Trial Outcomes & Findings for Internet-based Self-help Treatment for Panic Disorder: Two Ways of Complementary Psychological Support (NCT NCT02402322)

NCT ID: NCT02402322

Last Updated: 2015-12-07

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

77 participants

Primary outcome timeframe

Baseline, 8 weeks, 6 months.

Results posted on

2015-12-07

Participant Flow

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.

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).

Participant milestones

Participant milestones
Measure
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.
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.
Waiting List
Participants in a waiting list.
Pretreatment
STARTED
27
25
25
Pretreatment
Posttreatment Measures
24
24
24
Pretreatment
COMPLETED
24
24
24
Pretreatment
NOT COMPLETED
3
1
1
Follow-up
STARTED
24
24
24
Follow-up
COMPLETED
18
21
0
Follow-up
NOT COMPLETED
6
3
24

Reasons for withdrawal

Reasons for withdrawal
Measure
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.
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.
Waiting List
Participants in a waiting list.
Pretreatment
Withdrawal by Subject
3
1
1
Follow-up
Withdrawal by Subject
6
3
24

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Non-scheduled Support
n=27 Participants
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.
Scheduled Support
n=25 Participants
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.
Waiting List
n=25 Participants
Participants in a waiting list.
Total
n=77 Participants
Total of all reporting groups
Age, Continuous
39.4 years
STANDARD_DEVIATION 8.5 • n=5 Participants
38.2 years
STANDARD_DEVIATION 7.8 • n=7 Participants
44.6 years
STANDARD_DEVIATION 10.3 • n=5 Participants
40.7 years
STANDARD_DEVIATION 9.3 • n=4 Participants
Sex: Female, Male
Female
19 Participants
n=5 Participants
19 Participants
n=7 Participants
15 Participants
n=5 Participants
53 Participants
n=4 Participants
Sex: Female, Male
Male
8 Participants
n=5 Participants
6 Participants
n=7 Participants
10 Participants
n=5 Participants
24 Participants
n=4 Participants
Region of Enrollment
Spain
27 participants
n=5 Participants
25 participants
n=7 Participants
25 participants
n=5 Participants
77 participants
n=4 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Non-scheduled Support
n=24 Participants
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.
Scheduled Support
n=24 Participants
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.
Waiting List
n=24 Participants
Participants in a waiting list.
Change From Baseline Score in the Panic Disorder Severity Scale at 8 Weeks and 6 Months.
Base line
15.29 units on a scale (range= 0-28)
Standard Deviation 4.21
15.75 units on a scale (range= 0-28)
Standard Deviation 4.52
13.08 units on a scale (range= 0-28)
Standard Deviation 3.81
Change From Baseline Score in the Panic Disorder Severity Scale at 8 Weeks and 6 Months.
8 weeks
10.42 units on a scale (range= 0-28)
Standard Deviation 3.14
7.21 units on a scale (range= 0-28)
Standard Deviation 2.16
13.13 units on a scale (range= 0-28)
Standard Deviation 4.5
Change From Baseline Score in the Panic Disorder Severity Scale at 8 Weeks and 6 Months.
Six months
10.21 units on a scale (range= 0-28)
Standard Deviation 2.57
8.33 units on a scale (range= 0-28)
Standard Deviation 2.61
13.13 units on a scale (range= 0-28)
Standard Deviation 4.5

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Non-scheduled Support
n=24 Participants
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.
Scheduled Support
n=24 Participants
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.
Waiting List
n=24 Participants
Participants in a waiting list.
Change From Baseline Score in the Anxiety Sensitivity Index-3 at 8 Weeks and 6 Months.
Base line
31.04 units on a scale (range= 0-72)
Standard Deviation 10.13
29.00 units on a scale (range= 0-72)
Standard Deviation 9.7
26.83 units on a scale (range= 0-72)
Standard Deviation 11.56
Change From Baseline Score in the Anxiety Sensitivity Index-3 at 8 Weeks and 6 Months.
8 weeks
21.54 units on a scale (range= 0-72)
Standard Deviation 10.07
14.75 units on a scale (range= 0-72)
Standard Deviation 7.71
28.08 units on a scale (range= 0-72)
Standard Deviation 11.94
Change From Baseline Score in the Anxiety Sensitivity Index-3 at 8 Weeks and 6 Months.
6 months
22.17 units on a scale (range= 0-72)
Standard Deviation 9.86
16.13 units on a scale (range= 0-72)
Standard Deviation 9.82
28.08 units on a scale (range= 0-72)
Standard Deviation 11.94

