Panic Disorder With AgoraphobiaNCT03061448
Internet-based Exposure Therapy for Panic Disorder
A study testing Internet-based cognitive-behavior therapy in people with Panic Disorder With Agoraphobia, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Panic Disorder With Agoraphobia
- What is being tested?
- Internet-based cognitive-behavior therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2017to 1 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients
- ≥ 18 years
- Situated in Sweden
- Informed consent
- Panic Disorder Severity Scale - self rated score more than 6 points
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Internet-based Exposure Therapy for Panic Disorder: A Randomized Controlled Pilot Study
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.
Read the 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
- Conditions
- Panic Disorder With Agoraphobia
- Being tested
- Internet-based cognitive-behavior therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based cognitive-behavior therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Inhibitory learning based treatment | Experimental | 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. Receives: Behavioral: Internet-based cognitive-behavior therapy |
| Habituation based treatment | Active comparator | 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). Receives: Behavioral: Internet-based cognitive-behavior therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Panic Disorder Severity Scale - Self rated (PDSS-SR)
Change in panic symptoms from baseline to Week 8
Measured: Week 0, Week 8
Secondary outcomes (12)
Credibility/Expectancy Questionnaire (CEQ)
Measuring treatment expectancy and rationale credibility for use in clinical outcome studies
Measured: Week 2
Client Satisfaction Questionnaire (CSQ)
To assess client satisfaction with treatment
Measured: Week 8
Adverse events scale
To assess any adverse events caused by the treatment
Measured: Week 8
Patient Health Questionnaire (PHQ-9)
Change in depression from baseline to Week 8
Measured: Week 0, Week 8
Anxiety Sensitivity Index (ASI)
Change in fear of anxiety-related physical sensations
Measured: Week 0, Week 8
Agoraphobic Cognitions Questionnaire (ACQ)
Change in fear of fear in agoraphobics
Measured: Week 0, Week 8
Body Sensations Questionnaire (BSQ)
Change in fear of bodily sensations in agoraphobics
Measured: Week 0, Week 8
Brunnsviken Quality of Life Questionnaire (BBQ)
Change in self-perceived quality of life from baseline to week 8
Measured: Week 0, Week 8
WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
Change in functioning and disability
Measured: Week 0, Week 8
Generalised Anxiety Disorder Assessment (GAD-7)
Screening tool and severity measure for generalised anxiety disorder
Measured: Week 0, Week 8
The Cardiac Anxiety Questionnaire (CAQ)
Change in heart-focused anxiety from baseline to week 8
Measured: Week 0, Week 8
HA-NI-SSD Symptom Preoccupation Scale - testversion (SPSt)
Change in preoccupation of symptoms from baseline to week 8
Measured: Week 0, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start1 Feb 2017
- Primary completion1 Jun 2017
- Study completion1 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Panic Disorder With AgoraphobiaStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erik Andersson, Karolinska Institutet
- Investigators
- Erik M Andersson, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03061448
- Sponsor's protocol ID
- 2016/2422-31
- Status last verified
- Aug 2017
- First submitted
- 19 Feb 2017
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Exposure Therapy for Panic Disorder: A Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT03061448
- Acronym / sponsor ID
- 2016/2422-31
- Conditions
- Panic Disorder With Agoraphobia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhibitory learning based treatment | Experimental | Behavioral: Internet-based cognitive-behavior therapyThe 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. |
| Habituation based treatment | Active comparator | Behavioral: Internet-based cognitive-behavior therapyThe 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Outpatients
- ≥ 18 years
- Situated in Sweden
- Informed consent
- Panic Disorder Severity Scale - self rated score more than 6 points
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-based cognitive-behavior therapyInternet-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. | Behavioural | Habituation based treatment, Inhibitory learning based treatment |
Primary outcome
Panic Disorder Severity Scale - Self rated (PDSS-SR)
Time frame: Week 0, Week 8
Change in panic symptoms from baseline to Week 8
12 secondary outcomes
Credibility/Expectancy Questionnaire (CEQ)
Time frame: Week 2
Client Satisfaction Questionnaire (CSQ)
Time frame: Week 8
Adverse events scale
Time frame: Week 8
Patient Health Questionnaire (PHQ-9)
Time frame: Week 0, Week 8
Anxiety Sensitivity Index (ASI)
Time frame: Week 0, Week 8
Agoraphobic Cognitions Questionnaire (ACQ)
Time frame: Week 0, Week 8
Body Sensations Questionnaire (BSQ)
Time frame: Week 0, Week 8
Brunnsviken Quality of Life Questionnaire (BBQ)
Time frame: Week 0, Week 8
WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
Time frame: Week 0, Week 8
Generalised Anxiety Disorder Assessment (GAD-7)
Time frame: Week 0, Week 8
The Cardiac Anxiety Questionnaire (CAQ)
Time frame: Week 0, Week 8
HA-NI-SSD Symptom Preoccupation Scale - testversion (SPSt)
Time frame: Week 0, Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik M Andersson, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based cognitive-behavior therapy in people with Panic Disorder With Agoraphobia, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Panic Disorder Severity Scale - Self rated (PDSS-SR) (time frame: Week 0, Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2017.