A Pilot Randomised Control Trial Exploring the Feasibility and Acceptability of Delivering a Personalised Modular Psychological Intervention for Anxiety Experienced by Autistic Adults: Personalised Anxiety Treatment-Autism (PAT-A)
Auteurs:
Jacqui Rodgers, Samuel Brice, Patrick Welsh, Barry Ingham, Colin Wilson, Gemma Evans, Katie Steele, Emily Cropper, Ann Le Couteur, Mark Freeston, Jeremy R. Parr
Jacqui Rodgers and Samuel Brice are considered co-first authors.
Publisher's Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Anxiety is common for autistic people, with a prevalence rate of 42% for autistic adults (Hollocks et al., 2019). Anxiety limits quality of life (Mason et al., 2019) and impacts on employment and education (Harmuth et al., 2018). Since anxiety may interact with autistic traits (Moore et al., 2021; South & Rodgers, 2017), autistic people may experience anxiety differently (Spain et al., 2017). Autistic people may experience alexithymia (difficulties identifying and describing emotions) (Kinnaird et al., 2019) and have difficulties coping with distress or regulating emotions (Weiss et al., 2014). Identifying these difficulties may guide delivery of more effective psychological therapy (National Autistic Society (NAS), 2021).
Developing effective anxiety interventions for autistic people is a key priority in the United Kingdom (Department of Health, 2014; James Lind Alliance, 2016; National Institute for Health and Care Excellence (NICE), 2012). Cognitive Behavioural Therapy (CBT) is typically the recommended first line treatment for anxiety (NICE, 2011). CBT and mental healthcare require adjustments and adaptations for autistic people (NAS, 2021; NICE, 2012), including for example: a therapist who understands autism; use of technology; use of written and visual material; a more concrete, structured approach; and involving supporters. Clinicians report that ‘autism specific’ adaptations accounted for around 40% of the ‘active ingredients’ that made CBT with autistic people more effective (Spain & Happé, 2020).
There is limited, but promising, evidence for the effectiveness of adapted CBT for autistic adults experiencing anxiety (Spain et al., 2015). A meta-analysis reported CBT to be effective in treating affective disorders (primarily anxiety) experienced by autistic people; however, effect sizes were small to medium (Weston et al., 2016). Adapted CBT has also demonstrated promise in treating phobia experienced by autistic adults (Maskey et al., ). A recent systematic review reported inconsistencies regarding the effectiveness of CBT with autistic adults but proposed that mindfulness-based therapies may be an effective anxiety treatment (Menezes et al., 2022). Additionally, a review of studies reporting on successful CBT interventions with autistic young people concluded such approaches offer more adjustments than those recommended in NICE guidelines (Walters et al., 2016). One important consideration yet to be addressed in the development of psychological therapies for anxiety, is that autistic people are more likely to experience multiple anxiety disorders concurrently (Joshi et al., 2013). Interventions that target one specific anxiety disorder (or anxiety in one specific situation) may thus address only part of an autistic individual’s anxiety experience. Autistic people may therefore benefit from modular approaches which can be used flexibly to offer a personalised intervention, potentially able to address anxiety across multiple contexts.
Anxiety in social situations (Spain et al., 2018) and phobias/situation specific anxiety (Lever & Geurts, 2016) are particularly common for autistic people and there is evidence supporting adapted CBT as an effective treatment for both (Maskey et al., 2019a; Maskey et al., 2019a, 2019b, 2019c, 2019d; Spain et al., 2015). Maskey et al., (2019a, 2019b, 2019c, 2019d) found acceptability and feasibility of using CBT in a virtual reality setting. Research also identified Intolerance of Uncertainty (IU) (Carleton, 2016) as a transdiagnostic factor in anxiety experienced by autistic people (Jenkinson et al., 2020). The Coping with Uncertainty in Everyday Situations (CUES) (Rodgers et al., 2018) psychological therapy was developed for autistic people to address IU and has demonstrated acceptability, feasibility and promising effectiveness. Behavioural interventions, such as mindfulness-based stress reduction, have also demonstrated efficacy in alleviating anxiety symptoms for autistic adults (Gaigg et al., 2020). Finally, the importance of supporting autistic people to develop the requisite skills in understanding and describing emotions has been persistently highlighted as an important modification to improve the efficacy of CBT as a transdiagnostic anxiety treatment for autistic people (Walters et al., 2016).
