Internet-administered Interpersonal Psychotherapy for Depressive Symptoms

December 8, 2023 updated by: Gerhard Andersson, Linkoeping University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
113

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change on Beck Depression Inventory-II (BDI-II)
Time Frame: Before treatment and after 11 weeks, follow-up one year after the start of the treatment.
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)
Time Frame: Before treatment and after 11 weeks, follow-up one year after the start of the treatment.
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)
Time Frame: Before treatment and after 11 weeks, follow-up one year after the start of the treatment.
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)
Time Frame: Before treatment, after 11 weeks, following one year after the start of the treatment.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change on The Medical Outcome Social Support Survey, 12-item short form (MOS-SSS)
Time Frame: Before the treatment, during week 1 to 10 of the treatment, after 11 weeks.
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)
Time Frame: Measured 11 weeks after the start of the intervention.
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)
Time Frame: Measured during week 3 of the intervention.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Linkoeping University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 22, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 8, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 25, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 11, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings