A pilot study of digital screening and management (multidisciplinary team or online therapy) of health anxiety in medical clinics

doi:10.21203/rs.3.rs-4458107/v1

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Research Article

A pilot study of digital screening and management (multidisciplinary team or online therapy) of health anxiety in medical clinics

https://doi.org/10.21203/rs.3.rs-4458107/v1

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Background DSM-5 introduced illness anxiety disorder and somatic symptom disorder, which commonly fall under the term health anxiety (HA). HA is clinically significant worry about health. The prevalence of HA is higher in general hospital (medical) clinics than in the community.

Firstly, there are limited studies on the proactive identification (screening) of HA in medical clinics. Secondly, there is little understanding of the treatment preferences, if any, of those living with HA attending such clinics. Much of the literature on the management of HA in the medical setting is extrapolated from patients in the community setting. Some patients do not benefit from, nor wish to undertake, the main interventions of psychotherapy and/or pharmacotherapy. There is little literature on a team-based management strategy.

Objectives Firstly, to understand the acceptability of digital screening in patients attending medical clinics; and to assess its feasibility in identifying patients with HA in medical clinics. Secondly, to evaluates the preference, uptake, and initial outcomes of two different management options; a collaborative multidisciplinary team (MDT) approach offering exercise and social work in addition to the traditional interventions; or a clinician guided internet cognitive behavioural therapy (iCBT) course. The outcomes of both parts may allow better understanding for any future randomised trial.

Methods The pilot study was designed with lived experience advisors. Firstly, digital screening in four medical clinics was undertaken using a measure for HA (Whitely Index-6 (WI-6) and a measure for general anxiety. Those with WI-6 ≥18 (likely HA) were invited to partake in treatment (MDT or iCBT). MDT participants underwent diagnostic interviews. Pre-post measures were undertaken.

Results 422/4,040 completed screening (10.4%), of which 160 (37.9%) scored WI-6 ≥18. 124 (77.5%) initially agreed to further contact, yet only 52 (41.9%) completed further consent to partake in treatment. Of those, 39 chose MDT with 24 (61%) of those receiving a confirmatory HA diagnosis. 8 chose iCBT, with 50% completing the course. Participants who sought treatment had significant symptom burden with an average 2.7 chronic medical illnesses, comorbid general anxiety and depression, and high levels of social and personality dysfunction. Pilot pre-post MDT results showed significant reduction on measures of HA, generalised anxiety, depression, and frequency of doctor visits.

Conclusion HA digital screening in hospital clinics is feasible and acceptable and could be used again for trial recruitment. The high drop off rate of engagement warrants further consideration. Approximately half of those identified with clinical HA symptoms wish to engage in management, of which most prefer MDT (including exercise and social work) over iCBT. Despite complex health and social needs, MDT management showed benefits to patients and likely to the hospital. Due to preference and a possible early trends, further research should focus on MDT management.

The trial was registered on the Australian New Zealand Clinical Trials Registry (ANZCTR), number ACTRN12621001023842. Registered 05 August 2021, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=382131&isReview=true

health anxiety

screening

medical clinic hospital outpatient

multidisciplinary

1) What uncertainties existed regarding the feasibility?

- Mental health digital screening is increasingly common and acceptable in many settings (e.g., depression screening in perinatal setting, cancer care). Little is known about digital screening for mental health conditions in patients attending generalist physical health clinics. Is digital screening feasible (i.e., can we set it up locally) and acceptable (will patients complete it)?

- Clinically, many patients with physical health problems are avoidant to address anxiety problems. So, if patients did complete screening and scored highly on health anxiety measures, are the intervention pathways feasible? And once engaged would the pathways be acceptable?

2) What are the key feasibility findings?

- Digital screening was feasible and acceptable. Consent did not cause barriers to engagement.

- The offering of a multidisciplinary team was preferred by the majority of patients and deemed more acceptable than a self-management strategy.

- There were no markers for why patients chose to engage, or not, with the study interventions.

3) What are the implications of the feasibility findings for the design of the main study?

- The acceptability of the digital screening and its relative low cost is promising. It would allow for a scaled-up research trial.

- Thereafter a full randomised controlled trial is warranted; however the specific arms (MDT vs waitlist/ control, MDT vs iCBT, other) is not clear.

- Further engagement with patients, and lived experience participants, is warranted.

