Internet-based Exposure Therapy for Excessive Worry

Study Overview
=================
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

Official Title
-----------------
Internet-based Exposure Therapy for Excessive Worry: A Randomized Trial

Conditions
-----------------
Excessive Worry, Rumination

Intervention / Treatment
-----------------
* Behavioral: Internet-based cognitive-behavior therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-based cognitive-behavior therapy<br>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<br>* 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.<br>|
| No Intervention: Waitlist<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 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. | 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 |