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Completed

NCT Number: NCT02331537

Internet-based Exposure Therapy for Excessive Worry

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet

Stockholm, Stockholm County, 17177, Sweden

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Internet-based cognitive-behavior therapy

Behavioral

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Internet-based Exposure Therapy for Excessive Worry: A Randomized Trial

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jan 6, 2015
Registry last updated
Sep 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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