Thirty-four autistic adults were recruited via NHS clinical teams (adult mental health and adult autism diagnostic services) within Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust. The demographic characteristics of participants are reported in Table 1.
Currently taking medication for a mental health condition N (%)
13 (76.5)
12 (70.1)
Previous experience of psychological therapy for a mental health condition N (%)
14 (82.4)
15 (88.2)
Previous inpatient admission for a mental health condition N (%)
5 (29.4)
4 (23.5)
α = Cronbach’s alpha
*Higher scores indicate greater adaptive functioning, Max = 34
$Range = 1–4, lower scores suggest greater need for adjustments
Eligibility Criteria
Inclusion Criteria
Aged ≥ 18 years; diagnosed as autistic by an NHS clinical team; able to provide informed consent; with the verbal comprehension skills required to participate in interviews, talking therapy and questionnaire completion; and identified as experiencing clinically significant anxiety by an NHS clinician.
Exclusion Criteria
Not meeting the inclusion criteria; receiving current or recent (within three months) psychological therapies for anxiety; experiencing a mental or physical health condition that is likely to significantly affect capacity to engage in PAT-A. Participants were not excluded if they were receiving previous or ongoing pharmacological treatment for anxiety.
Recruitment
Clinicians approached eligible registered NHS patients and those interested returned an expression of interest form to the research team. Potential participants were sent written information by post or email depending on their preference. Those interested had a face-to-face meeting with the clinical research associate (CRA; SB) to discuss the trial, address questions or concerns, screen for eligibility and, if appropriate, proceed to taking written informed consent (participants had one week to consider taking part before deciding about participation).
Anxiety and Related Disorders Interview Schedule for DSM-5: Adult Version (ADIS-5; Brown & Barlow, 2014)
A structured interview designed to identify current anxiety, mood, obsessive–compulsive, psychotic, trauma, and related disorders (e.g., somatic symptoms, substance misuse) according to DSM-5 criteria (American Psychiatric Association (APA), 2013). For each disorder indicated, the interviewer assigns a Clinician Severity Rating (CSR) based on the degree of associated distress and functional impairment. CSR ratings range from 0 to 8 whereby a CSR of ≥ 4 is considered to meet DSM-5 diagnostic threshold.
Personalised Anxiety Interview Schedule-Autism (PAIS-A; Brice et al., In Preparation)
A bespoke form developed for this study and completed by the CRA after completion of baseline assessment and by the therapist after each treatment session. The PATA-SPF was used to identify ways to facilitate the participant’s participation in the assessment/ intervention sessions using five key markers, each rated on a four-point scale: (1) level of verbal communication, (2) focus/attentiveness, (3) understanding of key concepts, (4) ability to flexibly move between topics and (5) speed of processing information. This information was used by the clinical team to inform the provision of any adjustments required to support the participant’s engagement in future sessions.
Additionally, participants completed the following self-report questionnaires to enable characterisation of their autism profile, ability to understand and describe emotions, and adaptive functioning. Where available, outcome measures which have previously demonstrated acceptable psychometric properties for use with autistic adults were selected (see Parr et al., 2020 for full details). The internal consistency (Cronbach’s α) of the following baseline characteristic questionnaires is reported in Table 1.
Social Responsiveness Scale—2nd Edition (SRS-2; Constantino & Gruber, 2012). A standardised self-report questionnaire used to rate the social communication difficulties of autistic adults and children.
Toronto Alexithymia Scale-20 (TAS-20; Bagby et al., 1994): a measure of alexithymia comprising of three subscales: difficulty describing feelings, difficulty identifying feelings, and externally-orientated thinking.
Waisman Activities of Daily Living Scale (W-ADL; Maenner et al., 2013): a measure of adaptive functioning and daily living skills, validated in people with a broad range of developmental disability diagnoses.
