Internet-based Exposure Therapy for Excessive Worry

Karolinska Institute

Status: Completed

Conditions: Excessive Worry; Rumination

Treatments: Behavioral: Internet-based cognitive-behavior therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02331537

2014-1944-31-5

Details and patient eligibility

About

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.

Full 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

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Internet-based cognitive-behavior therapy

Experimental group

Description:

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.

Treatment:

Behavioral: Internet-based cognitive-behavior therapy

Waitlist

No Intervention group

Description:

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.