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

NCT02402322 | Completed Results

• 1 other identifier: PTCCAP
• Study Type: interventional
• Target: 77
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Panic Disorder

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline, 8 weeks, 6 months.

Secondary Outcomes (7)

• 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 Beck Depression Inventory 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 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 (Family Subscale) at 8 Weeks and 6 Months.

  Baseline, 8 weeks, 6 months.

Study Arms (3)

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.

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.

Behavioral: Scheduled support

Waiting list

NO INTERVENTION

Participants in a waiting list.

Interventions

Scheduled support BEHAVIORAL

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.

Scheduled support

Non-scheduled support BEHAVIORAL

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.

Non-scheduled support

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Universitat Autonoma de Barcelona: lead

MeSH Terms

Conditions

Panic Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Pablo Oromendia
• Organization: Universitat Autonoma de Barcelona

p.oromendia@gmail.com

+34 665175467

Study Officials

• Beatriz Molinuevo, PhD

  Department of Psychiatry and Forensic Medicine, Institute of Neurosciences, School of Medicine, Universitat Autònoma de Barcelona, Spain

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Study Record Dates

• First Submitted: March 20, 2015
• First Posted: March 30, 2015
• Study Start: August 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 7, 2015
• Results First Posted: December 7, 2015

Record last verified: 2015-10