Panic DisorderNCT02402322
Internet-based Self-help Treatment for Panic Disorder: Two Ways of Complementary Psychological Support
A study testing Scheduled support and Non-scheduled support in people with Panic Disorder, run by Universitat Autonoma de Barcelona.
Trial summary
The aim of this study was to compare two ways of administrating the complementary psychological support (scheduled vs. non-scheduled) in an online self-help program for panic disorder. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Panic Disorder
- What is being tested?
- Scheduled support and Non-scheduled support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- No sites listed yet
- Study dates
- Aug 2013to Nov 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Meet Diagnostic Statistical Manual criteria for panic disorder.
- Have suffered from panic disorder at least one year.
- Suffer from panic disorder as primary pathology.
- If the participant was taking medication for panic disorder / agoraphobia, the dose should be stable three months before the start of the program.
Who cannot join
- Obtain a score of 26 or more on the Beck Depression Inventory II
- Suffer from another psychiatric illness that requires immediate attention.
- Risk of suicide, indicated by a score of 3 on the screening questionnaire.
- Being or having been in cognitive behavioral therapy .
About this study
Official title: Internet-based Self-help Treatment for Panic Disorder: A Randomised Controlled Trial of Two Ways of Administrating the Complementary Psychological Support (Scheduled vs. Non-scheduled)
The aim of this study was to compare two ways of administrating the complementary psychological support (scheduled vs. non-scheduled) in an online self-help program for panic disorder. In order to do so, the investigators studied: a) If there were differences in the intensity and frequency of the symptoms of panic disorder. b) If there were differences in the therapeutic adherence between the subjects receiving both kinds of complementary support. c) If the more time spent by a psychologist in therapeutic interventions produced the best results of therapeutic adherence / symptom improvement.
Seventy seven subjects followed the online self-help program for 8 weeks; 27 subjects had the support of a therapist via phone when they required it, 25 subjects had the support of a therapist weekly and 25 subjects were in the waiting list as a control group.
Read the detailed description
The aim of this study was to compare two ways of administrating the complementary psychological support (scheduled vs. non-scheduled) in an online self-help program for panic disorder. In order to do so, the investigators studied: a) If there were differences in the intensity and frequency of the symptoms of panic disorder. b) If there were differences in the therapeutic adherence between the subjects receiving both kinds of complementary support. c) If the more time spent by a psychologist in therapeutic interventions produced the best results of therapeutic adherence / symptom improvement.
Treatment program
Internet-based self-help program for anxiety disorders "FREE OF ANXIETY" was developed, based on cognitive behavioral therapy. The program is presented as an interactive course, which is divided into eight weekly modules.A number of therapeutic components are used: psychological education (modules 1-8), behavioral analysis (safety and avoidance behavior) (module 2), in vivo and interoceptive exposure (modules 2-8), relaxation training and diaphragmatic breathing (modules 1-4), cognitive restructuring (modules 4-5), mindfulness (Module 6) communication training (module 7), problem solving Module 8). The program also includes a messaging system between therapists and subjects.
Participants and Procedure
The participants were recruited using a google banner linked to searches about anxiety disorders. The individuals were redirected to a Web page which contained information about anxiety disorders and the aims of the study. Suicide risk (score of 3 in the 15th item of the Web Screening Questionnaire) was established as an exclusion criterion. The study was approved by the ethics committee of the Autonomous University of Barcelona.
Applicants completed the informed consent, the demographic questionnaire and a screening questionnaire online. One week later a psychologist who had been trained to apply the MINI International Neuropsychiatric Interview (Sheehan, Lecrubier, Harnett-Sheehan, Janavs,Weiller, Bonora, et al., 1997) assessed the presence of a current psychiatric diagnosis. Participants with Panic Disorder completed a battery of self-reported measures in order to assess panic disorder, anxiety, and depression symptoms.
After clinical evaluation, the participants were divided into three groups by a true random-number service.
The data collected were anonymized and coded
Seventy seven subjects followed the online self-help program for 8 weeks; 27 subjects had the support of a therapist via phone when they required it, 25 subjects had the support of a therapist weekly and 25 subjects were in the waiting list as a control group.
Participants completed self-reported measures at the end of the treatment, and six months later.
Statistical analyses
The investigators studied differences between participants with and without Panic Disorder regarding their gender and age, using Chi-square test and Student t-test.
The participants' pretreatment and posttreatment measures were analyzed with analysis of variance (ANOVA) with repeated measures. These were followed by t tests with Bonferroni-corrected p values. Effect sizes were calculated both within and between groups, and all calculations were based on the pooled standard deviation, Cohen's d.
All analyses were conducted using SPSS version 22 for Windows.
- Conditions
- Panic Disorder
- Being tested
- Scheduled support, Non-scheduled support
- Medical subject headings
- Panic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scheduled supportBehavioural
Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly.
Non-scheduled supportBehavioural
Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it.
| Study group | Role | What they receive |
|---|---|---|
| Non-scheduled support | Active comparator | Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it. Receives: Behavioral: Non-scheduled support |
| Scheduled support | Experimental | Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly. Receives: Behavioral: Scheduled support |
| Waiting list | No intervention | Participants in a waiting list. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline Score in the Panic Disorder Severity Scale at 8 Weeks and 6 Months.
Panic Disorder Severity Scale Self-Report (PDSS-SR). This 7-item scale assesses the severity of PD through questions about the frequency of panic attacks, associated distress, anticipatory anxiety, agoraphobic and interoceptive avoidance, and social and work impairment. Score range: 0-28. Scores up to 10 correspond with ''mild,'' those between 11 and 15 with ''moderate,'' and those at or above 16 with ''severe'' panic disorder.
Measured: Baseline, 8 weeks, 6 months.
Change From Baseline Score in the Anxiety Sensitivity Index-3 at 8 Weeks and 6 Months.
This 18-item scale evaluates sensitivity to anxiety symptoms on 3 dimensions: physical, cognitive, and social.There are 3 subscales, physical, cognitive, and social. For both the subscales (which range from 0 to 24) and the total scale (which range from 0 to 72), higher scores correspond to greater anxiety sensitivity.
Measured: Baseline, 8 weeks, 6 months.
Secondary outcomes (7)
Change From Baseline Score in the Beck Anxiety Inventory at 8 Weeks and 6 Months.
Beck Anxiety Inventory (BAI), Spanish adaptation . This 21-item self-reported instrument evaluates the cognitive and physical symptoms of anxiety. Score range:0- 63, with 3 levels of severity 0-21 mild anxiety, 22-35 moderate anxiety and 36-63 severe anxiety.
Measured: Baseline, 8 weeks, 6 months.
Change From Baseline Score in the Beck Depression Inventory at 8 Weeks and 6 Months.
Beck Depression Inventory-II (BDI-II), Spanish adaptation (38, 39). This 21-item self-reported instrument evaluates symptoms of depression. Score range:0- 63, with 3 levels of severity, 10-18 mild depression, 19-29 moderate depression and >30 severe depression.
Measured: Baseline, 8 weeks, 6 months.
Change From Baseline Score in the Sheehan Disability Inventory (Work Subscale) at 8 Weeks and 6 Months.
This 5-item instrument assesses functional impairment at work, and in social and family life. There are 5 subscales: work, social life, family life, stress, social support. The first three subscales range from 0 to 10, with higher scores indicating greater disability. The fourth subscale (stress) range from 0 to 10, with higher scores indicating greater stress perceived. The fifth subscale (Social Support Subscale) ranges from 0 to 100, with higher scores indicating greater social support perceived.There is not a total score.
Measured: Baseline, 8 weeks, 6 months.
Change From Baseline Score in the Sheehan Disability Inventory (Social Life Subscale) at 8 Weeks and 6 Months.
This 5-item instrument assesses functional impairment at work, and in social and family life. There are 5 subscales: work, social life, family life, stress, social support. The first three subscales range from 0 to 10, with higher scores indicating greater disability. The fourth subscale (stress) range from 0 to 10, with higher scores indicating greater stress perceived. The fifth subscale (Social Support Subscale) ranges from 0 to 100, with higher scores indicating greater social support perceived.There is not a total score.
Measured: Baseline, 8 weeks, 6 months.
Change From Baseline Score in the Sheehan Disability Inventory (Family Subscale) at 8 Weeks and 6 Months.
This 5-item instrument assesses functional impairment at work, and in social and family life. There are 5 subscales: work, social life, family life, stress, social support. The first three subscales range from 0 to 10, with higher scores indicating greater disability. The fourth subscale (stress) range from 0 to 10, with higher scores indicating greater stress perceived. The fifth subscale (Social Support Subscale) ranges from 0 to 100, with higher scores indicating greater social support perceived.There is not a total score.
Measured: Baseline, 8 weeks, 6 months.
Change From Baseline Score in the Sheehan Disability Inventory (Stress Subscale) at 8 Weeks and 6 Months.
