Karolinska Institutet
Stockholm, Stockholm County, 17177, Sweden
NCT Number: NCT02331537
The purpose of this study is to examine if an internet-based exposure therapy is effective in reducing excessive worry amongst patients who suffer from this problem.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Stockholm, Stockholm County, 17177, Sweden
Trial Objectives: Primary objective is to investigate whether an Internet-based exposure therapy can effectively reduce the degree of excessive worry. The secondary objective is to a) investigate whether imagery based exposure is more effective than verbal exposure. b) investigate the cost-effectiveness of this treatment and c) to study if any variables could moderate/mediate the treatment outcome, such as metacognitions, degree of rumination or degree of depression.
Trial Design: Randomized controlled trial with waitlist control, who also will recieve treatment after the first group has finished.
Duration: Ten weeks
Primary Endpoint: Change in worry symptoms from baseline to 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 weekly via the internet.
Description of Trial Subjects: Patients > 18 years old with a PSWQ score more than 56 points
Number of Subjects: 140
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Internet-based cognitive-behavior therapy on a safe internet platform. Treatment is divided into seven modules, each containing homework assignments . The participants will be assigned a therapist that they can contact through a message system in the platform and expect answer within 24 hours.
Time frame: Week 0, Week 10, Long term follow-up at 4-, and 12-months after treatment has ended
Change in worry from baseline to Week 10, and at 4- and 12 months after treatment has ended.
Time frame: Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended
Change in metacognitions from baseline to Week 10 and at 4- and 12 months after treatment has ended.
Time frame: Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended
Change in depression from baseline to Week 10 and at 4- and 12 months after treatment has ended.
Time frame: Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended
Change in general health from baseline to Week 10 and at 4- and 12 months after treatment has ended.
Time frame: Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended
Change in anxiety and depression from baseline to Week 10 and at 4- and 12 months after treatment has ended.
Time frame: Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended
Change in Spontaneous Use of Imagery from baseline to Week 10 and at 4- and 12 months after treatment has ended.
Time frame: Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended
Change in cognitive avoidance from baseline to Week 10 and at 4- and 12 months after treatment has ended.
Time frame: Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended
Change in economic costs from baseline to Week 10 and at 4- and 12 months after treatment has ended.
Time frame: Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended
Change in tolerance of uncertainty from baseline to Week 10 and at 4- and 12 months after treatment has ended.
Karolinska Institutet
Other
Internet-based Exposure Therapy for Excessive Worry: A Randomized Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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