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

Excessive Worry Clinical Trial

Official title:

Internet-Based Exposure Therapy Vs. Stress-Management Training for Worry: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02638792
• Other study ID #: REPN 2015/1698-31/1
• Status: Completed
• Phase: N/A
• First received: December 19, 2015
• Last updated: November 26, 2017
• Start date: December 2015
• Est. completion date: May 2016

Study information

• Verified date: November 2017
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 311
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Excessive Worry

Intervention

Behavioral:
• Internet-based exposure therapy (I-ET)
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.
• Internet-based stress management therapy
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.

Locations

Country	Name	City	State
Sweden	Karolinska Intitutet	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment credibility scale	Investigate if both conditions have equal credibility in order to rule out placebo	Week 2
Other	Working alliance scale	Investigate if both conditions have equal working alliance in order to rule out non-specific factors	Week 5
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 (weekly measurements), at 4 months follow up, 12 months follow up.
Secondary	Montgomery Åsberg Depression Rating Scale (MADRS-S)	Change in depression from baseline to Week 10 and at 4- and 12 months after treatment has ended.	Week 0, Week 10, 4 and 12 months follow-up
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, 4 and 12 months follow-up
Secondary	Cognitive Avoidance Questionnaire (CAQ)	Change in cognitive avoidance from baseline to Week 10, at 4- and 12 after treatment has ended, and weekly during treatment	Week 0, Week 10, at 4 and 12 months follow up and weekly during treatment
Secondary	Intolerance of uncertainty scale	Change in thought control efforts from baseline to Week 10, at 4- and 12 months after treatment has ended, and weekly during treatment	Week 0, Week 10, at 4 and 12 months follow-up, and weekly during treatment
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, 4 and 12 months follow-up
Secondary	Brunnsviken Quality of Life Questionnaire (BBQ)	Change in self-perceived quality of life from baseline to week 10 and at 4 and 12 months after treatment has ended	Week 0, Week 10, 4 and 12 months follow-up
Secondary	Thought supression subscale of the Cognitive Avoidance Questionnaire (CAQ)	Weekly change in thought supression from baseline to Week 10	Week 0 - Week 10 (weekly measurements)
Secondary	The self-regulation subscale of the Multidimensional Assessment of Interoceptive Awareness	Weekly change in self-regulation from baseline to Week 10	Week 0 - Week 10 (weekly measurements)
Secondary	Patient Health Questionnaire-2	Weekly change in depressive symptom from baseline to Week 10	Week 0 - Week 10 (weekly measurements)
Secondary	Adverse Events	Number of adverse events from baseline to Week 10 and at 4 and 12 months	Week 3, week 8, week 10, 4 and 12 months follow-up