NCT02638792

Internet-Based Exposure Therapy Vs. Stress-Management Training for Worry

Internet-Based Exposure Therapy Vs. Stress-Management Training for Worry: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 311 (actual)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Excessive Worry

Interventions

Type	Name	Description
BEHAVIORAL	Internet-based exposure therapy (I-ET)	The internet-based exposure therapy (I-ET) group receives a ten-week Internet-based CBT treatment, which is an extended version of the self-help book "Sluta älta och grubbla med kognitiv beteendeterapi" (How to quit worrying and ruminating with Cognitive behavior therapy) by licensed psychologist Olle Wadström (2007). The main focus of the book is to expose to the frightening word/image and refrain from using neutralizing thoughts. This is supposed to lead to the extinction of upsetting words/images.
BEHAVIORAL	Internet-based stress management therapy	The I-SMT group receives a ten-week Internet-based CBT treatment focused on stress and how to manage stressful situations. This protocol is based on current evidence based recommendations for worry and has shown to be effective when delivered via the internet for irritable bowel syndrome and hypochondric worries.

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2015-12-23
• Last updated: 2017-11-28

Locations

1 site across 1 country: Sweden