Internet-based Exposure Therapy for Excessive Worry

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

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.

Study Overview

• Status: Completed
• Conditions: Rumination; Excessive Worry
• Intervention / Treatment: Behavioral: Internet-based cognitive-behavior therapy

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

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 17177
    • Karolinska Institutet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Internet-based cognitive-behavior therapy; 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; 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.
No Intervention: Waitlist; 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

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Erik M Andersson, PhD, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: January 1, 2015
• First Submitted That Met QC Criteria: January 2, 2015
• First Posted (Estimate): January 6, 2015

Study Record Updates

• Last Update Posted (Estimate): September 1, 2015
• Last Update Submitted That Met QC Criteria: August 31, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Digestive System Diseases; Feeding and Eating Disorders; Gastrointestinal Diseases; Rumination Syndrome
• Other Study ID Numbers: 2014-1944-31-5