NCT02363205

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 13, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

December 11, 2023

Status Verified

December 1, 2023

Enrollment Period

2.8 years

First QC Date

February 9, 2015

Last Update Submit

December 8, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Beck Depression Inventory

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

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

Secondary Outcomes (7)

  • Beck Anxiety Inventory (BAI)

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

  • Social Interaction Anxiety Scale (SIAS)

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

  • The General Self-Efficacy Scale (GSE)

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

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

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

  • Knowledge of CBT strategies (developed by the research group)

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

  • +2 more secondary outcomes

Study Arms (2)

control

NO INTERVENTION

Weekly check-up

internet-delivered CBT

EXPERIMENTAL

Tailored Internet-administrated CBT-Treatment

Behavioral: Tailored Internet-administrated CBT-Treatment

Interventions

Guided internet-delivered CBT with chat sessions

internet-delivered CBT

Eligibility Criteria

Age15 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Linköping University

Linköping, Östergotland, 58183, Sweden

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Gerhard Andersson

    Linkoeping University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 9, 2015

First Posted

February 13, 2015

Study Start

February 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

December 11, 2023

Record last verified: 2023-12

Locations