Internet-delivered Psychodynamic Therapy for Depression and Anxiety Disorders (ATLAS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gerhard Andersson, Linkoeping University
ClinicalTrials.gov Identifier:
NCT01532219
First received: February 9, 2012
Last updated: April 23, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Depression
Anxiety
Behavioral: Internet-delivered Psychodynamic Treatment
Behavioral: Internet-delivered structured support

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Internet-delivered Psychodynamic Therapy for Depression and Anxiety Disorders: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Linkoeping University:

Primary Outcome Measures:
  • 9-item Patient Health Questionnaire Depression Scale (PHQ-9) [ Time Frame: Two weeks before the treatment starts ] [ Designated as safety issue: No ]
  • 7-item Patient Health Questionnaire Generalized Anxiety Disorder Scale (GAD-7) [ Time Frame: Two weeks before the treatment starts ] [ Designated as safety issue: No ]
  • 9-item Patient Health Questionnaire Depression Scale (PHQ-9) [ Time Frame: At treatment start (0 weeks) ] [ Designated as safety issue: No ]
  • 7-item Patient Health Questionnaire Generalized Anxiety Disorder Scale (GAD-7) [ Time Frame: At treatment start (0 weeks) ] [ Designated as safety issue: No ]
  • 9-item Patient Health Questionnaire Depression Scale (PHQ-9) [ Time Frame: At treatment termination (10 weeks) ] [ Designated as safety issue: No ]
  • 7-item Patient Health Questionnaire Generalized Anxiety Disorder Scale (GAD-7) [ Time Frame: At treatment termination (10 weeks) ] [ Designated as safety issue: No ]
  • 9-item Patient Health Questionnaire Depression Scale (PHQ-9) [ Time Frame: At treatment follow-up (7 months) ] [ Designated as safety issue: No ]
  • 7-item Patient Health Questionnaire Generalized Anxiety Disorder Scale (GAD-7) [ Time Frame: At treatment follow-up (7 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Emotional Processing Scale (EPS-25) [ Time Frame: Two weeks before the treatment starts ] [ Designated as safety issue: No ]
  • Emotional Processing Scale (EPS-25) [ Time Frame: At treatment start (0 weeks) ] [ Designated as safety issue: No ]
  • Emotional Processing Scale (EPS-25) [ Time Frame: At treatment termination (10 weeks) ] [ Designated as safety issue: No ]
  • Five Facets of Mindfulness Questionnaire (FFMQ) [ Time Frame: Two weeks before the treatment starts ] [ Designated as safety issue: No ]
  • Five Facets of Mindfulness Questionnaire (FFMQ) [ Time Frame: At treatment start (0 weeks) ] [ Designated as safety issue: No ]
  • Five Facets of Mindfulness Questionnaire (FFMQ) [ Time Frame: At treatment termination (10 weeks) ] [ Designated as safety issue: No ]
  • Emotional Processing Scale (EPS-25) [ Time Frame: At treatment follow-up (7 months) ] [ Designated as safety issue: No ]
  • Five Facets of Mindfulness Questionnaire (FFMQ) [ Time Frame: At treatment follow-up (7 months) ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: February 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: Internet-delivered Psychodynamic Treatment
Ten weeks of guided self-help + therapist contact, via the Internet.
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.
Behavioral: Internet-delivered structured support
Ten weeks of therapist contact, via the Internet.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01532219

Locations
Sweden
Linköping University, Department of Behavioral Sciences and Learning
Linköping, Sweden, 58183
Sponsors and Collaborators
Linkoeping University
  More Information

No publications provided

Responsible Party: Gerhard Andersson, Professor of Clinical Psychology, Linkoeping University
ClinicalTrials.gov Identifier: NCT01532219     History of Changes
Other Study ID Numbers: GA-DEPANX2012-APT
Study First Received: February 9, 2012
Last Updated: April 23, 2013
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
Mental Disorders
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on July 22, 2014