NCT01402258

Brief Summary

The purpose of this study is to determine whether tailored internet-administrated CBT is a feasible approach in the treatment of anxiety symptoms and comorbid anxiety and depressive symptoms in a clinical setting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2011

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2011

Completed
25 days until next milestone

First Posted

Study publicly available on registry

July 26, 2011

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

December 14, 2023

Status Verified

December 1, 2023

Enrollment Period

3.7 years

First QC Date

July 1, 2011

Last Update Submit

December 8, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Beck Anxiety Inventory (BAI)- Change from baseline

    Change from baseline in anxiety symptoms two weeks post treatment, at six months and at 12 months post treatment.

    Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment

Secondary Outcomes (3)

  • Quality of Life Inventory (QOLI)- Change from baseline

    Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment

  • Montgomery Åsberg Depression Rating Scale-Self Rated (MADRS-S)- Change from baseline

    Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment

  • Clinical Outcome in Routine Evaluation - Outcome Measure (CORE-OM)- Change from baseline

    Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment

Study Arms (1)

Tailored Internet-delivered CBT

EXPERIMENTAL

Behavioral: Tailored Internet-delivered CBT

Behavioral: Tailored Internet-administrated CBT-Treatment

Interventions

This intervention contains 6-8 text-based self-help modules in which 4 modules are fixed (the first three and the last) and the rest are prescribed following the diagnostic telephone interview. These modules contain material on panic disorder, social phobia, stress management, assertiveness training, concentration, relaxation among other things.

Tailored Internet-delivered CBT

Eligibility Criteria

Age16 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Be between the ages of 16-25 years old
  • Have anxiety symptoms and/or anxiety syndrome

You may not qualify if:

  • Suicide prone
  • Alcohol addiction
  • Ongoing psychological treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Behavioral Sciences and Learning, Linköping University

Linköping, Östergötland County, 58183, Sweden

Location

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • Gerhard Andersson, PhD

    Department of Behavioral Sciences and Learning, Linköping University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 1, 2011

First Posted

July 26, 2011

Study Start

April 1, 2011

Primary Completion

December 1, 2014

Study Completion

June 1, 2015

Last Updated

December 14, 2023

Record last verified: 2023-12

Locations