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Internet-based Exposure Therapy for Excessive Worry

Primary Purpose

Excessive Worry, Rumination

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Internet-based cognitive-behavior therapy
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Excessive Worry

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Karolinska Institutet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Internet-based cognitive-behavior therapy

Waitlist

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Penn State Worry Questionnaire (PSWQ)
Change in worry from baseline to Week 10, and at 4- and 12 months after treatment has ended.

Secondary Outcome Measures

Meta Cognitions Questionnaire (MCQ-30)
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)
Change in depression from baseline to Week 10 and at 4- and 12 months after treatment has ended.
Euroqol (EQ-5D)
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)
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)
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)
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)
Change in economic costs from baseline to Week 10 and at 4- and 12 months after treatment has ended.
Intolerance of Uncertainty Scale (IUS)
Change in tolerance of uncertainty from baseline to Week 10 and at 4- and 12 months after treatment has ended.

Full Information

First Posted
January 1, 2015
Last Updated
August 31, 2015
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT02331537
Brief Title
Internet-based Exposure Therapy for Excessive Worry
Official Title
Internet-based Exposure Therapy for Excessive Worry: A Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Excessive Worry, Rumination

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Internet-based cognitive-behavior therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Internet-based cognitive-behavior therapy
Intervention Description
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 Outcome Measure Information:
Title
Penn State Worry Questionnaire (PSWQ)
Description
Change in worry from baseline to Week 10, and at 4- and 12 months after treatment has ended.
Time Frame
Week 0, Week 10, Long term follow-up at 4-, and 12-months after treatment has ended
Secondary Outcome Measure Information:
Title
Meta Cognitions Questionnaire (MCQ-30)
Description
Change in metacognitions from baseline to Week 10 and at 4- and 12 months after treatment has ended.
Time Frame
Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended
Title
Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S)
Description
Change in depression from baseline to Week 10 and at 4- and 12 months after treatment has ended.
Time Frame
Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended
Title
Euroqol (EQ-5D)
Description
Change in general health from baseline to Week 10 and at 4- and 12 months after treatment has ended.
Time Frame
Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended
Title
Hospital anxiety and depression scale (HADS)
Description
Change in anxiety and depression from baseline to Week 10 and at 4- and 12 months after treatment has ended.
Time Frame
Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended
Title
Spontaneous Use of Imagery Scale (SUIS)
Description
Change in Spontaneous Use of Imagery from baseline to Week 10 and at 4- and 12 months after treatment has ended.
Time Frame
Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended
Title
Cognitive Avoidance Questionnaire (CAQ)
Description
Change in cognitive avoidance from baseline to Week 10 and at 4- and 12 months after treatment has ended.
Time Frame
Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended
Title
Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)
Description
Change in economic costs from baseline to Week 10 and at 4- and 12 months after treatment has ended.
Time Frame
Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended
Title
Intolerance of Uncertainty Scale (IUS)
Description
Change in tolerance of uncertainty from baseline to Week 10 and at 4- and 12 months after treatment has ended.
Time Frame
Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik M Andersson, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Institutet
City
Stockholm
ZIP/Postal Code
17177
Country
Sweden

12. IPD Sharing Statement

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Internet-based Exposure Therapy for Excessive Worry

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