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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
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.
Karolinska Institutet
Stockholm, Stockholm County, Sweden
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
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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