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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01324050
Other study ID # GA-DEP2011-PDT
Secondary ID
Status Completed
Phase N/A
First received March 25, 2011
Last updated August 1, 2011
Start date February 2011
Est. completion date May 2011

Study information

Verified date January 2011
Source Linkoeping University
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Interventional

Clinical Trial Summary

The overall aim of this study is to develop and test a psychodynamic Internet-delivered psychological treatment for patients with mild to moderate major depression and compare its efficacy to an active control group.


Recruitment information / eligibility

Status Completed
Enrollment 92
Est. completion date May 2011
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Clinical diagnosis of Major Depressive Disorder

- 15 or more on MADRS-S

Exclusion Criteria:

- Severe depression (more than 35 on MADRS-S or based on interview)

- Severe psychiatric condition (e.g. psychosis or bipolar disorder)

- Suicidal (measured in diagnostic interview)

- Changed medication during the last three months

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Internet-delivered psychodynamic therapy for depression
This intervention contains 9 text-based self-help modules. These modules contain material inspired by psychoanalytic theory about identifying reoccurring patterns in life among other things. In addition to the self-help modules, 10-15 minutes of therapist contact is given every week. In total, the intervention will last for 10 weeks.
Internet-delivered therapist support
This intervention contains 1 text-based self-help module, which is mainly based on information on depression. In addition to this text, the participants in this group gets 10-15 minutes of therapist contact every week. In the conversation with the therapist, the participant informs the therapist about the activities during the week. This intervention is considered to be a form of support. In total, the intervention will last for 10 weeks.

Locations

Country Name City State
Sweden Linköping University Linköping
Sweden Linköping University, Department of Behavioral Sciences and Learning Linköping

Sponsors (1)

Lead Sponsor Collaborator
Linkoeping University

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Beck Depression Inventory (BDI) Two weeks before the treatment starts
Primary Beck Depression Inventory (BDI) At treatment start (0 weeks)
Primary Beck Depression Inventory (BDI) At treatment termination (10 weeks)
Secondary Beck Anxiety Inventory (BAI) Two weeks before the treatment starts
Secondary Beck Anxiety Inventory (BAI) At treatment termination (10 weeks)
Secondary Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S) Two weeks before treatment starts
Secondary Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S) At treatment termination (10 weeks)
Secondary Quality of Life Inventory (QOLI) Two weeks before treatment starts
Secondary Quality of Life Inventory (QOLI) At treatment termination (10 weeks)
Secondary Patient Health Questionnaire 9 (PHQ-9) Two weeks before treatment starts
Secondary Patient Health Questionnaire 9 (PHQ-9) At treatment termination (10 weeks)
Secondary Generalised Anxiety Disorder Assessment 7 (GAD-7) Two weeks before treatment starts
Secondary Generalised Anxiety Disorder Assessment 7 (GAD-7) At treatment termination (10 weeks)
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