Illness Anxiety Disorder (IAD) and Somatic Symptom Disorder (SSD) were introduced to allow easier conceptualization of patients’ concerns and reduce perceived stigma of older terms (e.g., hypochondriasis). IAD is a “disorder of anxiety about having or developing a serious illness”¹. The key features of SSD are “One or more somatic symptoms that are distressing or result in significant disruption of daily life”^2,3. Health anxiety (HA) is an term used to refer to “individuals with an elevated and clinically significant level of worry about health or the presence of disease, regardless of the diagnostic criteria applied”⁴ under which IAD and SSD are grouped. There is wide variation in the reported community prevalence of HA, with a systematic review reporting a range of 2.1%-13.1% in the general population⁵.

Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) clarifies that a patient can have a physical cause for the symptom and meet the criteria for these disorders when the symptoms are in excess of (IAD) and disproportionate to (SSD) what would be expected from their clinical presentation; allowing better understanding of such disorders in patients living with a physical illness (e.g., arthritis). HA is more prevalent in hospital medical clinics, with the CHAMP study (Cognitive behaviour therapy for Health Anxiety in Medical Patients) showing overall prevalence 19.8% on a self-report screening measure [range endocrinology (17.5%) to neurology (24.7%)]⁶. Similarly, Lebel⁷ notes high prevalence of clinical levels of fears (> 20%) across those living with chronic diseases. HA causes immense distress for patients, care-givers and clinicians⁸ and is associated with increased financial costs to services. Primary care patients with high HA (a) use increased resources in the year before, and the year after, identification on screening⁹ and (b) have increased overall health care utilisation, relative to those with low HA¹⁰. Higher rates of health worries lead to higher medical costs, even when correcting for psychiatric and medical comorbidities^9,11.

Treatment for HA is available in primary care and for those attending medical clinics. Psychological treatments are effective and well-tolerated for HA. In primary care¹ the main focus is on Cognitive Behavioural Therapy (CBT)^12,13, and internet-delivered CBT (iCBT) is also effective^{14,15, 16}. The CHAMP trial evaluated CBT for HA (CBT-HA) in a hospital outpatient (medical clinic) setting¹⁷. At 1-year follow-up, significant improvement in HA measures occurred in the CBT group, with a doubling in the number of patients that returned to a normal level of worries in the CBT group, vs control group. Further analysis noted sustained improvement at 2 years¹⁸. Two separate trials^19,20 show some improvements with structured therapy, vs waitlist, in patients attending specialist clinics. Pharmacotherapy can be considered for HA in cases of (a) patient preference, (b) CBT non-responders, or in (c) combination treatment. The evidence supports first line use of Selective Serotonin Reuptake Inhibitors (SSRIs)²¹. Combination (joint) treatment was evaluated in a 2017 USA RCT³ for DSM-IV Hypochondriasis (n = 195; combination treatment [CBT + SSRI(fluoxetine), vs CBT, vs SSRI, vs placebo] that found statistically significant differences in response rates: joint treatment (47.2%), single arm (41.8%, SSRI/ CBT), placebo treatment 29.6%). However, Fallon³ et al. noted that approximately 50% of patients with hypochondriasis did not respond to either CBT or SSRI in their trial and so “more intensive approaches are needed”.

Other less researched interventions exist that warrant exploration. Interdisciplinary communication/correspondence, i.e. medical specialist communication to primary care physicians and/or the patient is helpful^22,23. Communication may outline harm minimisation strategies (e.g., avoiding repeat investigations). Exercise has increasing evidence in managing general anxiety^24,25. Graded exercise therapy (GET) is a therapeutic in the management of chronic fatigue syndrome²⁶, a disorder with high co-morbidity for psychosomatic and anxiety disorders. Social intervention evidence shows benefit is commonly reported by patients with complex needs²⁷ when they engage with social workers. The CHAMP¹⁷ study identified high levels of social dysfunction in patients with HA attending hospital, and so such interventions may provide benefit to this patient group.

Rationale for the study

Firstly, to understand the acceptability of digital screening in patients attending medical clinics; and to assess its feasibility in identifying ‘real-world’ patients with HA in medical clinics.

i.e., Is digital screening acceptable patients?

Does digital screening identify patients with HA?

Secondly, to evaluates the preference, uptake, and initial outcomes of two different management options; a collaborative multidisciplinary team (MDT) approach offering exercise and social work in addition to the traditional interventions; or a clinician guided internet cognitive behavioural therapy (iCBT) course.

i.e., Do patients with HA in a medical setting wish to seek treatment?

