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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Linkoeping University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Linkoeping University
ClinicalTrials.gov Identifier:
NCT01296321
First received: February 14, 2011
Last updated: February 15, 2011
Last verified: February 2011
History of Changes
  Purpose

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.


Condition Intervention
Anxiety Disorders
Depression
 Behavioral: Tailored Internet-administrated CBT-Treatment
Behavioral: Waitlist

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tailored Internet-administrated Treatment of Panic Symptoms - A Randomised Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Linkoeping University:

Primary Outcome Measures:
  • Panic Disorder Severity Scale (PDSS) [ Time Frame: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment ] [ Designated as safety issue: No ]
    Change from baseline in panic symptoms two weeks post treatment, at six months and at 12 months post treatment.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Change from baseline in anxiety and depressive symptoms two weeks post treatment, at six months and at 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 ] [ Designated as safety issue: No ]
    Change from baseline in anxiety symptoms two weeks post treatment, at six months and at 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 ] [ Designated as safety issue: No ]
    Change from baseline in depressive symptoms two weeks post treatment, at six months and at 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 ] [ Designated as safety issue: No ]
    Change from baseline in quality of life statements two weeks post treatment, at six months and at 12 months post treatment.


Enrollment: 57
Study Start Date: February 2010
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01296321

Sponsors and Collaborators
Linkoeping University
Investigators
Principal Investigator: Gerhard Andersson, PhD Department of Behavioral Sciences and Learning, Linköping University
  More Information

No publications provided by Linkoeping University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Gerhard Andersson/Professor, Linköping University
ClinicalTrials.gov Identifier: NCT01296321     History of Changes
Other Study ID Numbers: GA-FAS-2008-1145
Study First Received: February 14, 2011
Last Updated: February 15, 2011
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
 Mental Disorders
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on May 19, 2013