Internet-based Exposure Therapy for Excessive Worry

Not Applicable

Completed

• Conditions: Rumination; Excessive Worry
• Interventions: Behavioral: Internet-based cognitive-behavior therapy

• Registration Number: NCT02331537
• Lead Sponsor: Karolinska Institutet

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

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-01
• Study First Submitted QC: 2015-01-02
• Study First Posted: 2015-01-06
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-31
• Last Update Posted: 2015-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Outpatients
• ≥ 18 years
• Situated in Sweden
• Informed consent
• Penn State Worry Questionnaire score more than 56 points

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Internet-based cognitive-behavior therapy	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.

Primary Outcome Measures

Name	Time	Method
Penn State Worry Questionnaire (PSWQ)	Week 0, Week 10, Long term follow-up at 4-, and 12-months after treatment has ended	Change in worry from baseline to Week 10, and at 4- and 12 months after treatment has ended.

Secondary Outcome Measures

Name	Time	Method
Spontaneous Use of Imagery Scale (SUIS)	Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended	Change in Spontaneous Use of Imagery from baseline to Week 10 and at 4- and 12 months after treatment has ended.
Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S)	Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended	Change in depression from baseline to Week 10 and at 4- and 12 months after treatment has ended.
Cognitive Avoidance Questionnaire (CAQ)	Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended	Change in cognitive avoidance from baseline to Week 10 and at 4- and 12 months after treatment has ended.
Meta Cognitions Questionnaire (MCQ-30)	Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended	Change in metacognitions from baseline to Week 10 and at 4- and 12 months after treatment has ended.
Euroqol (EQ-5D)	Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended	Change in general health from baseline to Week 10 and at 4- and 12 months after treatment has ended.
Hospital anxiety and depression scale (HADS)	Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended	Change in anxiety and depression from baseline to Week 10 and at 4- and 12 months after treatment has ended.
Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)	Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended	Change in economic costs from baseline to Week 10 and at 4- and 12 months after treatment has ended.
Intolerance of Uncertainty Scale (IUS)	Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended	Change in tolerance of uncertainty from baseline to Week 10 and at 4- and 12 months after treatment has ended.

Trial Locations

Locations (1)

Karolinska Institutet; 🇸🇪 Stockholm, Sweden