If so, what is acceptable to them?

The outcomes of both parts may allow better understanding for any future randomised trial.

Trial design

The pilot study was set-up with two consecutive parts; the first identifying people with possible HA, and the second to engage patients with possible HA and offer them treatment.

There was neither randomization nor an allocation ratio. There were no changes to the protocol, nor to the inclusion/ exclusion criteria across the running of the trial.

No predefined statistical sample size was calculated. Instead a target of offering all attendees across a 12-month period access to the screening was planned. Based on prior years this would reach approximately 5,000.

Part 1: Digital (online) screening

The inclusion criteria: adult (≥ 18yo), attendees at identified medical clinics (dermatology, rheumatology, endocrinology, and Upper GI surgery). The main exclusion criterion was participation in screening in the past 6 months (to avoid duplicate screening).

Clinic attendees were invited via a ‘Standardised Messaging Service’ (SMS) to complete screening questionnaires for anxiety. This is called a ‘cold-contact’ text or ‘cold-text’ as the person has not actively agreed, or is unaware, of the upcoming SMS. Cold-text appointment reminders were already hospital practice. Attendees that wished to partake in screening completed an online consent form (Consent 1) which could be done on a smart phone, tablet, or a laptop. Participants then completed two online questionnaires (health and generalised anxiety), basic demographic information and gave contact details. Standardised emails were sent to all participants explaining their scores with links to appropriate resources. The system was stratified such that the response and recommended resources were tailored according to severity of symptoms. Anyone with an elevated HA score was additionally sent a link to a video and e-literature explaining the interventions. Participants were asked whether they were agreeable to further contact.

Part 2: Selection and engagement with the study interventions

The Inclusion criteria: completion of online screening process, elevated HA scores and agreement to ongoing contact. Participants were offered further communication (phone and/or email), and asked to complete a second electronic informed consent (Consent 2). Participants were then registered as patients of the public mental health service (MHS). Clinical care was managed respecting the policies and clinical governance of both the research and MHS institutions.

Participants could choose either trial intervention (iCBT, or the multi-disciplinary team (MDT)). There were no further inclusion or exclusion criteria for the iCBT group. To continue in the MDT pathway, the participant needed a confirmed diagnosis of IAD or SSD.

iCBT

This self-management, low-intensity, intervention could be accessed at a time convenient for the participant. This pathway had free access to a proven HA iCBT course¹⁵. The program has 6-lessons, generally taking 12-weeks. Clinician guidance was provided, as a systematic review of 29 articles²⁸ strongly concludes that “Without health professionals’ support, many people will not access web-based therapies”. This group received intake questionnaires only as shorter online questionaries reduce attrition²⁹.

MDT

The MDT allowed inter-disciplinary management. Strategies considered included psychology, pharmacotherapy, exercise physiology and social work. The initial assessment was undertaken by two clinicians and incorporated a structured diagnostic interview, the Anxiety and related Disorder Interview Schedule for DSM-5³⁰ (ADIS). The specific ADIS modules were 1. IAD, 2. SSD, 3. Major Depressive Disorder (MDD), 4. Generalised Anxiety Disorder (GAD). If either IAD/SSD were confirmed, the patient became eligible, and a collaborative management plan was developed. Progress and engagement were followed at fortnightly team meetings. Participants undertook repeat measures at 6, 12 and 24 weeks. Electronic medical records were kept. Correspondence was sent to the medical clinic physician for all patients who enrolled in the intervention part of the study.

Lived experience involvement in study design

The study interventions were collaboratively designed by members of the authorship group in consultation with a Lived Experience Panel (a small group of people with a lived experience of HA, who were reimbursed). They offered advice, reviewed material, and offered insight into potential barriers.

Measures used

Online screening measures

The health anxiety measure was the “Whiteley Index–6, 6-items. (WI-6)³¹. The range is 6–30, with a cut-off score of 18 used (balances sensitivity (75%)/specificity (77%)³²) to indicate caseness.

The generalised anxiety measure was the “Generalised Anxiety Disorder Assessment, 7-items (GAD-7)³³. The range is 0–21. The recommended cut off for the GAD-7 severity index is ≥ 10.

MDT pathway self-report measures

Somatic concerns: The Patient Health Questionnaire, 15 items (PHQ-15)³⁴, used to assess somatic symptoms. Range is 0–30 and scores of ≥ 5, ≥10, ≥ 15 represent mild, moderate, and severe levels of somatic symptoms.