Outcome Measures
Anxiety and Other Measures
The following questionnaires were completed by participants at baseline, and at three months post-intervention. The Anxiety Scale for Autism-Adult (ASA-A) and Hospital Anxiety and Depression Scale (HADS) were also completed immediately post-intervention. The internal consistency (Cronbach’s α) of the following outcome questionnaires is reported in Supplementary Table 6.
Anxiety Scale for Autism–Adult (ASA-A; Rodgers et al., 2020). A 20-item self-report questionnaire designed to measure anxiety in autistic adults (consists of a general anxiety factor and three group factors: social phobia, Anxious Arousal and Uncertainty). A total score of ≥ 28 on the ASA-A may indicate clinically significant anxiety.
Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983). A 14-item self-report questionnaire designed to measure symptoms of anxiety and depression.
WHO Quality of Life-BREF (WHOQOL-BREF; World Health Organisation, 1998). A 26-item questionnaire covering four domains of quality of life (Physical health, Psychological health, Social relationships, and Environment). The Disabilities module (Power et al., 2010) and the Autism Addendum (ASQoL; McConachie et al., 2018) were also completed to assess disability-related and autism-related quality of life respectively.
EuroQoL 5 dimensions, 5 levels health survey (EQ-5D-5L; Herdman et al., 2011). A generic measure of health-related quality of life.
Target Situation vignettes. The participant and the CRA jointly agreed two important target situations associated with significant anxiety and impact on everyday functioning and QoL (e.g. going to the supermarket during a busy time). For both situations, a semi-structured interview was undertaken at baseline, 3 month and 12-month follow-up to determine the frequency and degree of anxiety, the participant’s response to the situation (symptoms and behaviour) and impact on daily functioning and QoL for the participant and people close to them. The CRA then summarised the information in a written vignette. All vignettes were anonymised and rated by researchers and clinicians, blind to intervention group. Using a well-recognised procedure with high levels of agreement between expert raters (Arnold et al., 2003; Maskey et al., 2014; Maskey et al., 2019a, 2019b, 2019c, 2019d), pairs of anonymised vignettes from baseline and 3 month follow-up were compared to identify whether there has been any change since baseline using a 9-point scale ranging from ‘very much improved’ to ‘disastrously worse’. Each vignette was rated by four panel members (unaffiliated to the study) independently and the mean score was calculated. The Target Situations interviews were repeated at 12 months post-intervention to investigate feasibility and acceptability.
Clinical Global Impression of Improvement scale (CGI-I; Busner & Targum, 2007). A standardised framework for rating to what extent the participant’s symptoms have improved or worsened on a 7-point scale ranging from ‘very much improved’ to ‘very much worse’. At 3 months post-intervention, CGI-I ratings were completed by an independent trained researcher blind to intervention group using anonymised baseline demographic information and ADIS-5 diagnoses with CSR ratings; together with baseline and 3 month follow-up data for the following measures: Target Situation vignettes and mean change scores; item-level data from the ASA-A and HADS; full scale and subscale scores from the ASA-A, HADS, WHOQoL-BREF plus disabilities module and ASQoL and EQ-5D-5L. Qualitative information about any change to anxiety-related situation(s) not already covered in the target situation vignettes.
Prior to the onset of the COVID-19 pandemic, all measures/interviews were completed face-to-face with the trained CRA at a location previously agreed with the participant (usually their home or a local NHS clinic). From March 2020, interviews were completed by telephone, video call, or text-based chat (according to participant preference). Questionnaires were completed online via Qualtrics (Qualtrics, 2005) because sending/returning paper questionnaires by post did not meet UK Government COVID-19 restrictions definition of ‘essential travel’.
Immersive Virtual Reality Environment-Delivered Graded Exposure Treatment (VRE) for Phobias, and Situational Anxiety
VRE uses visual images projected onto a screen (with sound) over four 20-min sessions. Participants interact with and navigate through graded exposure in relation to a specific phobia scenario using a tablet with trained therapist support (see Maskey et al., 2019a, 2019b, 2019c, 2019d) for a full description). