Internet-Based Exposure Therapy Vs. Stress-Management Training for Worry

Karolinska Institute

Status: Completed

Conditions: Excessive Worry

Treatments: Behavioral: Internet-based stress management therapy; Behavioral: Internet-based exposure therapy (I-ET)

Study type: Interventional

Funder types: Other

Identifiers

NCT02638792

REPN 2015/1698-31/1

Details and patient eligibility

About

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.

Full 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

Enrollment: 311 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Outpatients
• ≥ 18 years
• Situated in Sweden
• Informed consent
• PSWQ 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 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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311 participants in 3 patient groups

Internet-based exposure therapy

Experimental group

Description:

The internet-based exposure therapy (I-ET) group receives a ten-week Internet-based CBT treatment, which is an extended version of the self-help book "Sluta älta och grubbla med kognitiv beteendeterapi" (How to quit worrying and ruminating with Cognitive behavior therapy) by licensed psychologist Olle Wadström (2007). The main focus of the book is to expose to the frightening word/image and refrain from using neutralizing thoughts. This is supposed to lead to the extinction of upsetting words/images.

Treatment:

Behavioral: Internet-based exposure therapy (I-ET)

Internet-based stress management therapy

Active Comparator group

Description:

The I-SMT group receives a ten-week Internet-based CBT treatment focused on stress and how to manage stressful situations. This protocol is based on current evidence based recommendations for worry and has shown to be effective when delivered via the internet for irritable bowel syndrome and hypochondric worries.

Treatment:

Behavioral: Internet-based stress management therapy

Waitlist

No Intervention group

Description:

When the active treatment groups have finished treatment (W11), the WL group will be able to start active treatment and be assessed at post-treatment, and 4, 12 months later using the same questionnaires as the treatment group. The participants will be able to choose which treatment they receive i.e. no randomization.