Feasibility Test of the Treatment Program iACT-by Proxy - a Single Case Experimental Design

NCT04830605 | Completed DMC

• 1 other identifier: 1-10-72-296-20
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

Health anxiety by proxy is defined as parents' obsessive worries about their child's health. It is a newly described phenomenon, where the parent has persistent and distressing fears that his or her child may suffer from a serious disease that is being overlooked. These intrusive thoughts may lead to excessive attention directed towards their child's body and a tendency to interpret natural bodily sensations as unnatural and abnormal. As a consequence, parents with health anxiety by proxy may repetitively perform bodily inspections of their child. Besides the stress related to worrying about your child's health, the condition can also cause frequent and unnecessary medical examinations of the child. As a possible consequence of this parental behavior, the child may be at risk of developing similar maladaptive illness behaviors, illness perceptions and illness worries. Currently, the phenomenon is widely overlooked and no treatment for health anxiety by proxy exists. The aim of the study is to test the feasibility and possible effect of an internet-based treatment program for health anxiety by proxy (iACT-by-proxy) using a single-case experimental design. Design The iACT-by-proxy is being tested in a single-case experimental design with multiple baselines. In a multiple baseline design the participants have different baseline lengths but the same intervention and follow-up period. The rationale behind the different baseline lengths is that it will be evident if target outcome measures change at intervention entry, but not during baseline. Thus the participants' baseline-period functions as their own control. Hypotheses

• Patients will report a significant decrease in selected self-report measures of health anxiety by proxy answered every other day when comparing the baseline period to the interven-tion period.
• Patient self-report measures of health anxiety by proxy, emotional distress, and illness perception and catastrophizing when the child has symptoms will have decreased after intervention. Participants Parents assessed with health anxiety by proxy with children under 18years. Recruitment Participants are assessed with health anxiety by proxy using the Health Anxiety by Proxy Scale (HAPYS).Participants self-refer to the project through the webpage www.helbredsangst.dk. After diagnostic video-interview they are included in the project.

Conditions

Anxiety State; Anxiety Disorders

Keywords

Internet-based treatment; Single-case experimental design

Outcome Measures

Primary Outcomes (1)

• SMS-data

  Four questions assessing patients anxiety level is sent to the patient every day by sms.

  Up to 15 weeks

Secondary Outcomes (9)

• The health anxiety by proxy scale

  Baseline, 1-3 weeks, 9-11 weeks, 13-15 weeks

• The Adult Response to Children's Symptoms (ARCS) - parent form (revised)

  Baseline, 1-3 weeks, 9-11 weeks, 13-15 weeks

• Pain Catastrophizing Scale - parent version

  Baseline, 1-3 weeks, 9-11 weeks, 13-15 weeks

• The Whiteley-6 Index

  Baseline, 1-3 weeks, 9-11 weeks, 13-15 weeks

• SCL-8 (emotional distress)

  Baseline, 1-3 weeks, 9-11 weeks, 13-15 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

Internet-delivered treatment for parents with health anxiety on behalf of their child. Eight weeks with therapist support.

Behavioral: Internet-based treatment

Interventions

Internet-based treatment BEHAVIORAL

The intervention is an internet-based psychotherapy treatment with eight modules based on acceptance and commitment therapy and with written therapist contact through eight weeks.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Parents of age
• Assessed with severe health anxiety by proxy
• At least one child under 18 years
• Healthy children without severe hospital-treatment-requiring diagnoses or disabilities
• Read, write and speak Danish

You may not qualify if:

• Comorbid diagnoses of substance abuse, bipolar disorder, psychotic disorders (ICD-10: F20-29) or autism spectrum disorder.
• Recently starting up psychotropic drug (with-in the last two months)
• Suicidal risk

Sponsors & Collaborators

• Aarhus University Hospital: lead
• University of Aarhus: collaborator

Study Sites (1)

Aarhus University hospital

Aarhus, Region Midt, 8200, Denmark

Location

Related Publications (25)

• Lockhart E. Health anxiety in children and parents. BMJ. 2016 May 24;353:i2891. doi: 10.1136/bmj.i2891. No abstract available.

