NCT04721678

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for not_applicable major-depressive-disorder

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2021

Completed
14 days until next milestone

Study Start

First participant enrolled

January 22, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 25, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2022

Completed
Last Updated

December 11, 2023

Status Verified

December 1, 2023

Enrollment Period

1.1 years

First QC Date

January 8, 2021

Last Update Submit

December 8, 2023

Conditions

Keywords

Interpersonal PsychotherapyMajor Depressive DisorderInternet InterventionInternet-based psychotherapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change on Beck Depression Inventory-II (BDI-II)

    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)

    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.

Other Outcomes (3)

  • Change on The Medical Outcome Social Support Survey, 12-item short form (MOS-SSS)

    Before the treatment, during week 1 to 10 of the treatment, after 11 weeks.

  • Score on Interpersonal Psychotherapy Outcome Scale (IPOS)

    Measured 11 weeks after the start of the intervention.

  • Score on Credibility and Expectancy Questionnaire (CEQ)

    Measured during week 3 of the intervention.

Study Arms (2)

Interpersonal psychotherapy (IPT)

EXPERIMENTAL

10 weeks of internet-administered interpersonal psychotherapy with therapist support.

Behavioral: Interpersonal psychotherapy

Wait-list control group

NO INTERVENTION

The participants in the control group will receive access to the treatment after the post-treatment assessment has been conducted.

Interventions

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).

Interpersonal psychotherapy (IPT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Behavioral Sciences and Learning, Linköping University

Linköping, Östergötland County, 58183, Sweden

Location

Related Publications (1)

  • Kall A, Back M, Fahlroth O, Ekeflod E, Lundberg A, Viberg N, Andersson G. Internet-based therapist-supported interpersonal psychotherapy for depression: A randomized controlled trial. J Affect Disord. 2025 Jan 15;369:188-194. doi: 10.1016/j.jad.2024.09.171. Epub 2024 Sep 27.

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Interpersonal Psychotherapy

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 8, 2021

First Posted

January 25, 2021

Study Start

January 22, 2021

Primary Completion

February 15, 2022

Study Completion

February 15, 2022

Last Updated

December 11, 2023

Record last verified: 2023-12

Locations