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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 77
- Primary Endpoint
- Change From Baseline Score in the Panic Disorder Severity Scale at 8 Weeks and 6 Months.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 .
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Change From Baseline Score in the Beck Depression Inventory at 8 Weeks and 6 Months.(Baseline, 8 weeks, 6 months.)
- Change From Baseline Score in the Sheehan Disability Inventory (Social Life Subscale) at 8 Weeks and 6 Months.(Baseline, 8 weeks, 6 months.)
- Change From Baseline Score in the Sheehan Disability Inventory (Work Subscale) at 8 Weeks and 6 Months.(Baseline, 8 weeks, 6 months.)
- Change From Baseline Score in the Beck Anxiety Inventory at 8 Weeks and 6 Months.(Baseline, 8 weeks, 6 months.)
- Change From Baseline Score in the Sheehan Disability Inventory (Social Support Subscale) at 8 Weeks and 6 Months.(Baseline, 8 weeks, 6 months.)
- Change From Baseline Score in the Sheehan Disability Inventory (Family Subscale) at 8 Weeks and 6 Months.(Baseline, 8 weeks, 6 months.)
- Change From Baseline Score in the Sheehan Disability Inventory (Stress Subscale) at 8 Weeks and 6 Months.(Baseline, 8 weeks, 6 months.)
Investigators
Pablo Oromendia
PhD Candidate
Universitat Autonoma de Barcelona