This 5-item instrument assesses functional impairment at work, and in social and family life. There are 5 subscales: work, social life, family life, stress, social support. The first three subscales range from 0 to 10, with higher scores indicating greater disability. The fourth subscale (stress) range from 0 to 10, with higher scores indicating greater stress perceived. The fifth subscale (Social Support Subscale) ranges from 0 to 100, with higher scores indicating greater social support perceived.There is not a total score.
Measured: Baseline, 8 weeks, 6 months.
Change From Baseline Score in the Sheehan Disability Inventory (Social Support Subscale) at 8 Weeks and 6 Months.
This 5-item instrument assesses functional impairment at work, and in social and family life. There are 5 subscales: work, social life, family life, stress, social support. The first three subscales range from 0 to 10, with higher scores indicating greater disability. The fourth subscale (stress) range from 0 to 10, with higher scores indicating greater stress perceived. The fifth subscale (Social Support Subscale) ranges from 0 to 100, with higher scores indicating greater social support perceived.There is not a total score.
Measured: Baseline, 8 weeks, 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study startAug 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Panic DisorderStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Autonoma de Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pablo Oromendia, Universitat Autonoma de Barcelona
- Investigators
- Beatriz Molinuevo, PhD, Study director, Department of Psychiatry and Forensic Medicine, Institute of Neurosciences, School of Medicine, Universitat Autònoma de Barcelona, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02402322
- Sponsor's protocol ID
- PTCCAP
- Status last verified
- Oct 2015
- First submitted
- 20 Mar 2015
- Last updated
- 7 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Self-help Treatment for Panic Disorder: A Randomised Controlled Trial of Two Ways of Administrating the Complementary Psychological Support (Scheduled vs. Non-scheduled)
- ClinicalTrials.gov ID
- NCT02402322
- Acronym / sponsor ID
- PTCCAP
- Conditions
- Panic Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Universitat Autonoma de BarcelonaUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 30 Mar 2015 (estimated)
- Results
- Posted 7 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was to compare two ways of administrating the complementary psychological support (scheduled vs. non-scheduled) in an online self-help program for panic disorder. In order to do so, the investigators studied: a) If there were differences in the intensity and frequency of the symptoms of panic disorder. b) If there were differences in the therapeutic adherence between the subjects receiving both kinds of complementary support. c) If the more time spent by a psychologist in therapeutic interventions produced the best results of therapeutic adherence / symptom improvement.
Seventy seven subjects followed the online self-help program for 8 weeks; 27 subjects had the support of a therapist via phone when they required it, 25 subjects had the support of a therapist weekly and 25 subjects were in the waiting list as a control group.
Detailed description
The aim of this study was to compare two ways of administrating the complementary psychological support (scheduled vs. non-scheduled) in an online self-help program for panic disorder. In order to do so, the investigators studied: a) If there were differences in the intensity and frequency of the symptoms of panic disorder. b) If there were differences in the therapeutic adherence between the subjects receiving both kinds of complementary support. c) If the more time spent by a psychologist in therapeutic interventions produced the best results of therapeutic adherence / symptom improvement.
Treatment program
Internet-based self-help program for anxiety disorders "FREE OF ANXIETY" was developed, based on cognitive behavioral therapy. The program is presented as an interactive course, which is divided into eight weekly modules.A number of therapeutic components are used: psychological education (modules 1-8), behavioral analysis (safety and avoidance behavior) (module 2), in vivo and interoceptive exposure (modules 2-8), relaxation training and diaphragmatic breathing (modules 1-4), cognitive restructuring (modules 4-5), mindfulness (Module 6) communication training (module 7), problem solving Module 8). The program also includes a messaging system between therapists and subjects.
Participants and Procedure
The participants were recruited using a google banner linked to searches about anxiety disorders. The individuals were redirected to a Web page which contained information about anxiety disorders and the aims of the study. Suicide risk (score of 3 in the 15th item of the Web Screening Questionnaire) was established as an exclusion criterion. The study was approved by the ethics committee of the Autonomous University of Barcelona.
Applicants completed the informed consent, the demographic questionnaire and a screening questionnaire online. One week later a psychologist who had been trained to apply the MINI International Neuropsychiatric Interview (Sheehan, Lecrubier, Harnett-Sheehan, Janavs,Weiller, Bonora, et al., 1997) assessed the presence of a current psychiatric diagnosis. Participants with Panic Disorder completed a battery of self-reported measures in order to assess panic disorder, anxiety, and depression symptoms.
After clinical evaluation, the participants were divided into three groups by a true random-number service.
The data collected were anonymized and coded
Seventy seven subjects followed the online self-help program for 8 weeks; 27 subjects had the support of a therapist via phone when they required it, 25 subjects had the support of a therapist weekly and 25 subjects were in the waiting list as a control group.
