- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03393156
Negative Meta-cognitions as a Causal Factor to Worry
Negative Meta-cognitions as a Causal Factor to Worry: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The aim is primary mechanistic i.e. we want to investigate if a clear change in negative metacognitions in one group (internet-based metacognitive therapy; I-MCT) relative to another (waiting list) mediates subsequent reductions in worry.
Our hypotheses are the following:
- I-MCT reduces both negative metacognitions (Beliefs about uncontrollability and danger of worry) and worry from baseline to week 10,
reductions in negative metacognitions will significantly mediate subsequent reductions in worry.
Additionally we hypothesize that patients who score low at baseline in negative metacognitions will not show this process pattern i.e.
patients who score low at baseline in negative metacognitions will benefit less from treatment (moderator hypothesis)
and consequently
- will not show the same mediation response as stipulated in hypothesis 2 (moderated mediator hypothesis).
Trial Design: Randomized controlled trial with waitlist control. Duration: Ten weeks Primary Endpoint: Change in worry symptoms and negative metacognitions from baseline to Week 10. Long term follow-up is also investigated (baseline to 6-months after treatment completion and baseline to 12-months after treatment completion).
Efficacy Parameters: Penn State Worry Questionnaire (PSWQ) and the negative metacognitions subscale (negative beliefs about uncontrollability of thoughts and danger) of the Meta-Cognitions Questionnaire 30 items.
Safety Parameters: Adverse Events is assessed at week 10.
Description of Trial Subjects: Patients > 18 years old with a PSWQ score more than 56 points Number of Subjects: Anticipated 140
Analysis plan:
To address the hypotheses in the study growth modeling analysis using the expectation-maximization algorithm and maximum-likelihood estimation will be employed. The treatment effect on negative metacognitions and worry will examined by comparing average growth rates between treatment and control group over the assessment period. Growth modeling for longitudinal mediation will be employed to test (a) the overall mediated effect on worry using individual trajectories of change on the proposed mediator (i.e., negative metacognitions) and outcome (i.e., worry), and (b) mediated baseline by treatment moderation effect using the initial assessment of negative metacognitions as the moderator of the indirect (i.e., mediated) and direct effect of treatment. Competing mediator is depressive symptoms using the PHQ-2.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Stockholm, Sweden, 17177
- Karolinska Intitutet
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 metacognitive therapy for pathological worry the last 2 years.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Internet-based metracognitive therapy
The internet-based metacognitive therapy group receives a ten-week long treatment, which is based on the book "Metacognitive therapy for depression and anxiety" by Adrian Wells (2011).
|
Internet-based metacognitive therapy on a safe internet platform.
Treatment is divided into ten 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 hour
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NO_INTERVENTION: Wait-list
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, 6 and 12 months later using the same questionnaires as the treatment group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Penn State Worry Questionnaire (PSWQ)
Time Frame: Weekly measurements week 0-10, 6 and 12 months follow-up
|
Change in worry, weekly measurements, and at 6 and 12 months after treatment has ended.
|
Weekly measurements week 0-10, 6 and 12 months follow-up
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Negative beliefs about uncontrollability of thoughts and danger in the Meta Cognitions Questionnaire (MCQ-30)
Time Frame: Weekly measurements week 0-10, 6 and 12 months follow-up
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Change in Negative beliefs about uncontrollability of thoughts and danger, weekly measurements, and at 6 and 12 months after treatment has ended.
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Weekly measurements week 0-10, 6 and 12 months follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Montgomery Åsberg Depression Rating Scale (MADRS-S)
Time Frame: Week 0, Week 10, 6 and 12 months follow-up
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Change in depression from baseline to Week 10 and at 6 and 12 months after treatment has ended.
|
Week 0, Week 10, 6 and 12 months follow-up
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Euroqol, EQ-5D
Time Frame: Week 0, Week 10, 6 and 12 months follow-up
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Change in general health from baseline to Week 10 and at 6 and 12 months after treatment has ended
|
Week 0, Week 10, 6 and 12 months follow-up
|
Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P) [Time Frame: Week 0, Week 10, 6 and 12 months follow-up]
Time Frame: Week 0, Week 10, 6 and 12 months follow-up
|
Change in economic costs from baseline to Week 10 and at 6 and 12 months after treatment has ended
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Week 0, Week 10, 6 and 12 months follow-up
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Meta Cognitions Questionnaire (MCQ-30)
Time Frame: Weekly measurements, 6 and 12 months follow-up
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Change in metacognitions (all subscales as a total sum) weekly and at 6- and 12 months after treatment has ended.
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Weekly measurements, 6 and 12 months follow-up
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Cognitive Avoidance Questionnaire (CAQ)
Time Frame: Week 0, Week 10, 6 and 12 months follow-up
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Change in cognitive avoidance from baseline to Week 10 and at 6- and 12 months after treatment has ended
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Week 0, Week 10, 6 and 12 months follow-up
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Adverse Events
Time Frame: Week 10, 6 and 12 months follow-up
|
Number of adverse events from baseline to Week 10 and at 6 and 12 months
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Week 10, 6 and 12 months follow-up
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Contrast avoidance questionnaire
Time Frame: Week 0, Week 10, 6 and 12 months follow-up
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Change in contrast avoidance from baseline to Week 10 and at 6- and 12 months after treatment has ended
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Week 0, Week 10, 6 and 12 months follow-up
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Patient health questionnaire 2 items (PHQ-2)
Time Frame: Week 0 - Week 10 (weekly measurements), 6 and 12 months follow-up
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Change in depressive symptoms weekly measurements, and at 6 and 12 months after treatment has ended.
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Week 0 - Week 10 (weekly measurements), 6 and 12 months follow-up
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Erik M Andersson, PhD, Psych., Karolinska Institutet
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2017/1998-31
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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