Social functioning: The Social Functioning Questionnaire (SFQ)²⁷, 8-item scale, used to assess perceived social-functioning. Range is 0–24. General population mean is 4.6 (with only 10% scoring ≥ 10); General practice attendees mean is 7.7; people with a psychiatric emergencies mean is 11.4²⁷.

Quality of Life: The European Quality of Life Five Dimension (EQ-5D 5L) questionnaire³⁵, a standardised health-related quality of life measure. Each question ranges from 1–5, 1 indicating no problems, 5 indicating extreme problems/inability to do tasks. Questions assess mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, respectively.

Personality factors: The Structured Assessment of Personality Abbreviated Scale (SAPAS)³⁶, 8-items. Range is 0–8. Personality screening with a score of ≥ 3 indicating the likely presence of a personality disorder.

Health care utilisation: The Ritter-4. 4 questions asking how many times in the last 6 months did you: 1 see a doctor; 2 attend the emergency room; 3 stay in hospital overnight; and 4 how many total nights did you stay in hospital?

Treatment expectations & satisfaction. Prior to commencement: The Credibility/Expectancy Questionnaire (CEQ)³⁷, participants were asked to rate on a scale of 1–9; 1. how logical and 2. how successful they thought the treatment would be. At the end of intervention: abbreviated version of the Treatment Satisfaction Questionnaire (TSQ)³⁸. Participants were asked to rate on a scale of 1–9; their satisfaction that the program taught them the skills to manage their health anxiety and their confidence in recommending the program to a friend with similar problems.

Measurable outcomes

This is a pilot study.

Aim 1 is to examine the feasibility, and uptake of digital screening in medical clinics. A measurable outcome will be the completed response rate. The overall scores from WI-6 & GAD-7 will be reported. A comparison between clinic differences on both update and measures (chi-square test of independence) was planned.

Aim 2 is to examine the acceptability and uptake of different interventions in the medical clinics. Measurable outcomes are the participant preference for interventions (and assessing intergroup differences by age, WI-6, GAD-7 scores etc. An Analysis of variance (ANOVA)] looking for proxy indicators of choice e.g., age, or severity of elevated anxiety leading towards a certain preference). Patient satisfaction measures at the end (TSQ) will be recorded. A pre – post (i.e., initial time point to 24 weeks) analysis (Paired sample t-tests) will be undertaken to determine any effect of MDT treatment on WI-6, GAD-7, PHQ-9, PHQ-15, SFQ, EQ-5D 5L and the Ritter-4.

There was not change to either the assessments nor the measurements across the running of the trial.

Part 1: Online screening

See “Figure 1: Flow chart overview from screening to completed interventions”.

Overall

4,040 confirmed initial SMSs were sent to individual attendees across a 12-month period (June 2020 to June 2021). There was monthly variation on the number of attendees across this time (range 94–538 per month) due to COVID-19 logistical changes. Repeat SMS to the same attendee (e.g., follow-on attendance) are not reported as the attendee was not asked to repeat the survey.

Acceptability of screening

422 (10.4%) of all recipients completed both questionnaires fully. The response range varied according to the medical clinic. Outpatients from Rheumatology (49/553 = 8.9%) and Upper GI (68/820 = 8.3%) surgery were significantly less likely to complete online mental health screening compared to outpatients from the Endocrinology (193/1880 = 10.3%) and Dermatology (112/787 = 14.2%) clinics (X²(3) = 31.662, p < .001).

See “Table 1. Screening outcomes and acceptance rates as per medical clinic”

Table 1

Screening outcomes as per medical clinic
	Part 1: Online screening				Part 2: Seek intervention
Clinic	SMSs delivered	Completed screening N (%)*	High HA N (%)	No GAD N (%) GAD N (%)	Agreeable to contact N (%)
Endocrinology	1880	193 (10.3)	76 (39.4)	50 (65.8) 26 (34.2)	63 (82.9)
Dermatology	787	112 (14.2)	43 (38.4)	32 (74.4) 11 (25.6)	31 (72.1)
Upper GI Surgery	820	68 (8.3)	20 (29.4)	17 (85.0) 3 (15.0)	16 (80.0)
Rheumatology	553	49 (8.9)	21 (42.9)	14 (66.7) 7 (33.3)	14 (66.7)
Total	4040	422 (10.4)	160 (37.9)	113 (70.6) 47 (29.4)	124 (77.5)
*A chi-square test of independence was performed to evaluate the relationship between medical clinic and online screening. The relationship between these variables was significant, X²(3) = 31.662, p < 0.001. Outpatients from Rheumatology and Upper GI surgery were less likely to complete online mental health screening compared to outpatients from the Endocrinology and Dermatology clinics. HA, Health Anxiety; GAD, Generalised Anxiety Disorder; GI, Gastrointestinal; SMS, Short Message Service

