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Internet-administered Interpersonal Psychotherapy for Depressive Symptoms

Primary Purpose

Major Depressive Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Interpersonal psychotherapy
Sponsored by
Linkoeping University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Interpersonal Psychotherapy, Major Depressive Disorder, Internet Intervention, Internet-based psychotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Behavioral Sciences and Learning, Linköping University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Interpersonal psychotherapy (IPT)

Wait-list control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
January 8, 2021
Last Updated
February 10, 2021
Sponsor
Linkoeping University
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1. Study Identification

Unique Protocol Identification Number
NCT04721678
Brief Title
Internet-administered Interpersonal Psychotherapy for Depressive Symptoms
Official Title
INDIGO - Internet-administered Interpersonal Psychotherapy for Depressive Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 22, 2021 (Actual)
Primary Completion Date
February 15, 2022 (Anticipated)
Study Completion Date
February 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Linkoeping University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Interpersonal Psychotherapy, Major Depressive Disorder, Internet Intervention, Internet-based psychotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
113 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interpersonal psychotherapy (IPT)
Arm Type
Experimental
Arm Description
10 weeks of internet-administered interpersonal psychotherapy with therapist support.
Arm Title
Wait-list control group
Arm Type
No Intervention
Arm Description
The participants in the control group will receive access to the treatment after the post-treatment assessment has been conducted.
Intervention Type
Behavioral
Intervention Name(s)
Interpersonal psychotherapy
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change on Montgomery Åsberg Depression Rating Scale (MADRS-S)
Description
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.
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.
Secondary Outcome Measure Information:
Title
Change on Beck Depression Inventory-II (BDI-II)
Description
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.
Time Frame
Before treatment and after 11 weeks, follow-up one year after the start of the treatment.
Title
Change on Brunnsviken Brief Quality of Life Inventory (BBQ)
Description
Measure of subjective quality of life. Sum scores can range between 0 and 96. Higher scores indicate a higher quality of life.
Time Frame
Before treatment and after 11 weeks, follow-up one year after the start of the treatment.
Title
Change on Generalized Anxiety Disorder 7-Item Scale (GAD-7)
Description
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.
Time Frame
Before treatment and after 11 weeks, follow-up one year after the start of the treatment.
Title
Change on Reflective Functioning Questionnaire-8 item version (RFQ-8)
Description
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.
Time Frame
Before treatment, after 11 weeks, following one year after the start of the treatment.
Other Pre-specified Outcome Measures:
Title
Change on The Medical Outcome Social Support Survey, 12-item short form (MOS-SSS)
Description
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.
Time Frame
Before the treatment, during week 1 to 10 of the treatment, after 11 weeks.
Title
Score on Interpersonal Psychotherapy Outcome Scale (IPOS)
Description
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.
Time Frame
Measured 11 weeks after the start of the intervention.
Title
Score on Credibility and Expectancy Questionnaire (CEQ)
Description
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.
Time Frame
Measured during week 3 of the intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Department of Behavioral Sciences and Learning, Linköping University
City
Linköping
State/Province
Östergötland
ZIP/Postal Code
58183
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Internet-administered Interpersonal Psychotherapy for Depressive Symptoms

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