  PMID: 27222022 BACKGROUND

• Thorgaard MV, Frostholm L, Walker L, Jensen JS, Morina B, Lindegaard H, Salomonsen L, Rask CU. Health anxiety by proxy in women with severe health anxiety: A case control study. J Anxiety Disord. 2017 Dec;52:8-14. doi: 10.1016/j.janxdis.2017.09.001. Epub 2017 Sep 11.

  PMID: 28950218 BACKGROUND

• Thorgaard MV, Frostholm L, Rask CU. Childhood and family factors in the development of health anxiety: A systematic review. Children's Health Care. 2017:1-41

  BACKGROUND

• Thorgaard MV, Frostholm L, Walker LS, Stengaard-Pedersen K, Karlsson MM, Jensen JS, Fink P, Rask CU. Effects of maternal health anxiety on children's health complaints, emotional symptoms, and quality of life. Eur Child Adolesc Psychiatry. 2017 May;26(5):591-601. doi: 10.1007/s00787-016-0927-1. Epub 2016 Dec 1.

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• Hayes SC, Strosahl K, Wilson KG. Acceptance and commitment therapy : the process and practice of mindful change. 2. ed. ed. New York: Guilford Press; 2012. 402

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• Hoffmann D, Rask CU, Hedman-Lagerlof E, Jensen JS, Frostholm L. Efficacy of internet-delivered acceptance and commitment therapy for severe health anxiety: results from a randomized, controlled trial. Psychol Med. 2021 Nov;51(15):2685-2695. doi: 10.1017/S0033291720001312. Epub 2020 May 14.

  PMID: 32404226 BACKGROUND

• Morley S. Single-Case Methods in Clinical Psychology: A Practical Guide. 1 ed. Milton: Routledge; 2018.

  BACKGROUND

• Hoffmann D, Rask CU, Hedman-Lagerlof E, Eilenberg T, Frostholm L. Accuracy of self-referral in health anxiety: comparison of patients self-referring to internet-delivered treatment versus patients clinician-referred to face-to-face treatment. BJPsych Open. 2019 Sep 9;5(5):e80. doi: 10.1192/bjo.2019.54.

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• Ingeman K, Frostholm L, Wellnitz KB, Wright K, Frydendal DH, Onghena P, Rask CU. Internet-Delivered Therapy for Parents With Health Anxiety by Proxy: Protocol for a Single-Case Experimental Design Study. JMIR Res Protoc. 2023 Nov 24;12:e46927. doi: 10.2196/46927.

  PMID: 37999936 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Charlotte Ulrikka Rask, Med.Dr

  Aarhus University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychologist

Model Details: The study is a single-case experimental design with multiple baselines. This means the participants have different baseline lengths but the same intervention and follow-up period and that they all receive the same intervention. The baseline and intervention period serves as two study conditions, a control (baseline) and a treatment condition (intervention) with N equally spaced measurement occasions. The baseline length is randomly assigned to the participants and serves as each participants' own control-condition. This makes it possible to have a small number of participants. If the intervention shows effect a change in the anxiety level will be detected during the intervention period regardless of when the intervention-period was initiated.

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: April 5, 2021
• Study Start: June 1, 2022
• Primary Completion: May 8, 2023
• Study Completion: May 8, 2023
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 6 months and ending 36 months following article publication.
• Access Criteria: Data will be shared with researchers who provide a methodologically sound proposal. The type of analyses are defined by the aims in the approved proposal. Proposals may be submitted up to 36 months following article publication. Proposals should be directed to katbec@rm.dk. To gain access, data requestors will need to sign a data access agreement. After 36 months the data will be available in a data warehouse but without investigator support.

Locations

DK (1)