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Completed

NCT Number: NCT03061448

Internet-based Exposure Therapy for Panic Disorder

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet

Stockholm, 17177, Sweden

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Internet-based cognitive-behavior therapy

Behavioral

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Internet-based Exposure Therapy for Panic Disorder: A Randomized Controlled Pilot Study

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 23, 2017
Registry last updated
Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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