Major Depressive DisorderNCT04721678
Internet-administered Interpersonal Psychotherapy for Depressive Symptoms
A study testing Interpersonal psychotherapy in people with Major Depressive Disorder, run by Linkoeping University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Interpersonal psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteSweden
- Study dates
- 22 Jan 2021to 15 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Behavioral Sciences and Learning, Linköping University
Linköping, Östergötland County, 58183
About this study
Official title: INDIGO - 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.
- Conditions
- Major Depressive Disorder
- Being tested
- Interpersonal psychotherapy
- Keywords
- Interpersonal Psychotherapy, Major Depressive Disorder, Internet Intervention, Internet-based psychotherapy
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpersonal psychotherapyBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Interpersonal psychotherapy (IPT) | Experimental | 10 weeks of internet-administered interpersonal psychotherapy with therapist support. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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)
Measure of subjective quality of life. Sum scores can range between 0 and 96. Higher scores indicate a higher quality of life.
Measured: 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)
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.
Measured: 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)
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.
Measured: Before treatment, after 11 weeks, following one year after the start of the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start22 Jan 2021
- Primary completion15 Feb 2022
- Study completion15 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gerhard Andersson, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04721678
- Sponsor's protocol ID
- INDIGO
- Status last verified
- Dec 2023
- First submitted
- 8 Jan 2021
- Last updated
- 11 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39343313
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INDIGO - Internet-administered Interpersonal Psychotherapy for Depressive Symptoms
- ClinicalTrials.gov ID
- NCT04721678
- Acronym / sponsor ID
- INDIGO
- Conditions
- Major Depressive Disorder
- Keywords
- Interpersonal Psychotherapy, Major Depressive Disorder, Internet Intervention, Internet-based psychotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- 22 Jan 2021 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 25 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interpersonal psychotherapy (IPT) | Experimental | Behavioral: Interpersonal psychotherapy10 weeks of internet-administered interpersonal psychotherapy with therapist support. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interpersonal psychotherapyInternet-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). | Behavioural | Interpersonal psychotherapy (IPT) |
Primary outcome
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.
4 secondary outcomes
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Derived from this study: PubMed 39343313Kall 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interpersonal psychotherapy in people with Major Depressive Disorder, run by Linkoeping University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04721678, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023.