Excessive WorryNCT03393156
Negative Meta-cognitions as a Causal Factor to Worry
A study testing Internet-based metacognitive therapy in people with Excessive Worry, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The purpose of this study is to investigate if an internet-based metacognitive therapy reduces negative metacognitions and if reductions negative metacognitions mediates reductions in worry. 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 metacognitive therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteSweden
- Study dates
- 6 Feb 2018to 6 May 2018
- 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 metacognitive therapy for pathological worry the last 2 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Negative Meta-cognitions as a Causal Factor to Worry: A Randomized Controlled Trial
The purpose of this study is to investigate if an internet-based metacognitive therapy reduces negative metacognitions and if reductions negative metacognitions mediates reductions in worry.
Read the 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.
- Conditions
- Excessive Worry
- Being tested
- Internet-based metacognitive therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based metacognitive therapyBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Internet-based metracognitive therapy | Experimental | 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). Receives: Behavioral: Internet-based metacognitive therapy |
| Wait-list | 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, 6 and 12 months later using the same questionnaires as the treatment group. |
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, weekly measurements, and at 6 and 12 months after treatment has ended.
Measured: Weekly measurements week 0-10, 6 and 12 months follow-up
Negative beliefs about uncontrollability of thoughts and danger in the Meta Cognitions Questionnaire (MCQ-30)
Change in Negative beliefs about uncontrollability of thoughts and danger, weekly measurements, and at 6 and 12 months after treatment has ended.
Measured: Weekly measurements week 0-10, 6 and 12 months follow-up
Secondary outcomes (8)
Montgomery Åsberg Depression Rating Scale (MADRS-S)
Change in depression from baseline to Week 10 and at 6 and 12 months after treatment has ended.
Measured: Week 0, Week 10, 6 and 12 months follow-up
Euroqol, EQ-5D
Change in general health from baseline to Week 10 and at 6 and 12 months after treatment has ended
Measured: 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]
Change in economic costs from baseline to Week 10 and at 6 and 12 months after treatment has ended
Measured: Week 0, Week 10, 6 and 12 months follow-up
Meta Cognitions Questionnaire (MCQ-30)
Change in metacognitions (all subscales as a total sum) weekly and at 6- and 12 months after treatment has ended.
Measured: Weekly measurements, 6 and 12 months follow-up
Cognitive Avoidance Questionnaire (CAQ)
Change in cognitive avoidance from baseline to Week 10 and at 6- and 12 months after treatment has ended
Measured: Week 0, Week 10, 6 and 12 months follow-up
Adverse Events
Number of adverse events from baseline to Week 10 and at 6 and 12 months
Measured: Week 10, 6 and 12 months follow-up
Contrast avoidance questionnaire
Change in contrast avoidance from baseline to Week 10 and at 6- and 12 months after treatment has ended
Measured: Week 0, Week 10, 6 and 12 months follow-up
Patient health questionnaire 2 items (PHQ-2)
Change in depressive symptoms weekly measurements, and at 6 and 12 months after treatment has ended.
Measured: Week 0 - Week 10 (weekly measurements), 6 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 posted8 Jan 2018
- Study start6 Feb 2018
- Primary completion6 May 2018
- Study completion6 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 108 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
- NCT03393156
- Sponsor's protocol ID
- 2017/1998-31
- Status last verified
- Aug 2018
- First submitted
- 2 Jan 2018
- Last updated
- 7 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wahlund T, Hesser H, Perrin S, Johansson S, Huhn V, Sorhus S, Lindskog S, Serlachius E, Hedman-Lagerlof E, Ljotsson B, Andersson E. Therapist-guided online metacognitive intervention for excessive worry: a randomized controlled trial with mediation analysis. Cogn Behav Ther. 2022 Jan;51(1):21-41. doi: 10.1080/16506073.2021.1937695. Epub 2021 Jul 20.
PubMed 34283004
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Negative Meta-cognitions as a Causal Factor to Worry: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03393156
- Acronym / sponsor ID
- 2017/1998-31
- Conditions
- Excessive Worry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 6 Feb 2018 (actual)
- Primary completion
- 6 May 2018 (actual)
- Study completion
- 6 May 2018 (actual)
- First posted
- 8 Jan 2018 (actual)
- 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 investigate if an internet-based metacognitive therapy reduces negative metacognitions and if reductions negative metacognitions mediates reductions in worry.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet-based metracognitive therapy | Experimental | Behavioral: Internet-based metacognitive therapyThe 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). |
| Wait-list | 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, 6 and 12 months later using the same questionnaires as the treatment group. |
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 metacognitive therapyInternet-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 | Behavioural | Internet-based metracognitive therapy |
Primary outcome
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.
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
Change in Negative beliefs about uncontrollability of thoughts and danger, weekly measurements, and at 6 and 12 months after treatment has ended.
8 secondary outcomes
Montgomery Åsberg Depression Rating Scale (MADRS-S)
Time frame: Week 0, Week 10, 6 and 12 months follow-up
Euroqol, EQ-5D
Time frame: 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
Meta Cognitions Questionnaire (MCQ-30)
Time frame: Weekly measurements, 6 and 12 months follow-up
Cognitive Avoidance Questionnaire (CAQ)
Time frame: Week 0, Week 10, 6 and 12 months follow-up
Adverse Events
Time frame: Week 10, 6 and 12 months follow-up
Contrast avoidance questionnaire
Time frame: Week 0, Week 10, 6 and 12 months follow-up
Patient health questionnaire 2 items (PHQ-2)
Time frame: Week 0 - Week 10 (weekly measurements), 6 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 7 Aug 2018.
- Derived from this study: PubMed 34283004Wahlund T, Hesser H, Perrin S, Johansson S, Huhn V, Sorhus S, Lindskog S, Serlachius E, Hedman-Lagerlof E, Ljotsson B, Andersson E. Therapist-guided online metacognitive intervention for excessive worry: a randomized controlled trial with mediation analysis. Cogn Behav Ther. 2022 Jan;51(1):21-41. doi: 10.1080/16506073.2021.1937695. Epub 2021 Jul 20.
- 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 metacognitive 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 7 Aug 2018. 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: Weekly measurements week 0-10, 6 and 12 months follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03393156, which also lists 1 linked publication.
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 7 Aug 2018.