Results of screening

160 (37.9%) of those screened had high measures of HA. The majority of those (n = 113, 71%) had only high health anxiety scores, with only 47 (29.4%) having elevated levels of generalised anxiety. There was no significant difference between clinic type on either WI-6 (F(3,418) = 1.607, p = 0.187, ηp² = 0.011) or GAD-7 (F(3,418) = 0.283, p = 0.838, ηp² = 0.002) scores.

Further contact the majority (n = 124, 77.5%) of respondents with high HA were agreeable to further contact.

Part 2: Study interventions

The 124 respondents with High HA (≥ 18 WI-6) agreeable to further contact received team communication. From those people, 52 (41.9%) participants went on to complete the second consent and indicate a preferred pathway.

See “Table 2. Study participants: demographics, self-report measures, and clinical interview outcome”.

Table 2. Study participants: demographics, self-report measures, and clinical interview outcome

	Intervention pathway
Characteristic/Variable	All (N = 47)	iCBT (N = 8)	MDT (N = 24)	Ineligible (N = 15)	Significance test
Demographics
Age (yrs.)	52.0 (16.6)	54.0 (18.3)	48.2 (16.2)	57.2 (15.8)	p = .242
Female n (%)	34 (72.3)	6 (75.0)	19 (79.2)	9 (60.0)	X²(2) = 1.729, p = .421
Self-report intake measures
WI-6	23.9 (4.1)	23.9 (3.9)	24.9 (4.2)	22.3 (3.7)	p = .153
GAD-7	10.8 (5.4)	12.8 (5.1)	11.1 (4.9)	9.3 (6.1)	p = .333
PHQ-9	13.5 (5.6)	16.1 (4.3)	13.7 (4.3)	11.7 (7.4)	p = .193
PHQ-15	13.5 (4.8)^#	14.8 (4.6)	13.9 (4.4)	12.2 (5.6)	p = .434
SFQ	10.5 (4.3)	11.9 (2.9)	10.9 (3.5)	8.9 (5.7)	p = .225
EQ-5D^##	49.2 (21.5)	48.8 (20.1)	49.9 (19.2)	48.3 (26.6)	p = .974
SAPAS	3.9 (1.9)	4.5 (1.9)	4.0 (1.7)	3.5 (2.2)	p = .440
Ritter-1	12.6 (12.1)	11.0 (12.2)	14.5 (13.3)	10.5 (12.1)	p = .566
CEQ-Logic^###	6.9 (2.2)	6.1 (2.4)	8.0 (1.3)	5.5 (2.5)	p = .001*
CEQ-Success	6.2 (2.1)	5.4 (2.1)	6.8 (1.9)	5.6 (2.1)	p = .084
Clinical interview outcome
MH factors n (%)^####
IAD		No interview	15 (62.5)	No HA on
SSD		undertaken	17 (70.8)	Interview
GAD			18 (75.0)	5 (33.3)	X²(1) = 6.624, p = .010*
MDD			4 (16.7)	2 (13.3)	X²(1) = 0.079, p = .779
MH Medications			0.63 (0.8); 0–2	0.73 (1.2); 0–3	X²(1) = 0.596, p = .440
Current MHC n (%)			9 (37.5)	2 (13.3)	X²(1) = 2.662, p = .103
Prior admissions n (%)			6 (25.0)	5 (33.3)	X²(1) = 0.317, p = .574
Prior therapy n (%)			22 (92.7)	7 (46.7)	X²(1) = 9.804, p = .002*
Prior MDE n (%)			5 (20.8)	5 (33.3)	X²(1) = 0.756, p = .384
Physical health factors
Chronic illness/es			2.7 (1.8); 0–9	3.4 (2.3); 1–10	X²(1) = 0.013, p = .908
Medications (not MH/PRN)			2.7 (2.1); 0–7	3.9 (3.3); 0–11	X²(1) = 1.242, p = .265
Demographics summary
Married/De facto n (%)			11 (45.8)	7 (46.7)	X²(1) = 0.003, p = .959
Employed n (%)			13 (54.2)	5 (33.3)	X²(1) = 2.077, p = .150
Born in Australia n (%)			16 (66.7)	8 (53.3)	X²(1) = 0.693, p = .405
ATSI n (%)			0 (0.0)	1 (6.7)	X²(1) = 1.642, p = .200
^#Note missing data for 2 MDT (Multi-Disciplinary Treatment) and 2 Excluded participants. ^##Patients scores from overall health rating scale. ^### Note the F statistic is presented in the table, follow up independent T-Tests in the text. ^####Some participants had co-morbid presentations of multiple disorders. *Statistically significant. All figures are mean (SD) and range unless stated otherwise. ATSI, Aboriginal and Torres Strait Islanders; CEQ, Credibility and Expectancy Questionnaire, EQ-5D, EuroQol Five-Dimension scale; GAD, Generalised Anxiety Disorder; IAD, Illness Anxiety Disorder; iCBT, Internet Cognitive Behavioural Therapy; MDD, Major Depressive Disorder; MDE, Major Depressive Episode; MH, Mental health; MHC, Mental health care-plan; PHQ, Patient Health Questionnaire; PRN, Pro re nata; SAPAS, Structured Assessment of Personality Abbreviated Scale; SD, Standard deviation; SFQ, Social Functioning Questionnaire; SSD, Somatic Symptom Disorder; WI, Whitely Index.

