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

NCT04260750 | Completed

• 1 other identifier: LUNA
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a factorial randomized controlled trial investigating the efficacy of difference versions of internet-administered cognitive behavioral therapy.

Conditions

Depressive Disorder, Major; Depressive Symptoms

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline, after the intervention (after 11 weeks), 12 months after the end of intervention.

• 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.

  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 Outcomes (3)

• Change on Generalised Anxiety Disorder 7-item scale (GAD-7)

  Baseline, after the intervention (after 11 weeks), 12 months after the end of intervention.

• Change on Brunnsviken Brief Quality of Life Scale (BBQ)

  Baseline, after the intervention (after 11 weeks), 12 months after the end of intervention.

• Change on Insomnia Severity Index (ISI)

  Baseline, after the intervention (after 11 weeks), 12 months after the end of intervention.

Study Arms (4)

Expert-chosen content, regular guidance

EXPERIMENTAL

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

Behavioral: Internet-administered Cognitive behavioral therapy (ICBT)

Expert-chosen content, on-demand guidance

EXPERIMENTAL

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

Behavioral: Internet-administered Cognitive behavioral therapy (ICBT)

Participant-chosen content, regular guidance

EXPERIMENTAL

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

Behavioral: Internet-administered Cognitive behavioral therapy (ICBT)

Participant-chosen content, on-demand guidance

EXPERIMENTAL

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

Behavioral: Internet-administered Cognitive behavioral therapy (ICBT)

Interventions

Internet-administered Cognitive behavioral therapy (ICBT) BEHAVIORAL

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.

Expert-chosen content, on-demand guidance; Expert-chosen content, regular guidance; Participant-chosen content, on-demand guidance; Participant-chosen content, regular guidance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• years or older.
• Adequate ability to understand and speak Swedish.
• Access to the internet and a smartphone/computer.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Linkoeping University: lead

Study Sites (1)

Linköping University

Linköping, Östergötland County, 58330, Sweden

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Gerhard Andersson, PhD

  Linkoeping University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 30, 2020
• First Posted: February 7, 2020
• Study Start: January 13, 2020
• Primary Completion: April 15, 2021
• Study Completion: April 15, 2021
• Last Updated: April 20, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)