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

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

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.

Study Overview

• Status: Completed
• Conditions: Excessive Worry
• Intervention / Treatment: Behavioral: Internet-based exposure therapy (I-ET); Behavioral: Internet-based stress management therapy

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 311
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 17177
    • Karolinska Intitutet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Internet-based exposure therapy; 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.	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.
ACTIVE_COMPARATOR: 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.	Behavioral: 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.
NO_INTERVENTION: Waitlist; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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)
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)
Patient Health Questionnaire-2	Weekly change in depressive symptom from baseline to Week 10	Week 0 - Week 10 (weekly measurements)
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment credibility scale	Investigate if both conditions have equal credibility in order to rule out placebo	Week 2
Working alliance scale	Investigate if both conditions have equal working alliance in order to rule out non-specific factors	Week 5

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Erik M Andersson, PhD, Psych., Karolinska Institutet

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (ACTUAL): May 1, 2016
• Study Completion (ACTUAL): May 1, 2016

Study Registration Dates

• First Submitted: December 19, 2015
• First Submitted That Met QC Criteria: December 19, 2015
• First Posted (ESTIMATE): December 23, 2015

Study Record Updates

• Last Update Posted (ACTUAL): November 28, 2017
• Last Update Submitted That Met QC Criteria: November 26, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: REPN 2015/1698-31/1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO