Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02638792
Recruitment Status : Completed
First Posted : December 23, 2015
Last Update Posted : November 28, 2017
Sponsor:
Information provided by (Responsible Party):
Erik Andersson, Karolinska Institutet

Brief 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.

Condition or disease Intervention/treatment Phase
Excessive Worry Behavioral: Internet-based exposure therapy (I-ET) Behavioral: Internet-based stress management therapy Not Applicable

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 311 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Internet-Based Exposure Therapy Vs. Stress-Management Training for Worry: A Randomized Controlled Trial
Study Start Date : December 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

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.



Primary Outcome Measures :
  1. Penn State Worry Questionnaire (PSWQ) [ Time Frame: week 0, week 10 (weekly measurements), at 4 months follow up, 12 months follow up. ]
    Change in worry from baseline to Week 10 and at 4- and 12 months after treatment has ended.


Secondary Outcome Measures :
  1. Montgomery Åsberg Depression Rating Scale (MADRS-S) [ Time Frame: Week 0, Week 10, 4 and 12 months follow-up ]
    Change in depression from baseline to Week 10 and at 4- and 12 months after treatment has ended.

  2. Euroqol, EQ-5D [ Time Frame: Week 0, Week 10, 4 and 12 months follow-up ]
    Change in general health from baseline to Week 10 and at 4- and 12 months after treatment has ended

  3. Cognitive Avoidance Questionnaire (CAQ) [ Time Frame: Week 0, Week 10, at 4 and 12 months follow up and weekly during treatment ]
    Change in cognitive avoidance from baseline to Week 10, at 4- and 12 after treatment has ended, and weekly during treatment

  4. Intolerance of uncertainty scale [ Time Frame: Week 0, Week 10, at 4 and 12 months follow-up, and weekly during treatment ]
    Change in thought control efforts from baseline to Week 10, at 4- and 12 months after treatment has ended, and weekly during treatment

  5. Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P) [ Time Frame: Week 0, Week 10, 4 and 12 months follow-up ]
    Change in economic costs from baseline to Week 10 and at 4- and 12 months after treatment has ended

  6. Brunnsviken Quality of Life Questionnaire (BBQ) [ Time Frame: Week 0, Week 10, 4 and 12 months follow-up ]
    Change in self-perceived quality of life from baseline to week 10 and at 4 and 12 months after treatment has ended

  7. Thought supression subscale of the Cognitive Avoidance Questionnaire (CAQ) [ Time Frame: Week 0 - Week 10 (weekly measurements) ]
    Weekly change in thought supression from baseline to Week 10

  8. The self-regulation subscale of the Multidimensional Assessment of Interoceptive Awareness [ Time Frame: Week 0 - Week 10 (weekly measurements) ]
    Weekly change in self-regulation from baseline to Week 10

  9. Patient Health Questionnaire-2 [ Time Frame: Week 0 - Week 10 (weekly measurements) ]
    Weekly change in depressive symptom from baseline to Week 10

  10. Adverse Events [ Time Frame: Week 3, week 8, week 10, 4 and 12 months follow-up ]
    Number of adverse events from baseline to Week 10 and at 4 and 12 months


Other Outcome Measures:
  1. Treatment credibility scale [ Time Frame: Week 2 ]
    Investigate if both conditions have equal credibility in order to rule out placebo

  2. Working alliance scale [ Time Frame: Week 5 ]
    Investigate if both conditions have equal working alliance in order to rule out non-specific factors



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02638792


Locations
Layout table for location information
Sweden
Karolinska Intitutet
Stockholm, Sweden, 17177
Sponsors and Collaborators
Karolinska Institutet
Investigators
Layout table for investigator information
Principal Investigator: Erik M Andersson, PhD, Psych. Karolinska Institutet
Layout table for additonal information
Responsible Party: Erik Andersson, PhD, Lic. psychologist, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02638792    
Other Study ID Numbers: REPN 2015/1698-31/1
First Posted: December 23, 2015    Key Record Dates
Last Update Posted: November 28, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No