Back to resultsInternet-delivered Psychodynamic Therapy for Depression and Anxiety Disorders (ATLAS)
Primary Purpose
Depression, Anxiety
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Internet-delivered Psychodynamic Treatment
Internet-delivered structured support
Sponsored by
About this trial
This is an interventional treatment trial for Depression
Eligibility Criteria
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
Sites / Locations
- Linköping University, Department of Behavioral Sciences and Learning
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Internet-delivered Psychodynamic Treatment
Internet-delivered structured support
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
9-item Patient Health Questionnaire Depression Scale (PHQ-9)
7-item Patient Health Questionnaire Generalized Anxiety Disorder Scale (GAD-7)
9-item Patient Health Questionnaire Depression Scale (PHQ-9)
7-item Patient Health Questionnaire Generalized Anxiety Disorder Scale (GAD-7)
9-item Patient Health Questionnaire Depression Scale (PHQ-9)
7-item Patient Health Questionnaire Generalized Anxiety Disorder Scale (GAD-7)
9-item Patient Health Questionnaire Depression Scale (PHQ-9)
7-item Patient Health Questionnaire Generalized Anxiety Disorder Scale (GAD-7)
Secondary Outcome Measures
Emotional Processing Scale (EPS-25)
Emotional Processing Scale (EPS-25)
Emotional Processing Scale (EPS-25)
Five Facets of Mindfulness Questionnaire (FFMQ)
Five Facets of Mindfulness Questionnaire (FFMQ)
Five Facets of Mindfulness Questionnaire (FFMQ)
Emotional Processing Scale (EPS-25)
Five Facets of Mindfulness Questionnaire (FFMQ)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01532219
Brief Title
Internet-delivered Psychodynamic Therapy for Depression and Anxiety Disorders
Acronym
ATLAS
Official Title
Internet-delivered Psychodynamic Therapy for Depression and Anxiety Disorders: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Linkoeping University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Internet-delivered Psychodynamic Treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Internet-delivered structured support
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Internet-delivered Psychodynamic Treatment
Intervention Description
Ten weeks of guided self-help + therapist contact, via the Internet.
Intervention Type
Behavioral
Intervention Name(s)
Internet-delivered structured support
Intervention Description
Ten weeks of therapist contact, via the Internet.
Primary Outcome Measure Information:
Title
9-item Patient Health Questionnaire Depression Scale (PHQ-9)
Time Frame
Two weeks before the treatment starts
Title
7-item Patient Health Questionnaire Generalized Anxiety Disorder Scale (GAD-7)
Time Frame
Two weeks before the treatment starts
Title
9-item Patient Health Questionnaire Depression Scale (PHQ-9)
Time Frame
At treatment start (0 weeks)
Title
7-item Patient Health Questionnaire Generalized Anxiety Disorder Scale (GAD-7)
Time Frame
At treatment start (0 weeks)
Title
9-item Patient Health Questionnaire Depression Scale (PHQ-9)
Time Frame
At treatment termination (10 weeks)
Title
7-item Patient Health Questionnaire Generalized Anxiety Disorder Scale (GAD-7)
Time Frame
At treatment termination (10 weeks)
Title
9-item Patient Health Questionnaire Depression Scale (PHQ-9)
Time Frame
At treatment follow-up (7 months)
Title
7-item Patient Health Questionnaire Generalized Anxiety Disorder Scale (GAD-7)
Time Frame
At treatment follow-up (7 months)
Secondary Outcome Measure Information:
Title
Emotional Processing Scale (EPS-25)
Time Frame
Two weeks before the treatment starts
Title
Emotional Processing Scale (EPS-25)
Time Frame
At treatment start (0 weeks)
Title
Emotional Processing Scale (EPS-25)
Time Frame
At treatment termination (10 weeks)
Title
Five Facets of Mindfulness Questionnaire (FFMQ)
Time Frame
Two weeks before the treatment starts
Title
Five Facets of Mindfulness Questionnaire (FFMQ)
Time Frame
At treatment start (0 weeks)
Title
Five Facets of Mindfulness Questionnaire (FFMQ)
Time Frame
At treatment termination (10 weeks)
Title
Emotional Processing Scale (EPS-25)
Time Frame
At treatment follow-up (7 months)
Title
Five Facets of Mindfulness Questionnaire (FFMQ)
Time Frame
At treatment follow-up (7 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Linköping University, Department of Behavioral Sciences and Learning
City
Linköping
ZIP/Postal Code
58183
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Internet-delivered Psychodynamic Therapy for Depression and Anxiety Disorders
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