Internet-based Self-help Treatment for Panic Disorder: Two Ways of Complementary Psychological Support

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)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02402322

Enrollment

Registered

2015-03-30

Start date

2013-08-31

Completion date

2014-11-30

Last updated

2015-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Panic Disorder

Brief summary

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.

Interventions

BEHAVIORALScheduled support

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.

BEHAVIORALNon-scheduled support

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 design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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 .

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline Score in the Panic Disorder Severity Scale at 8 Weeks and 6 Months.	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.	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

Measure	Time frame	Description
Change From Baseline Score in the Sheehan Disability Inventory (Social Life Subscale) at 8 Weeks and 6 Months.	Baseline, 8 weeks, 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.
Change From Baseline Score in the Sheehan Disability Inventory (Family Subscale) at 8 Weeks and 6 Months.	Baseline, 8 weeks, 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.
Change From Baseline Score in the Sheehan Disability Inventory (Stress Subscale) at 8 Weeks and 6 Months.	Baseline, 8 weeks, 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.
Change From Baseline Score in the Sheehan Disability Inventory (Social Support Subscale) at 8 Weeks and 6 Months.	Baseline, 8 weeks, 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.
Change From Baseline Score in the Beck Anxiety Inventory at 8 Weeks and 6 Months.	Baseline, 8 weeks, 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.
Change From Baseline Score in the Beck Depression Inventory at 8 Weeks and 6 Months.	Baseline, 8 weeks, 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.
Change From Baseline Score in the Sheehan Disability Inventory (Work Subscale) at 8 Weeks and 6 Months.	Baseline, 8 weeks, 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.

Participant flow

Recruitment details

Participants were recruited through advertisements on the Internet and were redirected to a website containing information about the study. Individuals interested in taking part in the study completed a screening questionnaire and provided demographic data. Participants were recruited between August, 2013 and February 2014.

Pre-assignment details

Individuals were evaluated thoroughly using the MINI International Neuropsychiatric Interview. One hundred and twenty-five individuals were assessed and 48 were excluded from the trial because they suffered from another disorder (n=34), their medication was not stable (n = 13), or they had received Cognitive Behavioral Therapy (n = 1).

Participants by arm

Arm	Count
Non-scheduled Support Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it. Non-scheduled support: 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.	27
Scheduled Support Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly. Scheduled support: 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.	25
Waiting List Participants in a waiting list.	25
Total	77

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Follow-up	Withdrawal by Subject	6	3	24
Pretreatment	Withdrawal by Subject	3	1	1

Baseline characteristics

Characteristic	Non-scheduled Support	Scheduled Support	Waiting List	Total
Age, Continuous	39.4 years STANDARD_DEVIATION 8.5	38.2 years STANDARD_DEVIATION 7.8	44.6 years STANDARD_DEVIATION 10.3	40.7 years STANDARD_DEVIATION 9.3
Region of Enrollment Spain	27 participants	25 participants	25 participants	77 participants
Sex: Female, Male Female	19 Participants	19 Participants	15 Participants	53 Participants
Sex: Female, Male Male	8 Participants	6 Participants	10 Participants	24 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	0 / 24	0 / 24	0 / 24
serious Total, serious adverse events	0 / 24	0 / 24	0 / 24

Outcome results

Primary

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.