Excessive Worry, Rumination
Conditions
Brief summary
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.
Detailed description
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
Interventions
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.
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Outpatients * ≥ 18 years * Situated in Sweden * Informed consent * Penn State Worry Questionnaire score more than 56 points
Exclusion criteria
* Substance dependence during the last six months * Post traumatic stress disorder, bipolar disorder or psychosis * Symptoms better explained by axis 2 diagnosis (e.g. autism or borderline personality disorder) * MADRS-S score above 25 points * Psychotropic medication changes within two months prior to treatment that could affect target symptoms. * Received exposure based Cognitive behavior therapy (CBT) for pathological worry the last 2 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Penn State Worry Questionnaire (PSWQ) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Meta Cognitions Questionnaire (MCQ-30) | 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. |
| Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S) | 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. |
| Euroqol (EQ-5D) | 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. |
| Hospital anxiety and depression scale (HADS) | 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. |
| Spontaneous Use of Imagery Scale (SUIS) | 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. |
| Cognitive Avoidance Questionnaire (CAQ) | 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. |
| Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P) | 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. |
| Intolerance of Uncertainty Scale (IUS) | 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. |
Countries
Sweden
Outcome results
None listed