Internet-administered Interpersonal Psychotherapy for Depressive Symptoms

INDIGO - Internet-administered Interpersonal Psychotherapy for Depressive Symptoms

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Behavioral: Interpersonal psychotherapy

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Östergötland
    • Linköping, Östergötland, Sweden, 58183
      • Department of Behavioral Sciences and Learning, Linköping University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interpersonal psychotherapy (IPT); 10 weeks of internet-administered interpersonal psychotherapy with therapist support.	Behavioral: Interpersonal psychotherapy; 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).
No Intervention: Wait-list control group; 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?

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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change on The Medical Outcome Social Support Survey, 12-item short form (MOS-SSS)	Mediational measure of perceived social support. Consists of six items summed up to a score between 12 and 60. Higher scores indicate more perceived social support.	Before the treatment, during week 1 to 10 of the treatment, after 11 weeks.
Score on Interpersonal Psychotherapy Outcome Scale (IPOS)	Questionnaire asking the participant to identify the focus of the treatment and the perceived change in each focus area. Change is measured on a five-point Likert scale ranging from worsened significantly to improved greatly.	Measured 11 weeks after the start of the intervention.
Score on Credibility and Expectancy Questionnaire (CEQ)	Measure of the credible the participant perceive the intervention to be as well as how beneficial they expect it to be. Consists of six items, with four of them being answered on a nine-point Likert scale and two responses given on a ten-point Likert scale. Scores can range between 4 and 56, with higher scores indicating greater credibility and expectancy of positive change during the intervention.	Measured during week 3 of the intervention.

Collaborators and Investigators

• Sponsor: Linkoeping University

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2021
• Primary Completion (Actual): February 15, 2022
• Study Completion (Actual): February 15, 2022

Study Registration Dates

• First Submitted: January 8, 2021
• First Submitted That Met QC Criteria: January 21, 2021
• First Posted (Actual): January 25, 2021

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Internet Intervention; Major Depressive Disorder; Interpersonal Psychotherapy; Internet-based psychotherapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: INDIGO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No