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Trial record 2 of 7 for:    interpersonal | Depression | Sweden | Adult

Internet-administered Interpersonal Psychotherapy for Depressive Symptoms

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ClinicalTrials.gov Identifier: NCT04721678
Recruitment Status : Active, not recruiting
First Posted : January 25, 2021
Last Update Posted : February 11, 2021
Sponsor:
Information provided by (Responsible Party):
Gerhard Andersson, 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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Behavioral: Interpersonal psychotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: INDIGO - Internet-administered Interpersonal Psychotherapy for Depressive Symptoms
Actual Study Start Date : January 22, 2021
Estimated Primary Completion Date : February 15, 2022
Estimated Study Completion Date : February 15, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Interpersonal psychotherapy (IPT)
10 weeks of internet-administered interpersonal psychotherapy with therapist support.
Behavioral: Interpersonal 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).

No Intervention: Wait-list control group
The participants in the control group will receive access to the treatment after the post-treatment assessment has been conducted.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. ]
    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.

  2. 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. ]
    Measure of subjective quality of life. Sum scores can range between 0 and 96. Higher scores indicate a higher quality of life.

  3. 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. ]
    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.

  4. 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. ]
    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 Outcome Measures:
  1. Change on The Medical Outcome Social Support Survey, 12-item short form (MOS-SSS) [ Time Frame: 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.

  2. Score on Interpersonal Psychotherapy Outcome Scale (IPOS) [ Time Frame: 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.

  3. Score on Credibility and Expectancy Questionnaire (CEQ) [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04721678


Locations
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Sweden
Department of Behavioral Sciences and Learning, Linköping University
Linköping, Östergötland, Sweden, 58183
Sponsors and Collaborators
Linkoeping University
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Responsible Party: Gerhard Andersson, Professor, Linkoeping University
ClinicalTrials.gov Identifier: NCT04721678    
Other Study ID Numbers: INDIGO
First Posted: January 25, 2021    Key Record Dates
Last Update Posted: February 11, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gerhard Andersson, Linkoeping University:
Interpersonal Psychotherapy
Major Depressive Disorder
Internet Intervention
Internet-based psychotherapy
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms