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Clinical Trials/NCT04721678
NCT04721678
Completed
Not Applicable

INDIGO - Internet-administered Interpersonal Psychotherapy for Depressive Symptoms

Linkoeping University1 site in 1 country113 target enrollmentJanuary 22, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Major Depressive Disorder
Sponsor
Linkoeping University
Enrollment
113
Locations
1
Primary Endpoint
Change on Montgomery Åsberg Depression Rating Scale (MADRS-S)
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The aim of the study is to test the efficacy of a treatment for depression based on interpersonal psychotherapy (IPT). The treatment will be accessed via an internet platform built for this study. A therapist will provide support weekly, as well as on-demand when needed. The treatment lasts for 10 weeks.

Registry
clinicaltrials.gov
Start Date
January 22, 2021
End Date
February 15, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Linkoeping University
Responsible Party
Principal Investigator
Principal Investigator

Gerhard Andersson

Professor

Linkoeping University

Eligibility Criteria

Inclusion Criteria

  • A diagnosis of Major depressive disorder (as indicated by the MINI 7.0 Neuropsychiatric interview) and/or depressive symptoms equal to or more severe than mild depression on the MADRS-S (equal to or above 13 points) and/or BDI (equal to or above 14 points).
  • Age of at least 18 years old.
  • Adequate ability to speak, write, and read Swedish.
  • Internet access for the duration of the study.

Exclusion Criteria

  • Ongoing substance abuse.
  • Suicidal plans.
  • A diagnosed personality syndrome (as diagnosed before the study by a licensed psychiatric healthcare professional).
  • Other ongoing psychological treatment.
  • Other severe psychiatric comorbidity that requires specialized care (e.g. anorexia nervosa, psychosis).
  • Recent changes in psychotropic medication or planned changes during the initial treatment period.

Outcomes

Primary Outcomes

Change on Montgomery Åsberg Depression Rating Scale (MADRS-S)

Time Frame: Before the treatment, during week 1 to 10 of the treatment, after 11 weeks. Follow-up one year after the start of the treatment.

Depression inventory, consists of 9 items measuring symptoms of major depressive disorder. Each item are scored between 0 and 6 points, resulting in a total sum between 0 and 54. Cut-offs are: 0-12 No substantial depressive symptoms, 13-19 mild depressive symptoms, 20-34 moderate depressive symptoms, 35-54 severe depressive symptoms.

Secondary Outcomes

  • Change on Brunnsviken Brief Quality of Life Inventory (BBQ)(Before treatment and after 11 weeks, follow-up one year after the start of the treatment.)
  • Change on Generalized Anxiety Disorder 7-Item Scale (GAD-7)(Before treatment and after 11 weeks, follow-up one year after the start of the treatment.)
  • Change on Reflective Functioning Questionnaire-8 item version (RFQ-8)(Before treatment, after 11 weeks, following one year after the start of the treatment.)
  • Change on Beck Depression Inventory-II (BDI-II)(Before treatment and after 11 weeks, follow-up one year after the start of the treatment.)

Study Sites (1)

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