For all participants in the second part of the study, the majority were female (72.3%), with an average age of 52 years old. The self-report measures showed significantly elevated WI-6 (M = 23.9) and GAD-7 (M = 10.8) scores. There was significant symptom burden overall, with the groups average PHQ-9 = 13.5 (moderate depression), SFQ = 10.5 (significant social dysfunction), SAPAS = 3.9 (indicating likely caseness for a personality disorder), Ritter-Q1 = 12.6 (the average number of doctor attendances in the last 6 months), and EQ-5D = 49.2 (poor quality of life).

Three sub-groups arose from that cohort (i.e., those who chose iCBT, those who chose the MDT and were eligible on interview, and those that chose the MDT but were then ineligible i.e., iCBT, MDT, Ineligible). The only significant differences on self-report measures between the three groups was on CEQ-Logic (F(2, 44) = 7.834, p = 0.001, ηp² = 0.263) with follow up T-tests revealed MDT participants were more likely to view the treatment as logical compared to non-MDT patients (t(37) = 3.470, p = 0.003). There were no other differences between the three sub-groups.

A small number (n = 8, 15%) chose iCBT. Most participants (n = 44, 85%) chose the MDT with 5 not completing the formal assessment process for several reasons [abrupt cessation of contact (n = 3), medical hospitalisation (n = 1) and a natural death unrelated to the study (n = 1)].

In those who chose the MDT and completed the full assessment (n = 39), 24 (61%) had a confirmed diagnosis of HA. Fifteen people were ineligible at the time of clinical assessment as they did not have a HA diagnosis. Instead, their reported high HA was attributed to: (a) resolved anxiety regarding an appointment or medical result (n = 4), (b) GAD (n = 4), (c) subthreshold HA (n = 4), (d) neurocognitive disorders (n = 2), (e) neurodevelopmental disorders (n = 2).

The MDT interview showed high psychiatric co-morbidity and physical health burden. Of the eligible HA participants, 75.0% had co-morbid GAD, with 16.7% having MDD. Over half were taking at least one psychotropic medication, and a quarter previously having a psychiatric admission. 37.5% of eligible participants were currently engaging with a mental health clinician and the vast majority (92.7%) had prior psychological therapy at some point in their life. There was high physical health burden with the average patient in the eligible group having 2.7 confirmed chronic medical illnesses (range 0–9) and taking an average 2.7 (0–7) physical health medications. 66% of the MDT participants were born in Australia, with 45.8% in a married or de facto relationship, and 54.2% in some form of employment.

After undergoing the clinical assessment for eligibility for the MDT pathway, those that were confirmed to have HA were significantly more likely to receive a co-morbid GAD diagnosis at intake interview X²(1) = 6.624, p = 0.010; and have had previous MH therapy X²(1) = 9.804, p = 0.002.

Engagement in iCBT

A large variation in participation occurred in the eight participants in iCBT with 25% never starting the course and 50% completing all 6 of the lessons.

Engagement in the Multi-Disciplinary Team (MDT)

The vast majority (n = 21/24, 87.5%) of participants in the MDT were recommended to have a form of psychological therapy as part of their collaborative treatment plan. The psychotherapy modality was individualised³⁹ and included face-to-face therapy, iCBT alone, or iCBT as blended care. The vast majority availed of at least one other intervention [Exercise physiology (n = 12), Social Work (n = 13) and medication initiation (n = 5)].

See “Figure 2: Multi-Disciplinary Team patients pre-post self-report measures”.

75% (18/24) of participants in the MDT clinic completed all repeat outcome measures. The pre-post MDT results show significant differences: decrease in WI-6 scores [pre:(M = 24.67; SD = 4.16) to post:(M = 18.83;SD = 6.12); t(17) = 3.87, p = 0.001], decrease in GAD-7 [pre:(M = 10.61; SD = 4.47) to post:(M = 7.06; SD = 4.93); t(17) = 2.64, p = 0.017], and decrease in PHQ-9 [pre:(M = 14.33; SD = 4.35) to post:(M = 9.33; SD = 5.85); t(17) = 3.66, p = 0.002]. There was a significant reduction in the number of doctor visits in the prior 6 months (Ritter-1, Q1) [pre:(M = 15.67; SD = 14.741) to post:(M = 9.94; SD = 8.842); t(17) = 2.703, p = 0.015]. There were no statistically significant pre-post changes results on the remaining pre-post measures of PHQ-15, SFQ, EQ-5D 5L or the remaining questions on the Ritter-4.

Other results: Patient satisfaction measure

For the n = 22 who completed the final questionnaires of the MDT, the TSQ showed on average good satisfaction (6.73, SD = 2.0, range 1–9) and high confidence to recommend to another (7.41, SD = 2.1, range 1–9).

Other results: harms/ unintended effects

There was a single formal complaint regarding the use of cold-text. There were no significant safety issues nor any clinical matters warranting the completion of a (serious) adverse event outcome. The reported death was unrelated to the study.

Other results: Data Linkage

Patient consent was obtained at Consent-1 to allow data linkage analysis regarding the health care utilised in the years preceding and prospectively from the time of engagement. This will be analysed in future research.

This pilot study assesses the feasibility and uptake of digital screening for anxiety and HA in medical clinics. It then explores the engagement of patients in treatment for HA.

Digital (online) screening

The completed screening rate of two mental health surveys is promising and shows acceptability. Two health-related cold-texts studies showed similar response rates^40,41 and it is higher than the response rates that occur in non-clinical cold-texts samples⁴². The completion rates are especially promising given the study consent process, and that the study coincided with media reports on scam SMS’s⁴³. The significant variation in response rate by these four specialities, and yet a similar rate of high HA in the respondents, is not understood. The CHAMP study methodology used a different measure, the Short Health Anxiety Inventory⁶, and assessed all attendees via a paper form in person. They subsequently found variability within specialties in their work⁶. Regardless of the process, the elevated rates of HA across each medical clinics are, as expected, higher than in the general population and of that in general practice. This was a low cost manner of screening in our local university teaching hospital setting.

Consideration for future research

These findings indicate that digital screening was feasible in our local health district and hospital. It was relatively inexpensive (vs face-to-face screening) and a good way to start cross disciplinary research i.e., a mental health topic in the medical clinic. This form of engagement was acceptable for patients attending medical clinics. Overall, it could be replicated in future research.

Treatment uptake

There was pre-trial expectation that disengagement would occur and an attempt to mitigate attrition was undertaken (e.g., engagement with Lived Experience Advisors). Yet it remained challenging to engage the initial 124 participants with high HA in any treatment pathway. The majority of participants ceased contact without explanation. This may be multifactorial; physical health (e.g., improvement), mental health (e.g., resolution of anxiety), external (e.g., COVID-19 demands), and/or trial (e.g., lack of embedment within the medical clinic) factors.

Both this study and CHAMP show high numbers of medical clinic attendees are needed to engage this “hard to reach”⁴⁴ cohort of patients. In CHAMP there was face-to-face screening (n = 43,205) with randomisation of 444 participants with high HA (1.02%); whereas this study had digital screening (n = 4,040) resulted in identification of 124 participants with high HA (3.07%) but a final engagement of 32 patients (0.79%).

Patients who went on to start treatment

There were no proxy markers to identify (a) the type of patient that would prefer a particular treatment option nor (b) the type of patient with high WI6 scores that would meet the formal diagnostic criteria of IAD or SSD on interview.

