Internet-administered Interpersonal Psychotherapy for Depressive Symptoms

Study Overview
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Brief Summary
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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.

Official Title
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INDIGO - Internet-administered Interpersonal Psychotherapy for Depressive Symptoms

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Behavioral: Interpersonal psychotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interpersonal psychotherapy (IPT)<br>10 weeks of internet-administered interpersonal psychotherapy with therapist support. | Behavioral: Interpersonal psychotherapy<br>* Internet-based interpersonal psychotherapy aimed at reducing symptoms of depression. The content of the intervention is divided into three parts: the assessment phase (the first four weeks), the focus phase (the following five weeks), and the end phase (the last week).<br>|
| No Intervention: Wait-list control group<br>The participants in the control group will receive access to the treatment after the post-treatment assessment has been conducted. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change on Montgomery Åsberg Depression Rating Scale (MADRS-S) | 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. | Before the treatment, during week 1 to 10 of the treatment, after 11 weeks. Follow-up one year after the start of the treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change on Beck Depression Inventory-II (BDI-II) | Depression inventory consisting of 21 items measuring symptoms of depressions along with behavioural and cognitive manifestations of these symptoms. Sum scores range between 0 and 63 points. Cut-offs: 0-13 minimal depressive symptoms, 14-19 mild depressive symptoms, 20-28 moderate depressive symptoms, 30-63 severe depressive symptoms. | Before treatment and after 11 weeks, follow-up one year after the start of the treatment. | 
| Change on Brunnsviken Brief Quality of Life Inventory (BBQ) | Measure of subjective quality of life. Sum scores can range between 0 and 96. Higher scores indicate a higher quality of life. | 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) | Seven item measure of generalized anxiety disorder. Sum score range from 0 to 21, with higher scores indicating more generalized anxiety. Cut-offs for interpretation: 0-5 minimal anxiety, 6-9 mild anxiety, 10-14 moderate anxiety, and 15-21 severe anxiety. | 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) | Instrument measuring reflective functioning related to mentalization ability. Eight items where the respondent answers on a Likert scale. The scoring is calculated based on two scales, uncertainty and certainty. All eight items are scored twice, once for each scale. The Likert options for the scoring of the first scale is scored 0 0 0 0 1 2 3. The same items are then summed again with the scoring 3 2 1 0 0 0 0. All items are the summed up to give a measure of mentalization certainty and uncertainty. | Before treatment, after 11 weeks, following one year after the start of the treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Interpersonal Psychotherapy, Major Depressive Disorder, Internet Intervention, Internet-based psychotherapy