Internet-Based Exposure Therapy Vs. Stress-Management Training for Worry
- Conditions
- Excessive Worry
- Registration Number
- NCT02638792
- Lead Sponsor
- Karolinska Institutet
- Brief Summary
The purpose of this study is to examine if an internet-based exposure therapy is more effective in reducing excessive worry amongst patients who suffer from this problem than is internet-based stress management training.
- Detailed Description
Trial Objectives: Primary objective is to investigate whether an Internet-based exposure therapy can reduce the degree of excessive worry to a significantly greater extent than Internet-based stress-management training. The secondary objective is to a) investigate the cost-effectiveness of this treatment b) to study if any variables could moderate/mediate the treatment outcome, c) and to investigate the importance of sudden gains for the treatment outcome
Trial Design: Randomized controlled trial with an active control and a waitlist control, who also will recieve treatment after the first group has finished.
Duration: Ten weeks
Primary Endpoint:
Difference in worry symptoms between the treatment groups at 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 via the internet.
Description of Trial Subjects: Patients \> 18 years old with a PSWQ score more than 56 points
Number of Subjects: 300
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 311
- Outpatients
- ≥ 18 years
- Situated in Sweden
- Informed consent
- PSWQ score more than 56 points
- 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 CBT for pathological worry the last 2 years.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Penn State Worry Questionnaire (PSWQ) week 0, week 10 (weekly measurements), at 4 months follow up, 12 months follow up. Change in worry from baseline to Week 10 and at 4- and 12 months after treatment has ended.
- Secondary Outcome Measures
Name Time Method Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P) Week 0, Week 10, 4 and 12 months follow-up Change in economic costs from baseline to Week 10 and at 4- and 12 months after treatment has ended
Thought supression subscale of the Cognitive Avoidance Questionnaire (CAQ) Week 0 - Week 10 (weekly measurements) Weekly change in thought supression from baseline to Week 10
The self-regulation subscale of the Multidimensional Assessment of Interoceptive Awareness Week 0 - Week 10 (weekly measurements) Weekly change in self-regulation from baseline to Week 10
Euroqol, EQ-5D Week 0, Week 10, 4 and 12 months follow-up Change in general health from baseline to Week 10 and at 4- and 12 months after treatment has ended
Intolerance of uncertainty scale Week 0, Week 10, at 4 and 12 months follow-up, and weekly during treatment Change in thought control efforts from baseline to Week 10, at 4- and 12 months after treatment has ended, and weekly during treatment
Brunnsviken Quality of Life Questionnaire (BBQ) Week 0, Week 10, 4 and 12 months follow-up Change in self-perceived quality of life from baseline to week 10 and at 4 and 12 months after treatment has ended
Patient Health Questionnaire-2 Week 0 - Week 10 (weekly measurements) Weekly change in depressive symptom from baseline to Week 10
Adverse Events Week 3, week 8, week 10, 4 and 12 months follow-up Number of adverse events from baseline to Week 10 and at 4 and 12 months
Montgomery Åsberg Depression Rating Scale (MADRS-S) Week 0, Week 10, 4 and 12 months follow-up Change in depression from baseline to Week 10 and at 4- and 12 months after treatment has ended.
Cognitive Avoidance Questionnaire (CAQ) Week 0, Week 10, at 4 and 12 months follow up and weekly during treatment Change in cognitive avoidance from baseline to Week 10, at 4- and 12 after treatment has ended, and weekly during treatment
Trial Locations
- Locations (1)
Karolinska Intitutet
🇸🇪Stockholm, Sweden
Karolinska Intitutet🇸🇪Stockholm, Sweden