Internet-administered Interpersonal Psychotherapy for Depressive Symptoms

Not Applicable

Completed

• Conditions: Major Depressive Disorder
• Interventions: Behavioral: Interpersonal psychotherapy

• Registration Number: NCT04721678
• Lead Sponsor: Linkoeping University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-08
• Study First Submitted QC: 2021-01-21
• Study Start: 2021-01-22
• Study First Posted: 2021-01-25
• Primary Completion: 2022-02-15
• Study Completion: 2022-02-15
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-08
• Last Update Posted: 2023-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interpersonal psychotherapy (IPT)	Interpersonal psychotherapy	10 weeks of internet-administered interpersonal psychotherapy with therapist support.

Primary Outcome Measures

Name	Time	Method
Change on Montgomery Åsberg Depression Rating Scale (MADRS-S)	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 Outcome Measures

Name	Time	Method
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.	Measure of subjective quality of life. Sum scores can range between 0 and 96. Higher scores indicate a higher quality of life.
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.	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.
Change on Reflective Functioning Questionnaire-8 item version (RFQ-8)	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.
Change on Beck Depression Inventory-II (BDI-II)	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.

Trial Locations

Locations (1)

Department of Behavioral Sciences and Learning, Linköping University; 🇸🇪 Linköping, Östergötland, Sweden