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Completed

NCT Number: NCT04260750

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

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

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Key information

Conditions

Depressive Disorder, Major Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Symptoms Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Linköping University

Linköping, Östergötland County, 58330, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change on Becks Depression Inventory-II (BDI-II)

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

    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.

  2. Change on Patient Health Questionnaire (PHQ-9)

    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.

    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 outcomes

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

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

    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.

  2. Change on Brunnsviken Brief Quality of Life Scale (BBQ)

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

    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.

  3. Change on Insomnia Severity Index (ISI)

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

    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).

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 7, 2020
Registry last updated
Apr 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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