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Internet-Delivered Cognitive Behaviour Therapy for Adolescent Depression

Primary Purpose

Depression, Anxiety

Status

Unknown status

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Tailored Internet-administrated CBT-Treatment

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

15 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Be between the ages of 15-19 years old
Have symptoms of depression, major depression

Exclusion Criteria:

Suicidal ideation
Alcohol addiction
other major primary psychiatric disorder
Ongoing psychological treatment
recent (during last 4 weeks) change in psychiatric medication

Sites / Locations

Linköping University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control

internet-delivered CBT

Arm Description

Weekly check-up

Tailored Internet-administrated CBT-Treatment

Outcomes

Primary Outcome Measures

Beck Depression Inventory

Change from baseline to post treatment, six months and 12 months post treatment.

Secondary Outcome Measures

Beck Anxiety Inventory (BAI)

Change from baseline to post treatment, six months and 12 months post treatment.

Social Interaction Anxiety Scale (SIAS)

Change from baseline to post treatment, six months and 12 months post treatment.

The General Self-Efficacy Scale (GSE)

Change from baseline to post treatment, six months and 12 months post treatment.

Subscale Life activites, WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)

Change from baseline to post treatment, six months and 12 months post treatment.

Knowledge of CBT strategies (developed by the research group)

Change from baseline to post treatment, six months and 12 months post treatment.

Patient Health Questionnaire (PHQ)

Change from baseline to post treatment

The Mood and Feelings Questionnaire (MFQ)

Change from baseline to post treatment, six months and 12 months post treatment.

Full Information

NCT ID

NCT02363205

First Posted

February 9, 2015

Last Updated

September 3, 2017

Sponsor

Linkoeping University

1. Study Identification

Unique Protocol Identification Number

NCT02363205

Brief Title

Internet-Delivered Cognitive Behaviour Therapy for Adolescent Depression

Official Title

Guided Internet-Delivered and Tailored Cognitive Behaviour Therapy for Adolescents With Depression: a Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Unknown status

Study Start Date

February 2015 (Actual)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Linkoeping University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine whether tailored internet-administrated cognitive behaviour therapy (CBT) is a feasible approach in the treatment of depressive symptoms and comorbid anxiety symptoms.

Detailed Description

As above

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression, Anxiety

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

control

Arm Type

No Intervention

Arm Description

Weekly check-up

Arm Title

internet-delivered CBT

Arm Type

Experimental

Arm Description

Tailored Internet-administrated CBT-Treatment

Intervention Type

Behavioral

Intervention Name(s)

Tailored Internet-administrated CBT-Treatment

Intervention Description

Guided internet-delivered CBT with chat sessions

Primary Outcome Measure Information:

Title

Beck Depression Inventory

Description

Change from baseline to post treatment, six months and 12 months post treatment.

Time Frame

Baseline, post treatment, 6 months- and 12 months post treatment

Secondary Outcome Measure Information:

Title

Beck Anxiety Inventory (BAI)

Description

Change from baseline to post treatment, six months and 12 months post treatment.

Time Frame

Baseline, post treatment, 6 months- and 12 months post treatment

Title

Social Interaction Anxiety Scale (SIAS)

Description

Change from baseline to post treatment, six months and 12 months post treatment.

Time Frame

Baseline, post treatment, 6 months- and 12 months post treatment

Title

The General Self-Efficacy Scale (GSE)

Description

Change from baseline to post treatment, six months and 12 months post treatment.

Time Frame

Baseline, post treatment, 6 months- and 12 months post treatment

Title

Subscale Life activites, WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)

Description

Change from baseline to post treatment, six months and 12 months post treatment.

Time Frame

Baseline, post treatment, 6 months- and 12 months post treatment

Title

Knowledge of CBT strategies (developed by the research group)

Description

Change from baseline to post treatment, six months and 12 months post treatment.

Time Frame

Baseline, post treatment, 6 months- and 12 months post treatment

Title

Patient Health Questionnaire (PHQ)

Description

Change from baseline to post treatment

Time Frame

Baseline, post treatment, 6 months- and 12 months post treatment

Title

The Mood and Feelings Questionnaire (MFQ)

Description

Change from baseline to post treatment, six months and 12 months post treatment.

Time Frame

Baseline, post treatment, 6 months- and 12 months post treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Be between the ages of 15-19 years old Have symptoms of depression, major depression Exclusion Criteria: Suicidal ideation Alcohol addiction other major primary psychiatric disorder Ongoing psychological treatment recent (during last 4 weeks) change in psychiatric medication

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gerhard Andersson

Organizational Affiliation

Linkoeping University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Linköping University

City

Linköping

State/Province

Östergotland

ZIP/Postal Code

58183

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

31682572

Citation

Topooco N, Bylehn S, Dahlstrom Nysater E, Holmlund J, Lindegaard J, Johansson S, Aberg L, Bergman Nordgren L, Zetterqvist M, Andersson G. Evaluating the Efficacy of Internet-Delivered Cognitive Behavioral Therapy Blended With Synchronous Chat Sessions to Treat Adolescent Depression: Randomized Controlled Trial. J Med Internet Res. 2019 Nov 1;21(11):e13393. doi: 10.2196/13393.

Results Reference

derived

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Internet-Delivered Cognitive Behaviour Therapy for Adolescent Depression

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