Excessive WorryNCT02638792
Internet-Based Exposure Therapy Vs. Stress-Management Training for Worry
A study testing Internet-based exposure therapy (I-ET) and Internet-based stress management therapy in people with Excessive Worry, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Excessive Worry
- What is being tested?
- Internet-based exposure therapy (I-ET) and Internet-based stress management therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 311 participants
- Where
- 1 siteSweden
- Study dates
- Dec 2015to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients
- ≥ 18 years
- Situated in Sweden
- Informed consent
- PSWQ score more than 56 points
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Internet-Based Exposure Therapy Vs. Stress-Management Training for Worry: A Randomized Controlled Trial
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.
Read the detailed description
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
- Conditions
- Excessive Worry
- Being tested
- Internet-based exposure therapy (I-ET), Internet-based stress management therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based exposure therapy (I-ET)Behavioural
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 therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Internet-based exposure therapy | Experimental | 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. Receives: Behavioral: Internet-based exposure therapy (I-ET) |
| Internet-based stress management therapy | Active comparator | 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. Receives: Behavioral: Internet-based stress management therapy |
| Waitlist | No intervention | When the active treatment groups have finished treatment (W11), the WL group will be able to start active treatment and be assessed at post-treatment, and 4, 12 months later using the same questionnaires as the treatment group. The participants will be able to choose which treatment they receive i.e. no randomization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Penn State Worry Questionnaire (PSWQ)
Change in worry from baseline to Week 10 and at 4- and 12 months after treatment has ended.
Measured: week 0, week 10 (weekly measurements), at 4 months follow up, 12 months follow up.
Secondary outcomes (10)
Montgomery Åsberg Depression Rating Scale (MADRS-S)
Change in depression from baseline to Week 10 and at 4- and 12 months after treatment has ended.
Measured: Week 0, Week 10, 4 and 12 months follow-up
Euroqol, EQ-5D
Change in general health from baseline to Week 10 and at 4- and 12 months after treatment has ended
Measured: Week 0, Week 10, 4 and 12 months follow-up
Cognitive Avoidance Questionnaire (CAQ)
Change in cognitive avoidance from baseline to Week 10, at 4- and 12 after treatment has ended, and weekly during treatment
Measured: Week 0, Week 10, at 4 and 12 months follow up and weekly during treatment
Intolerance of uncertainty scale
Change in thought control efforts from baseline to Week 10, at 4- and 12 months after treatment has ended, and weekly during treatment
Measured: Week 0, Week 10, at 4 and 12 months follow-up, and weekly during treatment
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
Measured: Week 0, Week 10, 4 and 12 months follow-up
Brunnsviken Quality of Life Questionnaire (BBQ)
Change in self-perceived quality of life from baseline to week 10 and at 4 and 12 months after treatment has ended
Measured: Week 0, Week 10, 4 and 12 months follow-up
Thought supression subscale of the Cognitive Avoidance Questionnaire (CAQ)
Weekly change in thought supression from baseline to Week 10
Measured: Week 0 - Week 10 (weekly measurements)
The self-regulation subscale of the Multidimensional Assessment of Interoceptive Awareness
Weekly change in self-regulation from baseline to Week 10
Measured: Week 0 - Week 10 (weekly measurements)
Patient Health Questionnaire-2
Weekly change in depressive symptom from baseline to Week 10
Measured: Week 0 - Week 10 (weekly measurements)
Adverse Events
Number of adverse events from baseline to Week 10 and at 4 and 12 months
Measured: Week 3, week 8, week 10, 4 and 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Excessive WorryStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 311 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erik Andersson, Karolinska Institutet
- Investigators
- Erik M Andersson, PhD, Psych., Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02638792
- Sponsor's protocol ID
- REPN 2015/1698-31/1
- Status last verified
- Nov 2017
- First submitted
- 19 Dec 2015
- Last updated
- 28 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-Based Exposure Therapy Vs. Stress-Management Training for Worry: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02638792
- Acronym / sponsor ID
- REPN 2015/1698-31/1
- Conditions
- Excessive Worry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 311 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 23 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Internet-based exposure therapy | Experimental | Behavioral: Internet-based exposure therapy (I-ET)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 | Active comparator | Behavioral: Internet-based stress management therapyThe 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. |
| Waitlist | No intervention | –When the active treatment groups have finished treatment (W11), the WL group will be able to start active treatment and be assessed at post-treatment, and 4, 12 months later using the same questionnaires as the treatment group. The participants will be able to choose which treatment they receive i.e. no randomization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Outpatients
- ≥ 18 years
- Situated in Sweden
- Informed consent
- PSWQ score more than 56 points
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-based exposure therapy (I-ET)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. | Behavioural | Internet-based exposure therapy |
| Internet-based stress management therapyThe 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. | Behavioural | Internet-based stress management therapy |
Primary outcome
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.
10 secondary outcomes
Montgomery Åsberg Depression Rating Scale (MADRS-S)
Time frame: Week 0, Week 10, 4 and 12 months follow-up
Euroqol, EQ-5D
Time frame: Week 0, Week 10, 4 and 12 months follow-up
Cognitive Avoidance Questionnaire (CAQ)
Time frame: Week 0, Week 10, at 4 and 12 months follow up and weekly during treatment
Intolerance of uncertainty scale
Time frame: Week 0, Week 10, at 4 and 12 months follow-up, and weekly during treatment
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
Brunnsviken Quality of Life Questionnaire (BBQ)
Time frame: Week 0, Week 10, 4 and 12 months follow-up
Thought supression subscale of the Cognitive Avoidance Questionnaire (CAQ)
Time frame: Week 0 - Week 10 (weekly measurements)
The self-regulation subscale of the Multidimensional Assessment of Interoceptive Awareness
Time frame: Week 0 - Week 10 (weekly measurements)
Patient Health Questionnaire-2
Time frame: Week 0 - Week 10 (weekly measurements)
Adverse Events
Time frame: Week 3, week 8, week 10, 4 and 12 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2017.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik M Andersson, PhD, Psych. principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based exposure therapy (I-ET) and Internet-based stress management therapy in people with Excessive Worry, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Penn State Worry Questionnaire (PSWQ) (time frame: week 0, week 10 (weekly measurements), at 4 months follow up, 12 months follow up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2017.