatment follow-up (7 months)
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At treatment follow-up (7 months)
|
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Five Facets of Mindfulness Questionnaire (FFMQ)
Time Frame: At treatment follow-up (7 months)
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At treatment follow-up (7 months)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2012
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
February 9, 2012
First Submitted That Met QC Criteria
February 9, 2012
First Posted (Estimate)
February 14, 2012
Study Record Updates
Last Update Posted (Estimate)
April 24, 2013
Last Update Submitted That Met QC Criteria
April 23, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GA-DEPANX2012-APT
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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