The majority of those seeking assistance for HA chose a traditional clinic. Most engaged with psychotherapy in combination with another modality with few availing of pharmacotherapy. The other less researched interventions were well received. Exercise, of varying intensities, was acceptable to patients despite being medically unwell⁴⁵. The role of the social worker was exactly as described by Gehlert including “advocacy, support, and linking to services”⁴⁶ and was acceptable. The pre-post pilot MDT results are promising and are consistent with the benefits identified in the MDT management of chronic pain⁴⁷.

The engagement rates for iCBT were reasonable and, whilst less popular, this option seems appropriate for people who choose it. The course uptake was less than for iCBT use in clinical depression/anxiety management in cancer survivors⁴⁸, and more in keeping with engagement for those with advanced cancer⁴⁹.

Consideration for future research

These findings indicate that a virtual MDT and iCBT were actualised and feasible in the group of patients seeking assistance. The high drop off engagement warrants further evaluation with patients, lived experience participants, experts, and statisticians to design future research. Given the strong preference for MDT and the positive pre-post results, further research should focus on MDT management e.g., in a randomised controlled trial. The specific arms of which (MDT vs waitlist/ control, MDT vs iCBT etc.) warrants consideration.

Limitations

This is a pilot study. The response rate of high HA has a significant sampling bias. The low final numbers who partook in any intervention and the lack of randomisation are also notable limitations. The sample who received care are very specific and so the pilot findings are not generalisable. A replication with a larger sample with randomisation could be considered.

Cost

Research shows that “anxiety disorders and health anxiety are associated with increased healthcare utilization across multiple care settings”⁵⁰. The significant pre-post finding of decreased doctor visits post MDT is hopeful. Digital screening was inexpensive in our local setting, however there are costs in providing MDT clinician time. Future data record linkage research from this group will look to assess health care utilisation in the preceding period with self-reported measures. That may give information on cost effectiveness.

Note that a case report is available to give the reader further insights into the pilot trial. ⁵¹

It is feasible and acceptable to digitally screen patients in medical clinics for HA. Around half the people with clinical range HA symptoms wish to engage in a management plan. The majority prefer an multidisciplinary approach.

Within the MDT, psychotherapy was strongly preferred over pharmacotherapy, and the less traditional interventions of exercise and social work were well received. Despite the patients having complex (physical, psychiatric, personality and social) needs, the early MDT results showed patient benefit and likely benefits to the hospital system as well.

Ethics approval and consent to participate:

Local Health District Human Research Ethics Committee (HREC): 2021/ETH00357

Consent for publication:

“Not applicable”.

Availability of data and material:

The data that support these findings are available from the corresponding author upon reasonable request.

Competing interests:

"The authors declare that they have no competing interests".

Source of Funding:

This project was supported by the Mindgardens Neuroscience Network, which is an Australian not-for-profit research collaboration, through funding provided by the Australian Government Department of Health and Aged Care.

JN is supported by funding from the Australian National Health and Medical Research Council (2008839) and Medical Research Future Fund (1145382).

Authors' contributions:

MJM designed, oversaw the clinical part of the trial, analysed the data, and prepared each draft. BS & KAK were had oversight into the data management and patient follow-through. The prepared data and they reviewed each draft of academic paper. HB, PB & CS provided clinical input into trial patients, participated in case discussions, and reviewed each draft of academic paper. SH, MMil, SS and JN provided clinical and academic oversight respectively to the project, participated in organization governance, reviewed each draft of academic paper.

Acknowledgement:

We would like to thank the hospital teams and support staff for their assistance in realising this project. We are very grateful to the Black Dog Institute lived experience team members for their valuable input throughout the project.

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A pilot study of digital screening and management (multidisciplinary team or online therapy) of health anxiety in medical clinics

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Version 1

Abstract

Figures

Key messages regarding feasibility

Introduction

Methods

Trial design

Part 1: Digital (online) screening

Part 2: Selection and engagement with the study interventions

Online screening measures

MDT pathway self-report measures

Results

Part 1: Online screening

Part 2: Study interventions

Engagement in iCBT

Engagement in the Multi-Disciplinary Team (MDT)

Other results: Patient satisfaction measure

Other results: harms/ unintended effects

Other results: Data Linkage

Discussion

Digital (online) screening

Treatment uptake

Patients who went on to start treatment

Limitations

Cost

Conclusion

Declarations

References

Supplementary Files

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Version 1