Clinical trial NCT04721678: Internet-administered Interpersonal Psychotherapy for Depressive Symptoms
Official title: INDIGO - Internet-administered Interpersonal Psychotherapy for Depressive Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Interpersonal Psychotherapy
Major Depressive Disorder
Internet Intervention
Internet-based psychotherapy
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2021-01-25
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change on Montgomery Åsberg Depression Rating Scale (MADRS-S)
timeFrame: 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:
measure: Change on Beck Depression Inventory-II (BDI-II)
timeFrame: Before treatment and after 11 weeks, follow-up one year after the start of the treatment.
measure: Change on Brunnsviken Brief Quality of Life Inventory (BBQ)
timeFrame: Before treatment and after 11 weeks, follow-up one year after the start of the treatment.
measure: Change on Generalized Anxiety Disorder 7-Item Scale (GAD-7)
timeFrame: Before treatment and after 11 weeks, follow-up one year after the start of the treatment.
measure: Change on Reflective Functioning Questionnaire-8 item version (RFQ-8)
timeFrame: Before treatment, after 11 weeks, following one year after the start of the treatment.
Other outcomes:
measure: Change on The Medical Outcome Social Support Survey, 12-item short form (MOS-SSS)
timeFrame: Before the treatment, during week 1 to 10 of the treatment, after 11 weeks.
measure: Score on Interpersonal Psychotherapy Outcome Scale (IPOS)
timeFrame: Measured 11 weeks after the start of the intervention.
measure: Score on Credibility and Expectancy Questionnaire (CEQ)
timeFrame: Measured during week 3 of the intervention.
Locations:
city: Linköping
country: Sweden
facility: Department of Behavioral Sciences and Learning, Linköping University
state: Östergötland
Study officials:
References: