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Trial record 44 of 179 for:    "Panic Disorder"

Internet-based Exposure Therapy for Panic Disorder

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ClinicalTrials.gov Identifier: NCT03061448
Recruitment Status : Completed
First Posted : February 23, 2017
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
Erik Andersson, Karolinska Institutet

Brief Summary:
The purpose of this study is examine if an internet-based exposure therapy based on inhibitory learning is feasible, acceptable and effective in reducing panic symptoms amongst patients who suffer from panic disorder and agoraphobia.

Condition or disease Intervention/treatment Phase
Panic Disorder With Agoraphobia Behavioral: Internet-based cognitive-behavior therapy Not Applicable

Detailed Description:

Trial objectives: Primary objective is to examine if an internet-based exposure therapy based on inhibitory learning is effective in reducing panic symptoms. The secondary objective is to study if the protocol is feasible and acceptable. Secondary objective is measured is examined on 1) number of participants completing the study protocol, 2) participants' satisfaction with the treatment, 3) therapists' ratings of acceptability. The aim of this study is to assess the feasibility, and pilot the design and delivery of a RCT that will subsequently form the framework for a larger RCT to evaluate the effectiveness of an exposure protocol based on inhibitory learning.

Trial Design: Randomized controlled pilot study with two groups randomly assigned to either Internet-based exposure therapy based on the principles of inhibitory learning or Internet-based exposure therapy based on the principles of habituation Duration: Eight weeks Primary Endpoint: Change in panic symptoms from baseline to Week 8. Efficacy Parameters: Panic Disorder Severity Scale - Self rated (PDSS-SR) Safety Parameters: Adverse Events is assessed weekly via the internet. Description of Trial Subjects: Patients > 18 years old with a PDSS-SR score more than 6 points Number of Subjects: 80


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Internet-based Exposure Therapy for Panic Disorder: A Randomized Controlled Pilot Study
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : June 1, 2017
Actual Study Completion Date : June 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Panic Disorder

Arm Intervention/treatment
Experimental: Inhibitory learning based treatment
The experimental group will go through Internet-based treatment. The exposure treatment is 8 weeks long and based on the principles of inhibitory learning, i.e. the participant is instructed to stay in the frightening situation until his/her expectancy has been maximally violated.
Behavioral: Internet-based cognitive-behavior therapy
Internet-based cognitive-behavior therapy on a safe internet platform. Treatment is divided into eight modules, each containing homework assignments . The participants will be assigned a therapist that they can contact through a message system in the platform and expect answer within 24 hours.

Active Comparator: Habituation based treatment
The active comparator group will also go through Internet-based treatment. The exposure treatment is 8 weeks long and based on the principles of emotional processing theory, i.e. the participant is instructed to stay in the frightening situation until anxiety has declined (habituated).
Behavioral: Internet-based cognitive-behavior therapy
Internet-based cognitive-behavior therapy on a safe internet platform. Treatment is divided into eight modules, each containing homework assignments . The participants will be assigned a therapist that they can contact through a message system in the platform and expect answer within 24 hours.




Primary Outcome Measures :
  1. Panic Disorder Severity Scale - Self rated (PDSS-SR) [ Time Frame: Week 0, Week 8 ]
    Change in panic symptoms from baseline to Week 8


Secondary Outcome Measures :
  1. Credibility/Expectancy Questionnaire (CEQ) [ Time Frame: Week 2 ]
    Measuring treatment expectancy and rationale credibility for use in clinical outcome studies

  2. Client Satisfaction Questionnaire (CSQ) [ Time Frame: Week 8 ]
    To assess client satisfaction with treatment

  3. Adverse events scale [ Time Frame: Week 8 ]
    To assess any adverse events caused by the treatment

  4. Patient Health Questionnaire (PHQ-9) [ Time Frame: Week 0, Week 8 ]
    Change in depression from baseline to Week 8

  5. Anxiety Sensitivity Index (ASI) [ Time Frame: Week 0, Week 8 ]
    Change in fear of anxiety-related physical sensations

  6. Agoraphobic Cognitions Questionnaire (ACQ) [ Time Frame: Week 0, Week 8 ]
    Change in fear of fear in agoraphobics

  7. Body Sensations Questionnaire (BSQ) [ Time Frame: Week 0, Week 8 ]
    Change in fear of bodily sensations in agoraphobics

  8. Brunnsviken Quality of Life Questionnaire (BBQ) [ Time Frame: Week 0, Week 8 ]
    Change in self-perceived quality of life from baseline to week 8

  9. WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) [ Time Frame: Week 0, Week 8 ]
    Change in functioning and disability

  10. Generalised Anxiety Disorder Assessment (GAD-7) [ Time Frame: Week 0, Week 8 ]
    Screening tool and severity measure for generalised anxiety disorder

  11. The Cardiac Anxiety Questionnaire (CAQ) [ Time Frame: Week 0, Week 8 ]
    Change in heart-focused anxiety from baseline to week 8

  12. HA-NI-SSD Symptom Preoccupation Scale - testversion (SPSt) [ Time Frame: Week 0, Week 8 ]
    Change in preoccupation of symptoms from baseline to week 8



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Outpatients
  • ≥ 18 years
  • Situated in Sweden
  • Informed consent
  • Panic Disorder Severity Scale - self rated score more than 6 points

Exclusion Criteria:

  • Substance dependence during the last six months
  • Post traumatic stress disorder, bipolar disorder or psychosis
  • Symptoms better explained by axis 2 diagnosis (e.g. autism or borderline personality disorder)
  • MADRS-S score above 25 points
  • Psychotropic medication changes within one months prior to treatment that could affect target symptoms.
  • Received exposure based Cognitive behavior therapy (CBT) for pathological worry the last 2 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03061448


Locations
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Sweden
Karolinska Institutet
Stockholm, Sweden, 17177
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: Erik M Andersson, PhD Karolinska Institutet

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Responsible Party: Erik Andersson, PhD, psychologist, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03061448     History of Changes
Other Study ID Numbers: 2016/2422-31
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Disease
Panic Disorder
Agoraphobia
Pathologic Processes
Anxiety Disorders
Mental Disorders