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Internet-administered Interpersonal Psychotherapy for Depressive Symptoms

INDIGO - Internet-administered Interpersonal Psychotherapy for Depressive Symptoms

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04721678
Enrollment
113
Registered
2021-01-25
Start date
2021-01-22
Completion date
2022-02-15
Last updated
2023-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Keywords

Interpersonal Psychotherapy, Major Depressive Disorder, Internet Intervention, Internet-based psychotherapy

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.

Interventions

BEHAVIORALInterpersonal 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).

Sponsors

Linkoeping University
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
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 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.
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.

Other

MeasureTime frameDescription
Score on Credibility and Expectancy Questionnaire (CEQ)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.
Score on Interpersonal Psychotherapy Outcome Scale (IPOS)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.
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.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.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026