Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2026-02-20 @ 6:01 PM
Study NCT ID:
NCT02638792
Status:
COMPLETED
Last Update Posted:
2017-11-28
First Post:
2015-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Internet-Based Exposure Therapy Vs. Stress-Management Training for Worry
Sponsor:
Karolinska Institutet
Organization:
Study Overview
Official Title:
Internet-Based Exposure Therapy Vs. Stress-Management Training for Worry: A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to examine if an internet-based exposure therapy is more effective in reducing excessive worry amongst patients who suffer from this problem than is internet-based stress management training.
Detailed Description:
Trial Objectives: Primary objective is to investigate whether an Internet-based exposure therapy can reduce the degree of excessive worry to a significantly greater extent than Internet-based stress-management training. The secondary objective is to a) investigate the cost-effectiveness of this treatment b) to study if any variables could moderate/mediate the treatment outcome, c) and to investigate the importance of sudden gains for the treatment outcome
Trial Design: Randomized controlled trial with an active control and a waitlist control, who also will recieve treatment after the first group has finished.
Duration: Ten weeks
Primary Endpoint:
Difference in worry symptoms between the treatment groups at week 10. Long term follow-up is also investigated (baseline to 4-months after treatment completion and baseline to 12-months after treatment completion).
Efficacy Parameters: Penn State Worry Questionnaire (PSWQ)
Safety Parameters: Adverse Events is assessed via the internet.
Description of Trial Subjects: Patients \> 18 years old with a PSWQ score more than 56 points
Number of Subjects: 300
Trial Design: Randomized controlled trial with an active control and a waitlist control, who also will recieve treatment after the first group has finished.
Duration: Ten weeks
Primary Endpoint:
Difference in worry symptoms between the treatment groups at week 10. Long term follow-up is also investigated (baseline to 4-months after treatment completion and baseline to 12-months after treatment completion).
Efficacy Parameters: Penn State Worry Questionnaire (PSWQ)
Safety Parameters: Adverse Events is assessed via the internet.
Description of Trial Subjects: Patients \> 18 years old with a PSWQ score more than 56 points
Number of Subjects: 300
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: