Clinical trial NCT04830605: Feasibility Test of the Treatment Program iACT-by Proxy - a Single Case Experimental Design
Official title: Feasibility Test of the Treatment Program iACT-by Proxy - a Single Case Experimental Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety State
Anxiety Disorders
Keywords: Internet-based treatment
Single-case experimental design
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: University of Aarhus
First posted: 2021-04-05
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: Background

Health anxiety by proxy 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 abnormal. As a consequence, parents with health anxiety by proxy may repetitively perform bodily inspections of their child or have medicial examinations conducted (1, 2). 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(3).

Research on parents suffering from health anxiety has found evidence of health anxiety symptoms being transmitted from parent to child (4, 5) indicating that the parent's response to the child's health complaints (6) and how the parent copes with own symptoms may influence the health attitudes and behaviors of the child(7-10). This risk may be especially high if the parent suffers from health anxiety by proxy because the child is exposed to a particular preoccupation with and fear of illness and symptoms. For these reasons health anxiety by proxy is an important but neglected clinical phenomenon. Therefore, it is important to develop and test treatment targeting health anxiety by proxy.

Internet-based treatment is a relatively new approach that compares favourably with face-to-face treatment (15, 16). The Research Clinic for Functional Disorders and Psychosomatics (Research Clinic), Aarhus University Hospital (AUH) has recently developed an internet-based treatment program (iACT) for health anxiety based on principles from Acceptance and Commitment Therapy (ACT)(17). This treatment has shown promising results (14, 18) and is used as a template for the development of specialised treatment for parents with health anxiety by proxy. The treatment is called iACT-by proxy and is targeting parents' maladaptive anxiety-driven behaviour towards their child with focus on exposure therapy in the context of ACT principles.

The aim of the study is to test the feasibility and possible effect of the iACT- by proxy treatment program for health anxiety by proxy using a single-case experimental design.

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.

Criteria for success of feasibility

* The treatment modules will be well received by the patients regarding format, length, content and contact to the therapist as measured by patient self-report on selected questions and with semi-structured interviews.
* Patients will log in to the modules on a weekly basis and will complete at least 6 out of 8 modules in the treatment. A module is complete when all text has been read in the module and corresponding exercises have been performed.
* Self-reported negative effects of participating are low.

Method

Participants and recruitment

The patients apply for participation in the project through the webpage www.helbredsangst.dk using NemID. On the webpage the patient will find information about health anxiety by proxy and the research project.

When logging in the participant is met with written information about participation and a following statement of consent giving permission to the health professionals in the project to directly collect health information from the patient record and use questionnaire data for research purposes in anonymised form. NemID is accepted as a digital signature by the Data Protection Agency. After the statement of consent, the participant is redirected to a questionnaire about physical and psychological symptoms, and personal background information. If the questionnaire is complete and the consent is signed the participant is self-referred. The participant will be invited to a video-assessment through e-boks.

Assessment

All participants are assessed using a shorter standardised diagnostic interview based on SCAN (Schedules for Clinical Assessment in Neuropsychiatry (21)) and supplemented with assessment of health anxiety by proxy using the HAPYS. The passed information from the patient record concerning the patients' somatic and psychiatric health information is necessary supplementary information for conducting a thorough assessment.

The interview is conducted using an encrypted link for a video-service hosted by the Central Denmark Region (rooms.rm.dk) which comply with the General Data Protection Regulation (GDPR). At the beginning of the interview, the health-professional ensures that the interview will be uninterrupted. The participant can have lay representative present during the interview if preferred.

Informed consent

All participants receive written and verbal information about the project. The participants receive the written information at self-referral. Verbal information is given by the health-professional performing the diagnostic assessment at the Research Clinic, AUH. They sign two consents; one when they complete the self-referral before the diagnostic interview, which gives the responsible investigators direct access to collect information from the electronic patient record for the purpose of using the participant's health information; and one consent when entering the research project after the diagnostic assessment.

Signing the final consent the participants enters the project, gives permission to publish the research data, and gives permission to being contacted during the study period. In order to uphold the treatment responsibility, the participant provides a phone number of a relative in case of suicide suspicion. The system allows the participant to log out and log in again at a later time providing the participant with the opportunity to reflect before signing the consent. If the consent is not signed within two weeks after the interview the participant will be excluded from the study.

Design

The single-case experimental study will be designed with multiple baselines comparing the individuals' baseline level of health anxiety by proxy with the level of health anxiety by proxy during and following participation in the treatment (19, 22). In a multiple baseline design, the participants have different baseline lengths but the same intervention and follow-up period. The baseline and intervention period serves as two study conditions, a control (baseline) and a treatment condition (intervention) with N equally spaced measurement occasions(19). The base-line 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.

Measurements

All measures are self-report measures obtained through the secure web-based software platform for data collection REDCap (Research Electronic Data Capture)(23, 24) hosted at Aarhus University.

Assessment

* Short version of Schedules for Clinical Assessment in Neuropsychiatry (20, 21)
* The Health Anxiety by Proxy Scale (HAPYS) (Ingeman et al., submitted)

Primary outcome

The target measures of health anxiety by proxy are answered though a link in a SMS to the participants every other day from start of baseline to end of follow-up. The order of the items will be random each day. The target measures contain items of core characteristics of health anxiety by proxy which have been selected from the HAPYS based on the following:

Secondary outcome

Standardised self-report questionnaires will be answered four times during the study period (before baseline, right before treatment entry (end of baseline), end of treatment, and at 4-weeks follow-up.

Feasibility outcome

Participants are asked to provide feedback on format, length and content of the treatment program as well as on the contact to the therapist after each treatment-module and in a semi-structured phone-interview with the Ph.D.-student after treatment end.

Intervention

The treatment is an eight-week therapist-supported internet-based program based on written psychoeducation, audio-files, behavioural exposure exercises, homework and videos distributed in eight short modules.

Data analysis

Analysis will be divided into primary outcome and secondary outcome. The primary outcome will be analysed using visual analysis of plotting data and observing if the measures decreases at time of intervention entry (19). Further, using a Bayesian analysis of clinically significant change will quantify the evidence for the size and presence of an intervention effect (35, 36). The secondary outcome is analysed by determining Jacobsen's Reliable Change Index and from this determine that the change seen is not at result of measurement error and whether it is clinically significant(19, 37). The online free-text-answers and the interview on formalities and contact to therapist will be explored using thematic analysis focusing on all participant-experiences.

Funding

The Ph.D.-student and the Department of Child and Adolescent Psychiatry has initiated the research project in collaboration with the Research Clinic, AUH and received funding from numerous funds.

Ethics

The project is conducted in accordance to the rules in the Helsinki-Declaration. The project is registered under the Central Denmark Region's records of research projects (Den interne fortegnelse over forskningsprojekter ved Region Midt; 1-16-02-921-17).

There is no previous research data suggesting that internet-based treatment for health anxiety, anxiety or depression are associated with any form of risk (12, 14-16, 18).

Data protection

All information concerning the participants is protected by the data protection act and the data protection regulation. All personal data including name, telephone number and social security number is encrypted. The questionnaires are not personally identifiable, but have a random ID-number. The participants provide written informed consent to publish data in a single-case format where each participant's data is reported separately, but anonymized.

The platform hosting the treatment program was developed and programmed at the Research Clinic for Functional Disorders and Psychosomatics. All access to the server goes through an encrypted SSL-connection, and data pooling is being logged with IP and user-ID. NemID is used to log in to the platform. Access to the questionnaire data is only granted to researchers in the project and the data will be kept anonymously after project-end.

Project group

The project is conducted at the Research Clinic in collaboration with the Department of Child and Adolescent Psychiatry, AUH.

The project group consist of Katrine Ingeman Beck, psychologist (PhD student)1,2, Charlotte Ulrikka Rask, MD, professor, PhD1,2 (Main supervisor); Lisbeth Frostholm, head psychologist, associate professor, PhD3,2 (Co-supervisor); Kristi Wright, psychologist, associate professor, PhD4 (Co-supervisor); Ditte Hoffmann Jensen, psychologist, PhD3 (Co-supervisor).

1. Department of Child and Adolescent Psychiatry, AUH, Psychiatry, Aarhus, Denmark.
2. Department of Clinical Medicine, Aarhus University, Denmark
3. The Research Clinic, AUH, Aarhus, Denmark.
4. Department of Psychology, Faculty of Arts, University of Regina, Canada.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: SMS-data
timeFrame: Up to 15 weeks
Secondary outcomes:
measure: The health anxiety by proxy scale
timeFrame: Baseline, 1-3 weeks, 9-11 weeks, 13-15 weeks
measure: The Adult Response to Children's Symptoms (ARCS) - parent form (revised)
timeFrame: Baseline, 1-3 weeks, 9-11 weeks, 13-15 weeks
measure: Pain Catastrophizing Scale - parent version
timeFrame: Baseline, 1-3 weeks, 9-11 weeks, 13-15 weeks
measure: The Whiteley-6 Index
timeFrame: Baseline, 1-3 weeks, 9-11 weeks, 13-15 weeks
measure: SCL-8 (emotional distress)
timeFrame: Baseline, 1-3 weeks, 9-11 weeks, 13-15 weeks
measure: WHO-5 Well-Being Index
timeFrame: Baseline, 1-3 weeks, 9-11 weeks, 13-15 weeks
measure: Experience of Service Questionnaire
timeFrame: 13-15 weeks
measure: The Negative Effects Questionnaire
timeFrame: 13-15 weeks
measure: Internet Evaluation and Utility Questionnaire
timeFrame: 13-15 weeks
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University hospital
state: Region Midt
Study officials:
affiliation: Aarhus University Hospital
name: Charlotte Ulrikka Rask, Med.Dr
role: STUDY_CHAIR
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