Participants completed self-reported measures at the end of the treatment, and six months later.
Statistical analyses
The investigators studied differences between participants with and without Panic Disorder regarding their gender and age, using Chi-square test and Student t-test.
The participants' pretreatment and posttreatment measures were analyzed with analysis of variance (ANOVA) with repeated measures. These were followed by t tests with Bonferroni-corrected p values. Effect sizes were calculated both within and between groups, and all calculations were based on the pooled standard deviation, Cohen's d.
All analyses were conducted using SPSS version 22 for Windows.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-scheduled support | Active comparator | Behavioral: Non-scheduled supportParticipants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it. |
| Scheduled support | Experimental | Behavioral: Scheduled supportParticipants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly. |
| Waiting list | No intervention | –Participants in a waiting list. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Meet Diagnostic Statistical Manual criteria for panic disorder.
- Have suffered from panic disorder at least one year.
- Suffer from panic disorder as primary pathology.
- If the participant was taking medication for panic disorder / agoraphobia, the dose should be stable three months before the start of the program.
Key exclusion criteria (4 listed)
- Obtain a score of 26 or more on the Beck Depression Inventory II
- Suffer from another psychiatric illness that requires immediate attention.
- Risk of suicide, indicated by a score of 3 on the screening questionnaire.
- Being or having been in cognitive behavioral therapy .
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 |
|---|---|---|
| Scheduled supportParticipants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly. | Behavioural | Scheduled support |
| Non-scheduled supportParticipants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it. | Behavioural | Non-scheduled support |
Primary outcome
Change From Baseline Score in the Panic Disorder Severity Scale at 8 Weeks and 6 Months.
Time frame: Baseline, 8 weeks, 6 months.
Panic Disorder Severity Scale Self-Report (PDSS-SR). This 7-item scale assesses the severity of PD through questions about the frequency of panic attacks, associated distress, anticipatory anxiety, agoraphobic and interoceptive avoidance, and social and work impairment. Score range: 0-28. Scores up to 10 correspond with ''mild,'' those between 11 and 15 with ''moderate,'' and those at or above 16 with ''severe'' panic disorder.
Change From Baseline Score in the Anxiety Sensitivity Index-3 at 8 Weeks and 6 Months.
Time frame: Baseline, 8 weeks, 6 months.
This 18-item scale evaluates sensitivity to anxiety symptoms on 3 dimensions: physical, cognitive, and social.There are 3 subscales, physical, cognitive, and social. For both the subscales (which range from 0 to 24) and the total scale (which range from 0 to 72), higher scores correspond to greater anxiety sensitivity.
7 secondary outcomes
Change From Baseline Score in the Beck Anxiety Inventory at 8 Weeks and 6 Months.
Time frame: Baseline, 8 weeks, 6 months.
Change From Baseline Score in the Beck Depression Inventory at 8 Weeks and 6 Months.
Time frame: Baseline, 8 weeks, 6 months.
Change From Baseline Score in the Sheehan Disability Inventory (Work Subscale) at 8 Weeks and 6 Months.
Time frame: Baseline, 8 weeks, 6 months.
Change From Baseline Score in the Sheehan Disability Inventory (Social Life Subscale) at 8 Weeks and 6 Months.
Time frame: Baseline, 8 weeks, 6 months.
Change From Baseline Score in the Sheehan Disability Inventory (Family Subscale) at 8 Weeks and 6 Months.
Time frame: Baseline, 8 weeks, 6 months.
Change From Baseline Score in the Sheehan Disability Inventory (Stress Subscale) at 8 Weeks and 6 Months.
Time frame: Baseline, 8 weeks, 6 months.
Change From Baseline Score in the Sheehan Disability Inventory (Social Support Subscale) at 8 Weeks and 6 Months.
Time frame: Baseline, 8 weeks, 6 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Beatriz Molinuevo, PhD study director
Department of Psychiatry and Forensic Medicine, Institute of Neurosciences, School of Medicine, Universitat Autònoma de Barcelona, Spain
Questions about this trial
What is this clinical trial studying?
A study testing Scheduled support and Non-scheduled support in people with Panic Disorder, run by Universitat Autonoma de Barcelona.
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 4 inclusion and 4 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 7 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 7 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline Score in the Panic Disorder Severity Scale at 8 Weeks and 6 Months. (time frame: Baseline, 8 weeks, 6 months.). The study lists 2 primary outcomes in all. 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 7 Dec 2015; AzTrials last refreshed its copy on 30 Oct 2026.