Feasibility Evaluation of a Self-guided Exposure-based Digital Intervention for Health Anxiety

NCT ID: NCT05446766

Last Updated: 2023-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-06
• Study Completion Date: 2023-03-29

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.

Detailed Description

Background

Severe health anxiety (Corresponding to a DSM-5-diagnosis of Illness anxiety disorder or somatic symptom disorder) is a condition associated with high distress, disability and increased health service utilization. Therapist guided Internet delivered cognitive behavioural therapy (ICBT) is efficacious in the treatment of severe health anxiety and has the advantage of requiring less treatment support per patient compared to traditional CBT, thus making the treatment more cost effective. Despite this, the access to ICBT is limited as it requires the active participation of a therapist. Given the relatively high prevalence of individuals experiencing excessive health anxiety, there is need for research on more accessible treatment options.

Unguided self-care interventions have the potential to improve access to treatment and increase cost-effectiveness and have a more immediate scalability. Also, unguided interventions have the advantage of being more easily disseminated outside the traditional mental health care systems and thus, have the potential to reach patients with subclinical, yet distressful, health anxiety.

Aim

The overall aim of this study is to develop a new internet-delivered CBT program based on exposure and response prevention - without therapist support - for patients with severe health anxiety and to examine its feasibility and potential clinical efficacy.

Design

This is a prospective single-group feasibility study with a pre-post design where a total of 25 participants with Illness anxiety disorder or Somatic symptom disorder (suffering from health anxiety) according to the Diagnostic and statistical manual of mental disorders 5 (DSM-5) are enrolled in an 8 weeks unguided internet based treatment targeting exposure and response prevention. The study will evaluate patient-reported satisfaction, engagement and adherence to treatment protocol, credibility, safety and pre-post changes in health anxiety.

Conditions

Illness Anxiety Disorder; Somatic Symptom Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Self-guided Exposure-based Digital Intervention for Health Anxiety

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

Group Type: EXPERIMENTAL

Self-guided Exposure-based Digital Intervention for Health Anxiety

Intervention Type: BEHAVIORAL

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.

Interventions

Self-guided Exposure-based Digital Intervention for Health Anxiety

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Stockholm

OTHER_GOV

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Martin Kraepelien

Licensed clinical psychologist, Principal investigator, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Centrum för Psykiatriforskning

Stockholm, , Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 38135329 (View on PubMed)

Other Identifiers

HEALTHANXIETY1

Identifier Type: -

Identifier Source: org_study_id