Clinical trial NCT04260750: 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
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Disorder, Major
Depressive Symptoms
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2020-02-07
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change on Becks Depression Inventory-II (BDI-II)
timeFrame: Baseline, after the intervention (after 11 weeks), 12 months after the end of intervention.
measure: Change on Patient Health Questionnaire (PHQ-9)
timeFrame: 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:
measure: Change on Generalised Anxiety Disorder 7-item scale (GAD-7)
timeFrame: Baseline, after the intervention (after 11 weeks), 12 months after the end of intervention.
measure: Change on Brunnsviken Brief Quality of Life Scale (BBQ)
timeFrame: Baseline, after the intervention (after 11 weeks), 12 months after the end of intervention.
measure: Change on Insomnia Severity Index (ISI)
timeFrame: Baseline, after the intervention (after 11 weeks), 12 months after the end of intervention.
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Linköping University
state: Östergötland
Study officials:
affiliation: Linkoeping University
name: Gerhard Andersson, PhD
role: PRINCIPAL_INVESTIGATOR
References: