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

NCT ID: NCT04260750

Last Updated: 2021-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 246 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-13
• Study Completion Date: 2021-04-15

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.

Conditions

Depressive Disorder, Major; Depressive Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Expert-chosen content, regular guidance

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

Group Type: EXPERIMENTAL

Internet-administered Cognitive behavioral therapy (ICBT)

Intervention Type: 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

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

Group Type: EXPERIMENTAL

Internet-administered Cognitive behavioral therapy (ICBT)

Intervention Type: 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.

Participant-chosen content, regular guidance

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

Group Type: EXPERIMENTAL

Internet-administered Cognitive behavioral therapy (ICBT)

Intervention Type: 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.

Participant-chosen content, on-demand guidance

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

Group Type: EXPERIMENTAL

Internet-administered Cognitive behavioral therapy (ICBT)

Intervention Type: 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.

Interventions

Internet-administered Cognitive behavioral therapy (ICBT)

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Linkoeping University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Gerhard Andersson

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gerhard Andersson, PhD

Role: PRINCIPAL_INVESTIGATOR

Linkoeping University

Locations

Linköping University

Linköping, Östergötland County, Sweden

Countries

Sweden

Other Identifiers

LUNA

Identifier Type: -

Identifier Source: org_study_id