Internet-based Exposure Therapy for Excessive Worry

Rumination Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02331537
• Other study ID #: 2014-1944-31-5
• Status: Completed
• Phase: N/A
• First received: January 1, 2015
• Last updated: August 31, 2015
• Start date: January 2015
• Est. completion date: June 2015

Study information

• Verified date: August 2015
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Excessive Worry
• Rumination

Intervention

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.

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No