NCT04921280

Effectiveness of ICBT for Severe Health Anxiety in Clinical Psychiatry.

Effectiveness of Internet-based Cognitive Behavior Therapy for Severe Health Anxiety in Clinical Psychiatry.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 456 (actual)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Severe health anxiety is a prevalent disorder, leading to considerable distress and is associated with high societal costs. Internet-based cognitive behaviour therapy is a method to improve access to evidence-based psychological treatments and it has shown to be efficacious in the treatment of severe health anxiety in several randomized controlled trials. However, there is limited knowledge of its effectiveness and application in clinical psychiatric care. The aim of this study is to evaluate the clinical effectiveness of internet-based cognitive therapy for severe health anxiety within regular psychiatric care. The investigators will conduct at a cohort-study with a pretest-posttest design investigating consecutively recruited patients from May 2018 to April 2021 in an outpatient psychiatric clinic specialised in delivering ICBT. The treatment content has been successfully tested in previous efficacy studies and will be delivered during 13 weeks. The primary outcome measure will be the gold standard SHAI and a within-group design with repeated measures will be used in the primary analysis. It is estimated that 400 patients will receive treatment during this period and thus be included in the study, if consenting. 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. The effect size is expected to be somewhat smaller than in research trials but still moderate to large (d \> 0.5).

Conditions

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

Interventions

Type	Name	Description
BEHAVIORAL	Internet based Cognitive Behavioural Therapy	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.

Timeline

• Start date: 2018-04-01
• Primary completion: 2021-03-15
• Completion: 2021-03-15
• First posted: 2021-06-10
• Last updated: 2021-09-29

Locations

1 site across 1 country: Sweden