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Non-scheduled Support
n=24 Participants
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.
Scheduled Support
n=24 Participants
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.
Waiting List
n=24 Participants
Participants in a waiting list.
Change From Baseline Score in the Beck Anxiety Inventory at 8 Weeks and 6 Months.
Base line
34.92 units on a scale (range= 0-63)
Standard Deviation 8.6
34.29 units on a scale (range= 0-63)
Standard Deviation 10.97
30.63 units on a scale (range= 0-63)
Standard Deviation 9.53
Change From Baseline Score in the Beck Anxiety Inventory at 8 Weeks and 6 Months.
8 weeks
24.04 units on a scale (range= 0-63)
Standard Deviation 8.84
16.50 units on a scale (range= 0-63)
Standard Deviation 8.99
31.71 units on a scale (range= 0-63)
Standard Deviation 10.26
Change From Baseline Score in the Beck Anxiety Inventory at 8 Weeks and 6 Months.
6 months
24.33 units on a scale (range= 0-63)
Standard Deviation 9.51
17.75 units on a scale (range= 0-63)
Standard Deviation 8.72
31.71 units on a scale (range= 0-63)
Standard Deviation 10.26

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Non-scheduled Support
n=24 Participants
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.
Scheduled Support
n=24 Participants
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.
Waiting List
n=24 Participants
Participants in a waiting list.
Change From Baseline Score in the Beck Depression Inventory at 8 Weeks and 6 Months.
Base line
18.00 units on a scale (range= 0-63)
Standard Deviation 5.26
19.46 units on a scale (range= 0-63)
Standard Deviation 5.11
19.75 units on a scale (range= 0-63)
Standard Deviation 4.77
Change From Baseline Score in the Beck Depression Inventory at 8 Weeks and 6 Months.
8 weeks
11.92 units on a scale (range= 0-63)
Standard Deviation 6.02
10.71 units on a scale (range= 0-63)
Standard Deviation 5.56
19.58 units on a scale (range= 0-63)
Standard Deviation 6.71
Change From Baseline Score in the Beck Depression Inventory at 8 Weeks and 6 Months.
6 months
11.63 units on a scale (range= 0-63)
Standard Deviation 5.33
10.21 units on a scale (range= 0-63)
Standard Deviation 4.79
19.58 units on a scale (range= 0-63)
Standard Deviation 6.71

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Non-scheduled Support
n=24 Participants
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.
Scheduled Support
n=24 Participants
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.
Waiting List
n=24 Participants
Participants in a waiting list.
Change From Baseline Score in the Sheehan Disability Inventory (Work Subscale) at 8 Weeks and 6 Months.
8 weeks
4.42 units on a scale (range= 0-10)
Standard Deviation 2.55
2.96 units on a scale (range= 0-10)
Standard Deviation 2.42
5.79 units on a scale (range= 0-10)
Standard Deviation 3.09
Change From Baseline Score in the Sheehan Disability Inventory (Work Subscale) at 8 Weeks and 6 Months.
6 months
4.21 units on a scale (range= 0-10)
Standard Deviation 2.12
3.08 units on a scale (range= 0-10)
Standard Deviation 2.33
5.79 units on a scale (range= 0-10)
Standard Deviation 3.09
Change From Baseline Score in the Sheehan Disability Inventory (Work Subscale) at 8 Weeks and 6 Months.
Base line
6.33 units on a scale (range= 0-10)
Standard Deviation 2.53
5.88 units on a scale (range= 0-10)
Standard Deviation 2.61
5.67 units on a scale (range= 0-10)
Standard Deviation 3.29

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Non-scheduled Support
n=24 Participants
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.
Scheduled Support
n=24 Participants
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.
Waiting List
n=24 Participants
Participants in a waiting list.
Change From Baseline Score in the Sheehan Disability Inventory (Social Life Subscale) at 8 Weeks and 6 Months.
Base line
6.25 units on a scale (range= 0-10)
Standard Deviation 2.36
6.83 units on a scale (range= 0-10)
Standard Deviation 2.27
5.46 units on a scale (range= 0-10)
Standard Deviation 3.0
Change From Baseline Score in the Sheehan Disability Inventory (Social Life Subscale) at 8 Weeks and 6 Months.
8 weeks
4.54 units on a scale (range= 0-10)
Standard Deviation 2.37
3.75 units on a scale (range= 0-10)
Standard Deviation 2.48
5.46 units on a scale (range= 0-10)
Standard Deviation 3.06
Change From Baseline Score in the Sheehan Disability Inventory (Social Life Subscale) at 8 Weeks and 6 Months.
6 months
4.33 units on a scale (range= 0-10)
Standard Deviation 2.37
3.21 units on a scale (range= 0-10)
Standard Deviation 2.16
5.46 units on a scale (range= 0-10)
Standard Deviation 3.06

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Non-scheduled Support
n=24 Participants
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.
Scheduled Support
n=24 Participants
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.
Waiting List
n=24 Participants
Participants in a waiting list.
Change From Baseline Score in the Sheehan Disability Inventory (Family Subscale) at 8 Weeks and 6 Months.
Base line
4.96 units on a scale (range= 0-10)
Standard Deviation 2.75
4.88 units on a scale (range= 0-10)
Standard Deviation 2.55
4.58 units on a scale (range= 0-10)
Standard Deviation 2.99
Change From Baseline Score in the Sheehan Disability Inventory (Family Subscale) at 8 Weeks and 6 Months.
8 weeks
3.58 units on a scale (range= 0-10)
Standard Deviation 2.33
2.88 units on a scale (range= 0-10)
Standard Deviation 2.47
5.21 units on a scale (range= 0-10)
Standard Deviation 3.12
Change From Baseline Score in the Sheehan Disability Inventory (Family Subscale) at 8 Weeks and 6 Months.
6 months
3.46 units on a scale (range= 0-10)
Standard Deviation 2.51
2.54 units on a scale (range= 0-10)
Standard Deviation 2.57
5.21 units on a scale (range= 0-10)
Standard Deviation 3.12

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Non-scheduled Support
n=24 Participants
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.
Scheduled Support
n=24 Participants
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.
Waiting List
n=24 Participants
Participants in a waiting list.
Change From Baseline Score in the Sheehan Disability Inventory (Stress Subscale) at 8 Weeks and 6 Months.
Base line
7.42 units on a scale (range= 0-10)
Standard Deviation 1.61
7.38 units on a scale (range= 0-10)
Standard Deviation 2.37
7.17 units on a scale (range= 0-10)
Standard Deviation 2.29
Change From Baseline Score in the Sheehan Disability Inventory (Stress Subscale) at 8 Weeks and 6 Months.
8 weeks
5.04 units on a scale (range= 0-10)
Standard Deviation 2.07
4.63 units on a scale (range= 0-10)
Standard Deviation 2.88
6.96 units on a scale (range= 0-10)
Standard Deviation 2.86
Change From Baseline Score in the Sheehan Disability Inventory (Stress Subscale) at 8 Weeks and 6 Months.
6 months
4.92 units on a scale (range= 0-10)
Standard Deviation 2.10
3.79 units on a scale (range= 0-10)
Standard Deviation 2.50
6.96 units on a scale (range= 0-10)
Standard Deviation 2.86

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Non-scheduled Support
n=24 Participants
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.
Scheduled Support
n=24 Participants
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.
Waiting List
n=24 Participants
Participants in a waiting list.
Change From Baseline Score in the Sheehan Disability Inventory (Social Support Subscale) at 8 Weeks and 6 Months.
Base line
58.75 units on a scale (range= 0-100)
Standard Deviation 31.80
60.00 units on a scale (range= 0-100)
Standard Deviation 30.78
49.58 units on a scale (range= 0-100)
Standard Deviation 35.19
Change From Baseline Score in the Sheehan Disability Inventory (Social Support Subscale) at 8 Weeks and 6 Months.
8 weeks
62.92 units on a scale (range= 0-100)
Standard Deviation 28.51
72.50 units on a scale (range= 0-100)
Standard Deviation 24.53
62.92 units on a scale (range= 0-100)
Standard Deviation 27.73
Change From Baseline Score in the Sheehan Disability Inventory (Social Support Subscale) at 8 Weeks and 6 Months.
6 months
68.33 units on a scale (range= 0-100)
Standard Deviation 20.57
70.00 units on a scale (range= 0-100)
Standard Deviation 22.26
62.92 units on a scale (range= 0-100)
Standard Deviation 27.73

Adverse Events

Non-scheduled Support

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Scheduled Support

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Waiting List

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Pablo Oromendia

Universitat Autonoma de Barcelona

Phone: +34 665175467

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place