Skip to main content
OpenTrials
Completed

NCT Number: NCT04721678

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Behavioral Sciences and Learning, Linköping University

Linköping, Östergötland County, 58183, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

interpersonal psychotherapy

Behavioral

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).

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Registry information

Official study title

INDIGO - Internet-administered Interpersonal Psychotherapy for Depressive Symptoms

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 25, 2021
Registry last updated
Dec 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.