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Internet-based Exposure Therapy for Excessive Worry

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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

Tracking Information
First Submitted Date  ICMJE January 1, 2015
First Posted Date  ICMJE January 6, 2015
Last Update Posted Date September 1, 2015
Study Start Date  ICMJE January 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 2, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 2, 2015)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Internet-based Exposure Therapy for Excessive Worry
Official Title  ICMJE Internet-based Exposure Therapy for Excessive Worry: A Randomized Trial
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Excessive Worry
  • Rumination
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Internet-based cognitive-behavior therapy
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: January 2, 2015)
140
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02331537
Other Study ID Numbers  ICMJE 2014-1944-31-5
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Erik Andersson, Karolinska Institutet
Study Sponsor  ICMJE Karolinska Institutet
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Erik M Andersson, PhD Karolinska Institutet
PRS Account Karolinska Institutet
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP