NCT05446766

Brief Summary

This study investigates the feasibility and preliminary efficacy of a self-guided, exposure-based intervention for individuals who suffer from severe health anxiety. The study is a prospective single-group study based at Karolinska Institutet, Stockholm, Sweden, where 20-25 adults with DSM-5 Illness anxiety disorder or Somatic symptom disorder are enrolled in 8 weeks of unguided exposure-based treatment via the Internet. Outcomes include self-reported health anxiety symptoms, credibility and expectancy, adherence to the treatment protocol, client satisfaction, and negative events.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 7, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

September 6, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2023

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

7 months

First QC Date

June 21, 2022

Last Update Submit

October 6, 2023

Conditions

Illness Anxiety DisorderSomatic Symptom Disorder

Keywords

Self-guided interventionSelf-helpDigital interventionExposure therapy

Outcome Measures

Primary Outcomes (6)

  • Change in Health anxiety symptoms

    The Short health anxiety inventory - 14 item (SHAI-14). Higher scores indicate greater severity of health anxiety. Scores range from 0 to 42.

    pre-treatment assessment to 12 weeks after post-treatment assessment

  • Adherence to the treatment: amount of exposures

    Will be determined by the amount of exposure exercises reported in the program and in a weekly questionnaire. Acceptable level of adherence will be set to at least 50 % of participants working actively with exposure a majority of the days during a week for 4 weeks or more.

    Post-treatment assessment (immediately after treatment)

  • Adherence to the treatment: number of modules

    Will be determined by the number of modules completed by the participants.

    Post-treatment assessment (immediately after treatment)

  • Adherence to the treatment: types of exposure

    Will be determined by the number of different types of exposure exercises performed by participants. At the end of the program, participants will answer yes or no to whether they engaged in each component (type of exposure exercise) of the intervention.

    Post-treatment assessment (immediately after treatment)

  • Unintended treatment effects

    Participants will be asked to state whether they had experienced any negative or unwanted effects of the treatment. If answering 'Yes', participants will be asked to specify the adverse event in free text. Adverse events will primarily be reported as the total number of reported events.

    Post-treatment assessment (immediately after treatment)

  • Satisfaction with treatment

    Client Satisfaction Questionnaire (CSQ-8). Scores range from 8-32 with higher scores indicating greater satisfaction. An average Client Satisfaction Questionnaire-8 score of at least 22 will provide support for the acceptability and feasibility of this intervention.

    Post-treatment assessment (immediately after treatment)

Secondary Outcomes (15)

  • Change in Health anxiety symptoms

    pre-treatment assessment to Post-treatment assessment (immediately after treatment)

  • Change in Health anxiety symptoms

    pre-treatment assessment to 4 weeks after post-treatment assessment

  • Change in depressive symptoms

    pre-treatment assessment to12 weeks after post-treatment assessment

  • Change in depressive symptoms

    pre-treatment assessment to Post-treatment assessment (immediately after treatment)

  • Change in depressive symptoms

    pre-treatment assessment to 4 weeks after post-treatment assessment

  • +10 more secondary outcomes

Other Outcomes (1)

  • Telephone interview

    immediately after treatment

Study Arms (1)

Self-guided Exposure-based Digital Intervention for Health Anxiety

EXPERIMENTAL

Eight weeks of self-guided exposure-based intervention delivered digitally, via the Internet.

Behavioral: Self-guided Exposure-based Digital Intervention for Health Anxiety

Interventions

Self-guided Exposure-based Digital Intervention for Health AnxietyBEHAVIORAL

An 8-week self-guided internet based CBT intervention which consists of text, exercises, examples and automated support. The format, potentially more accessible compared to traditional ICBT, will be developed with the aim to enhance treatment comprehension and motivation in the participants. The program consists of eight modules (chapters) where the main therapeutic focus is exposure with response prevention. Participant will be interviewed before the program starts, after 8 weeks and 3 months after the program ends. If in need for technical support, participant will be able to ask for assistance via the program and will then be contacted by a clinician via telephone within a couple of days.

Self-guided Exposure-based Digital Intervention for Health Anxiety

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 18 years
  • A principal diagnosis Illness anxiety disorder or somatic symptom disorder (DSM-V)
  • Access to a computer and the internet
  • No serious medical illness
  • Participants on psychotropic medication must have been on a stable dose for the last 4 weeks prior to baseline assessment

You may not qualify if:

  • Difficulties to read or write that makes it hard to understand the content of the intervention
  • Currently receiving similar psychological treatment for anxiety
  • High risk of suicide
  • Diagnosed with psychosis disorder or bipolar disorder
  • Ongoing substance dependence
  • Have an urgent need for more intensive psychiatric care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centrum för Psykiatriforskning

Stockholm, Sweden

Location

Related Publications (1)

  • Osterman S, Hentati A, Forsell E, Axelsson E, Hedman-Lagerlof E, Lindefors N, Ivanov VZ, Kraepelien M. Brief digital self-care intervention for health anxiety in a Swedish Medical University Clinic: a prospective single-group feasibility study. BMJ Open. 2023 Dec 21;13(12):e077376. doi: 10.1136/bmjopen-2023-077376.

    PMID: 38135329DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Psychological intervention, patient-reported outcomes.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Licensed clinical psychologist, Principal investigator, PhD

Study Record Dates

First Submitted

June 21, 2022

First Posted

July 7, 2022

Study Start

September 6, 2022

Primary Completion

March 29, 2023

Study Completion

March 29, 2023

Last Updated

October 10, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Individual data will be available upon reasonable request.

Locations

SE(1)