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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Internet-based cognitive-behavior therapy | Experimental | 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. |
|
| Waitlist | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internet-based cognitive-behavior therapy | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Penn State Worry Questionnaire (PSWQ) | Change in worry from baseline to Week 10, and at 4- and 12 months after treatment has ended. | Week 0, Week 10, Long term follow-up at 4-, and 12-months after treatment has ended |
| Measure | Description | Time Frame |
|---|---|---|
| Meta Cognitions Questionnaire (MCQ-30) | Change in metacognitions from baseline to Week 10 and at 4- and 12 months after treatment has ended. | Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended |
| Montgomery Ã…sberg Depression Rating Scale - Self-report (MADRS-S) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erik M Andersson, PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska Institutet | Stockholm | Stockholm County | 17177 | Sweden |
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| ID | Term |
|---|---|
| D000079562 | Rumination Syndrome |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
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Change in depression from baseline to Week 10 and at 4- and 12 months after treatment has ended. |
| 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. | 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. | 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. | 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. | 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. | 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. | Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended |