An interventional study of Internet-based cognitive-behavior therapy in Excessive Worry and Rumination, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-09-01.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
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.
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
72 studies on the registry are indexed under Rumination Syndrome; 22 are open to participants now.
This study's planned enrollment of 140 is above the median of 62 across 63 interventional studies indexed under Rumination Syndrome.
Browse Rumination Syndrome studies →Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.
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Exclusion Criteria:
The experimental group will go through active internet-based treatment. The treatment is 10 weeks long and is based on the principles of exposure i.e. the participant is instructed to stay with the frightening thought until it is no longer associated with anxiety.
Behavioral: Internet-based cognitive-behavior therapy
Waitlist control that will get the internet-based treatment when the first group has finished (i.e. Week 10). There are no active treatment for these participants at all.
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.
Penn State Worry Questionnaire (PSWQ)
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
Meta Cognitions Questionnaire (MCQ-30)
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
Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S)
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
Euroqol (EQ-5D)
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
Hospital anxiety and depression scale (HADS)
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
Spontaneous Use of Imagery Scale (SUIS)
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
Cognitive Avoidance Questionnaire (CAQ)
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
Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)
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
Intolerance of Uncertainty Scale (IUS)
Change in tolerance of uncertainty 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
This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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Karolinska Institutet