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Completed

NCT Number: NCT02638792

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

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.

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Key information

Conditions

Excessive Worry

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Intitutet

Stockholm, 17177, Sweden

About this study

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

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
  • 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.

Treatment and study plan

Internet-based exposure therapy (I-ET)

Behavioral

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.

Internet-based stress management therapy

Behavioral

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.

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 23, 2015
Registry last updated
Nov 28, 2017

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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