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ICBT for Depression - A Factorial Investigation of Kinds of Therapist Support and Self-/Expert-selected Content

Primary Purpose

Depressive Disorder, Major, Depressive Symptoms

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Internet-administered Cognitive behavioral therapy (ICBT)
Sponsored by
Linkoeping University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder, Major

Eligibility Criteria

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

Inclusion Criteria:

  • Current depressive symptoms equivalent to a score of at least 5 on Patient Health Questionnaire 9 and a minimum of 10 points on Becks Depression Inventory.
  • 18 years or older.
  • Adequate ability to understand and speak Swedish.
  • Access to the internet and a smartphone/computer.

Exclusion Criteria:

  • Other ongoing psychological treatment or counselling.
  • Recent (within the past 3 months) changes in the dose of psychotropic medication.
  • Prior diagnosis of psychosis, bipolar disorder, or substance dependence.

Sites / Locations

  • Linköping University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Expert-chosen content, regular guidance

Expert-chosen content, on-demand guidance

Participant-chosen content, regular guidance

Participant-chosen content, on-demand guidance

Arm Description

Content chosen by the therapist, weekly guidance by a therapist.

Content chosen by the therapist, guidance upon request from the health care team.

Content chosen by participants themselves, weekly guidance by a therapist.

Content chosen by participants themselves, guidance upon request from the health care team.

Outcomes

Primary Outcome Measures

Change on Becks Depression Inventory-II (BDI-II)
Measure of depressive symptoms. Possible range for the total sum: 0 to 63 (created by summing up the score from each item). Clinical ranges for minimal, mild, moderate and severe major depressive disorder are considered to be 0-13, 13-19, 20-28, and 29-63 points.
Change on Patient Health Questionnaire (PHQ-9)
Measure of depressive symptoms. Possible range for the total sum: 0 to 27 (created by summing up the score from each item). Clinical cut-offs for mild, moderate, moderately severe and severe major depressive disorder are considered to be 5, 10, 15, and 20 points.

Secondary Outcome Measures

Change on Generalised Anxiety Disorder 7-item scale (GAD-7)
Measure of symptoms of generalised anxiety disorder (GAD). Seven items, the score is interpreted by summing up the score from each individual item. Higher scores indicate more severe problems with worry and generalised anxiety. The total sum ranges from 0 to 21 with cut-offs of 5, 10, and 15 representing mild, moderate and severe generalised anxiety.
Change on Brunnsviken Brief Quality of Life Scale (BBQ)
Measure of quality of life, total score ranging from 0 to 96 with a higher score indicating a higher quality of life. The scores of each of the six primary questions regarding perceived quality of life within an area of life are multiplied with the score of an item measuring the perceived importance of the area in question.
Change on Insomnia Severity Index (ISI)
Measure of insomnia severity and symptoms of disordered sleep. The total score can range between 0 (no sleep problems) to 28 (severe sleep problems and insomnia). Norm score ranges include low likelihood of sleep problems (0 to 7 points), some sleep problems (8 to 14 points), moderate sleep problems (15 to 21 points), severe sleep problems (22 to 28 points).

Full Information

First Posted
January 30, 2020
Last Updated
April 16, 2021
Sponsor
Linkoeping University
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1. Study Identification

Unique Protocol Identification Number
NCT04260750
Brief Title
ICBT for Depression - A Factorial Investigation of Kinds of Therapist Support and Self-/Expert-selected Content
Official Title
ICBT for Depression - A Factorial Investigation of Kinds of Therapist Support and Self-/Expert-selected Content
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 13, 2020 (Actual)
Primary Completion Date
April 15, 2021 (Actual)
Study Completion Date
April 15, 2021 (Actual)

