Clinical trial NCT02402322: Internet-based Self-help Treatment for Panic Disorder: Two Ways of Complementary Psychological Support
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Panic Disorder
Lead sponsor: Universitat Autonoma de Barcelona
Sponsor class: OTHER
First posted: 2015-03-30
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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 .

Primary outcomes:
measure: Change From Baseline Score in the Panic Disorder Severity Scale at 8 Weeks and 6 Months.
timeFrame: Baseline, 8 weeks, 6 months.
measure: Change From Baseline Score in the Anxiety Sensitivity Index-3 at 8 Weeks and 6 Months.
timeFrame: Baseline, 8 weeks, 6 months.
Secondary outcomes:
measure: Change From Baseline Score in the Beck Anxiety Inventory at 8 Weeks and 6 Months.
timeFrame: Baseline, 8 weeks, 6 months.
measure: Change From Baseline Score in the Beck Depression Inventory at 8 Weeks and 6 Months.
timeFrame: Baseline, 8 weeks, 6 months.
measure: Change From Baseline Score in the Sheehan Disability Inventory (Work Subscale) at 8 Weeks and 6 Months.
timeFrame: Baseline, 8 weeks, 6 months.
measure: Change From Baseline Score in the Sheehan Disability Inventory (Social Life Subscale) at 8 Weeks and 6 Months.
timeFrame: Baseline, 8 weeks, 6 months.
measure: Change From Baseline Score in the Sheehan Disability Inventory (Family Subscale) at 8 Weeks and 6 Months.
timeFrame: Baseline, 8 weeks, 6 months.
measure: Change From Baseline Score in the Sheehan Disability Inventory (Stress Subscale) at 8 Weeks and 6 Months.
timeFrame: Baseline, 8 weeks, 6 months.
measure: Change From Baseline Score in the Sheehan Disability Inventory (Social Support Subscale) at 8 Weeks and 6 Months.
timeFrame: Baseline, 8 weeks, 6 months.
Other outcomes:
Locations:
Study officials:
affiliation: Department of Psychiatry and Forensic Medicine, Institute of Neurosciences, School of Medicine, Universitat Autònoma de Barcelona, Spain
name: Beatriz Molinuevo, PhD
role: STUDY_DIRECTOR
References: