Tailored Internet-administrated Treatment of Panic Symptoms - A Randomised Controlled Trial (NOVA III)

February 15, 2011 updated by: Linkoeping University
The purpose of this study is to determine whether tailored internet-administrated CBT is a feasible approach in the treatment of panic symptoms and comorbid anxiety and depressive symptoms.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Be between the ages of 18-30 years old or 31-46 years old
  • Have reoccurring panic attacks

Exclusion Criteria:

  • Suicide prone
  • Alcohol addiction
  • PTSD
  • OCD
  • Ongoing psychological treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tailored Internet-delivered CBT
Behavioral: Tailored Internet-delivered CBT
Behavioral: Tailored Internet-administrated CBT-Treatment
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.
Active Comparator: Waitlist
Waitlist.
Behavioral: Waitlist
Passive waitlist during 8-10 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Panic Disorder Severity Scale (PDSS)
Time Frame: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
Change from baseline in panic 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Outcome in Routine Evaluation - Outcome Measure (CORE-OM)
Time Frame: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
Change from baseline in anxiety and depressive 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
Beck Anxiety Inventory (BAI)
Time Frame: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
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
Montgomery Åsberg Depression Rating Scale-Self Rated (MADRS-S)
Time Frame: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
Change from baseline in depressive 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
Quality of Life Inventory (QOLI)
Time Frame: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
Change from baseline in quality of life statements 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Linkoeping University

Investigators

  • Principal Investigator: Gerhard Andersson, PhD, Department of Behavioral Sciences and Learning, Linköping University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Anticipated)

April 1, 2011

Study Completion (Anticipated)

April 1, 2011

Study Registration Dates

First Submitted

February 14, 2011

First Submitted That Met QC Criteria

February 14, 2011

First Posted (Estimate)

February 15, 2011

Study Record Updates

Last Update Posted (Estimate)

February 16, 2011

Last Update Submitted That Met QC Criteria

February 15, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GA-FAS-2008-1145

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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