NCT03393156

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 8, 2018

Completed
29 days until next milestone

Study Start

First participant enrolled

February 6, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2018

Completed
Last Updated

August 7, 2018

Status Verified

August 1, 2018

Enrollment Period

3 months

First QC Date

January 2, 2018

Last Update Submit

August 6, 2018

Conditions

Excessive Worry

Outcome Measures

Primary Outcomes (2)

  • Penn State Worry Questionnaire (PSWQ)

    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

  • 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.

    Weekly measurements week 0-10, 6 and 12 months follow-up

Secondary Outcomes (8)

  • Montgomery Åsberg Depression Rating Scale (MADRS-S)

    Week 0, Week 10, 6 and 12 months follow-up

  • Euroqol, EQ-5D

    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]

    Week 0, Week 10, 6 and 12 months follow-up

  • Meta Cognitions Questionnaire (MCQ-30)

    Weekly measurements, 6 and 12 months follow-up

  • Cognitive Avoidance Questionnaire (CAQ)

    Week 0, Week 10, 6 and 12 months follow-up

  • +3 more secondary outcomes

Study Arms (2)

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).

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.

Interventions

Internet-based metacognitive therapyBEHAVIORAL

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

Internet-based metracognitive therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Outpatients
  • ≥ 18 years
  • Situated in Sweden
  • Informed consent
  • PSWQ score more than 56 points

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Intitutet

Stockholm, 17177, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 34283004DERIVED

Study Officials

  • Erik M Andersson, PhD, Psych.

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Lic. psychologist

Study Record Dates

First Submitted

January 2, 2018

First Posted

January 8, 2018

Study Start

February 6, 2018

Primary Completion

May 6, 2018

Study Completion

May 6, 2018

Last Updated

August 7, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)