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study is a factorial randomized controlled trial investigating the efficacy of difference versions of internet-administered cognitive behavioral therapy.
Detailed Description
The study is a 2 x 2 design. The first factor thought to be of relevance for the efficacy is the whether the content is selected by the participants themselves or by a therapist. The second factor consists of two levels: regular, continuous weekly support from a therapist or guidance on demand by a health care team consisting of a physician, a nurse, a clinical psychologist, an IT-technician and the principal investigator of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major, Depressive Symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Factor one: Regular therapist support by a therapist/On-demand guidance by a health care team (the participants themselves can choose to contact a physician, a nurse, a clinical psychologist, an IT-technician and/or the principal investigator of the study). Factor two: The content (the modules) is chosen by the participants themselves/The content is chosen by the therapist conducting the intake interview.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
246 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Expert-chosen content, regular guidance
Arm Type
Experimental
Arm Description
Content chosen by the therapist, weekly guidance by a therapist.
Arm Title
Expert-chosen content, on-demand guidance
Arm Type
Experimental
Arm Description
Content chosen by the therapist, guidance upon request from the health care team.
Arm Title
Participant-chosen content, regular guidance
Arm Type
Experimental
Arm Description
Content chosen by participants themselves, weekly guidance by a therapist.
Arm Title
Participant-chosen content, on-demand guidance
Arm Type
Experimental
Arm Description
Content chosen by participants themselves, guidance upon request from the health care team.
Intervention Type
Behavioral
Intervention Name(s)
Internet-administered Cognitive behavioral therapy (ICBT)
Intervention Description
The intervention consists of fifteen modules, each having a specific focus on a problem (e.g. comorbid worry alongside the depression) or containing a specific strategy or element (e.g. behavioral activation). The fifteen modules are: Introduction/Psychoeducation about depression, Behavioral activation 1, Behavioral activation 2, Cognitive restructuring, Acceptance, Psychoeducation about emotions, Anxiety and exposure, Comorbid social anxiety, Comorbid worrying and generalized anxiety, Comorbid panic disorder, Sleep problems, Perfectionism, Stress management, Relaxation, and Relapse prevention. The first and last module are assigned to all participants. The rest is picked either by the participants themselves or by the therapist conducting the intake interview.
Primary Outcome Measure Information:
Title
Change on Becks Depression Inventory-II (BDI-II)
Description
Measure of depressive symptoms. Possible range for the total sum: 0 to 63 (created by summing up the score from each item). Clinical ranges for minimal, mild, moderate and severe major depressive disorder are considered to be 0-13, 13-19, 20-28, and 29-63 points.
Time Frame
Baseline, after the intervention (after 11 weeks), 12 months after the end of intervention.
Title
Change on Patient Health Questionnaire (PHQ-9)
Description
Measure of depressive symptoms. Possible range for the total sum: 0 to 27 (created by summing up the score from each item). Clinical cut-offs for mild, moderate, moderately severe and severe major depressive disorder are considered to be 5, 10, 15, and 20 points.
Time Frame
Baseline, during week 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10 of the intervention, post-intervention (after 11 weeks), 12 months after the end of intervention.
Secondary Outcome Measure Information:
Title
Change on Generalised Anxiety Disorder 7-item scale (GAD-7)
Description
Measure of symptoms of generalised anxiety disorder (GAD). Seven items, the score is interpreted by summing up the score from each individual item. Higher scores indicate more severe problems with worry and generalised anxiety. The total sum ranges from 0 to 21 with cut-offs of 5, 10, and 15 representing mild, moderate and severe generalised anxiety.
Time Frame
Baseline, after the intervention (after 11 weeks), 12 months after the end of intervention.
Title
Change on Brunnsviken Brief Quality of Life Scale (BBQ)
Description
Measure of quality of life, total score ranging from 0 to 96 with a higher score indicating a higher quality of life. The scores of each of the six primary questions regarding perceived quality of life within an area of life are multiplied with the score of an item measuring the perceived importance of the area in question.
Time Frame
Baseline, after the intervention (after 11 weeks), 12 months after the end of intervention.
Title
Change on Insomnia Severity Index (ISI)
Description
Measure of insomnia severity and symptoms of disordered sleep. The total score can range between 0 (no sleep problems) to 28 (severe sleep problems and insomnia). Norm score ranges include low likelihood of sleep problems (0 to 7 points), some sleep problems (8 to 14 points), moderate sleep problems (15 to 21 points), severe sleep problems (22 to 28 points).
Time Frame
Baseline, after the intervention (after 11 weeks), 12 months after the end of intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Current depressive symptoms equivalent to a score of at least 5 on Patient Health Questionnaire 9 and a minimum of 10 points on Becks Depression Inventory. 18 years or older. Adequate ability to understand and speak Swedish. Access to the internet and a smartphone/computer. Exclusion Criteria: Other ongoing psychological treatment or counselling. Recent (within the past 3 months) changes in the dose of psychotropic medication. Prior diagnosis of psychosis, bipolar disorder, or substance dependence.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Andersson, PhD
Organizational Affiliation
Linkoeping University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Linköping University
City
Linköping
State/Province
Östergötland
ZIP/Postal Code
58330
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

ICBT for Depression - A Factorial Investigation of Kinds of Therapist Support and Self-/Expert-selected Content

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