Depression Clinical Trial
Official title:
Internet-delivered Psychodynamic Therapy for Depression: a Randomized Controlled Trial
| Verified date | January 2011 |
| Source | Linkoeping University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Sweden: Regional Ethical Review Board |
| Study type | Interventional |
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.
| 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Linköping University | Linköping | |
| Sweden | Linköping University, Department of Behavioral Sciences and Learning | Linköping |
| Lead Sponsor | Collaborator |
|---|---|
| Linkoeping University |
Sweden,
| 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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