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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.

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 guidanceExpert-chosen content, regular guidanceParticipant-chosen content, on-demand guidanceParticipant-chosen content, regular guidance

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Study Design

Study Type

interventional

Phase

not applicable

Allocation

RANDOMIZED

Masking

NONE

Purpose

TREATMENT

Intervention Model

FACTORIAL

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.

Sponsor Type

OTHER GOV

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

Professor

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Study Arms (4)

Expert-chosen content, regular guidance

Expert-chosen content, on-demand guidance

Participant-chosen content, regular guidance

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Participant-chosen content, on-demand guidance

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Study Arms (4)

Expert-chosen content, regular guidance

Expert-chosen content, on-demand guidance

Participant-chosen content, regular guidance

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Participant-chosen content, on-demand guidance

You may not qualify if:

Data Sharing

Source record

Locations