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

Primary Purpose

Anxiety Disorders, Depression

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tailored Internet-administrated CBT-Treatment
Waitlist
Sponsored by
Linkoeping University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Tailored Internet-delivered CBT

    Waitlist

    Arm Description

    Behavioral: Tailored Internet-delivered CBT

    Waitlist.

    Outcomes

    Primary Outcome Measures

    Panic Disorder Severity Scale (PDSS)
    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)
    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)
    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)
    Change from baseline in depressive symptoms two weeks post treatment, at six months and at 12 months post treatment.
    Quality of Life Inventory (QOLI)
    Change from baseline in quality of life statements two weeks post treatment, at six months and at 12 months post treatment.

    Full Information

    First Posted
    February 14, 2011
    Last Updated
    February 15, 2011
    Sponsor
    Linkoeping University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01296321
    Brief Title
    Tailored Internet-administrated Treatment of Panic Symptoms - A Randomised Controlled Trial
    Acronym
    NOVA III
    Official Title
    Tailored Internet-administrated Treatment of Panic Symptoms - A Randomised Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2011
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2010 (undefined)
    Primary Completion Date
    April 2011 (Anticipated)
    Study Completion Date
    April 2011 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Linkoeping University

    4. Oversight

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    57 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Tailored Internet-delivered CBT
    Arm Type
    Experimental
    Arm Description
    Behavioral: Tailored Internet-delivered CBT
    Arm Title
    Waitlist
    Arm Type
    Active Comparator
    Arm Description
    Waitlist.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Tailored Internet-administrated CBT-Treatment
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Waitlist
    Intervention Description
    Passive waitlist during 8-10 weeks.
    Primary Outcome Measure Information:
    Title
    Panic Disorder Severity Scale (PDSS)
    Description
    Change from baseline in panic symptoms two weeks post treatment, at six months and at 12 months post treatment.
    Time Frame
    Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
    Secondary Outcome Measure Information:
    Title
    Clinical Outcome in Routine Evaluation - Outcome Measure (CORE-OM)
    Description
    Change from baseline in anxiety and depressive symptoms two weeks post treatment, at six months and at 12 months post treatment.
    Time Frame
    Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
    Title
    Beck Anxiety Inventory (BAI)
    Description
    Change from baseline in anxiety symptoms two weeks post treatment, at six months and at 12 months post treatment.
    Time Frame
    Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
    Title
    Montgomery Åsberg Depression Rating Scale-Self Rated (MADRS-S)
    Description
    Change from baseline in depressive symptoms two weeks post treatment, at six months and at 12 months post treatment.
    Time Frame
    Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
    Title
    Quality of Life Inventory (QOLI)
    Description
    Change from baseline in quality of life statements two weeks post treatment, at six months and at 12 months post treatment.
    Time Frame
    Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gerhard Andersson, PhD
    Organizational Affiliation
    Department of Behavioral Sciences and Learning, Linköping University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22732098
    Citation
    Silfvernagel K, Carlbring P, Kabo J, Edstrom S, Eriksson J, Manson L, Andersson G. Individually tailored internet-based treatment for young adults and adults with panic attacks: randomized controlled trial. J Med Internet Res. 2012 Jun 26;14(3):e65. doi: 10.2196/jmir.1853.
    Results Reference
    derived

    Learn more about this trial

    Tailored Internet-administrated Treatment of Panic Symptoms - A Randomised Controlled Trial

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