Effectiveness of ICBT for Severe Health Anxiety in Clinical Psychiatry.

NCT04921280 | Completed

• 1 other identifier: 2011/2091-31/3
• Study Type: observational
• Target: 456
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the clinical effectiveness of internet-based cognitive therapy for severe health anxiety within regular psychiatric care. A longitudinal cohort study will be conducted investigating 400 patients who have received ICBT for severe health anxiety between 2018-2020 in an outpatient psychiatric clinic providing Internet-based treatment. The primary outcome measure will be the Short Health Anxiety Inventory, SHAI, and a within-group design with repeated measures will be used for primary analysis. It is hypothesized that ICBT will be associated with a significant reduction in health anxiety as measured with SHAI, both after treatment and at six-month follow-up.

Conditions

Health Anxiety; Hypochondriasis; Illness Anxiety Disorder; Somatic Symptom Disorder; Severe Health Anxiety; Hypochondriacal Disorder, Unspecified

Outcome Measures

Primary Outcomes (1)

• The short health anxiety inventory, SHAI

  A 14-item self-report measure of health anxiety severity. Total scores on the scale range from 0 to 42 with higher scores indicating a worse outcome (more severe symptoms of health anxiety).

  Change from baseline (week 0) to post-treatment (week 12)

Secondary Outcomes (3)

• Montgomery Asberg Depression Rating Scale Self Rate, MADRS-S

  Change from baseline (week 0) to post-treatment (week 12)

• Generalised Anxiety Disorder 7-item scale, GAD-7

  Change from baseline (week 0) to post-treatment (week 12)

• EQ5D

  Change from baseline (week 0) to post-treatment (week 12)

Study Arms (1)

Treatment group

Patients who have received treatment for severe health anxiety at the Internet Psychiatry Clinic, Psychiatry Southwest, Karolinska University Hospital Huddinge between April 2018 to April 2021.

Behavioral: Internet based Cognitive Behavioural Therapy

Interventions

Internet based Cognitive Behavioural Therapy BEHAVIORAL

The treatment program consists of 12 chapters or "modules" spread over 12 weeks and contains written information, different exercises and weekly homework assignment. Patients get access to the CBT program via an internet portal and they have weekly contact with a licenced psychologist via encrypted email. Focus of the therapist support is to review the content of the weekly module, reinforce progress and engagement in therapy and assist with treatment difficulties. If needed, therapist can contact patients via telephone. Patients receive weekly reminders via SMS to login to the portal and fill out self-report measures.

Treatment group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients will receive treatment at the Internet Psychiatry Clinic (www.internetpsykiatri.se), Psychiatry Southwest, Karolinska University Hospital Huddinge. Patient can either apply for treatment through self-referral or through referral from primary or psychiatric care. Self-referred patients will register for treatment through a public e-service portal for health care (i.e.Vårdguiden; 1177.se). Prior to treatment, patients will complete an online screening battery of self-report questionnaires and undergo an assessment by psychiatrists, or resident physicians supervised by psychiatrists.

You may qualify if:

• Patients over 16 years of age
• Living in Sweden
• Primary diagnosis of hypochondriasis according to ICD-10
• Able to read and write
• Have access to a computer or other device with an Internet connection
• If on medication, have a stable dose of psychotropic medication for 4 weeks prior to treatment
• Not having other psychiatric difficulties (e.g., ongoing substance abuse or a psychotic syndrome) that makes ICBT an unsuitable intervention

You may not qualify if:

• Patients with severe depression (clinician rated Montgomery-Asberg Depression Rating Scale- Self-Rated; MADRS-S and/or moderate to high risk of suicide in which monitoring is required
• Patients with low motivation, severe apathy, or difficulty concentrating
• Patients with psychosis
• Patients with untreated drug or alcohol problems
• Patients with reading and/or writing difficulties, including language difficulties;

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Study Sites (1)

M46: Karolinska Universitetssjukhuset, Psykiatri Sydväst Stockholm, Huddinge, Sweden, 141 86

Stockholm, 141 86, Sweden

Location

MeSH Terms

Conditions

Hypochondriasis

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders

Study Officials

• Volen Ivanov, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: June 10, 2021
• Study Start: April 1, 2018
• Primary Completion: March 15, 2021
• Study Completion: March 15, 2021
• Last Updated: September 29, 2021

Record last verified: 2021-09

Locations

SE (1)