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 for Excessive 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: NCT02331537
Recruitment Status : Completed
First Posted : January 6, 2015
Last Update Posted : September 1, 2015
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 effective in reducing excessive worry amongst patients who suffer from this problem.

Condition or disease Intervention/treatment Phase
Excessive Worry Rumination Behavioral: Internet-based cognitive-behavior therapy Not Applicable

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Internet-based Exposure Therapy for Excessive Worry: A Randomized Trial
Study Start Date : January 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: Internet-based cognitive-behavior therapy
Internet-based cognitive-behavior therapy on a safe internet platform. Treatment is divided into seven modules, each containing homework assignments . The participants will be assigned a therapist that they can contact through a message system in the platform and expect answer within 24 hours.

No Intervention: Waitlist
Waitlist control that will get the internet-based treatment when the first group has finished (i.e. Week 10). There are no active treatment for these participants at all.



Primary Outcome Measures :
  1. Penn State Worry Questionnaire (PSWQ) [ Time Frame: 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 :
  1. Meta Cognitions Questionnaire (MCQ-30) [ Time Frame: 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.

  2. Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S) [ Time Frame: 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.

  3. Euroqol (EQ-5D) [ Time Frame: 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.

  4. Hospital anxiety and depression scale (HADS) [ Time Frame: 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.

  5. Spontaneous Use of Imagery Scale (SUIS) [ Time Frame: 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.

  6. Cognitive Avoidance Questionnaire (CAQ) [ Time Frame: 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.

  7. Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P) [ Time Frame: 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.

  8. Intolerance of Uncertainty Scale (IUS) [ Time Frame: 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.



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
  • Penn State Worry Questionnaire 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 Cognitive behavior therapy (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): NCT02331537


Locations
Layout table for location information
Sweden
Karolinska Institutet
Stockholm, Sweden, 17177
Sponsors and Collaborators
Karolinska Institutet
Investigators
Layout table for investigator information
Principal Investigator: Erik M Andersson, PhD Karolinska Institutet
Layout table for additonal information
Responsible Party: Erik Andersson, PhD, psychologist, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02331537    
Other Study ID Numbers: 2014-1944-31-5
First Posted: January 6, 2015    Key Record Dates
Last Update Posted: September 1, 2015
Last Verified: August 2015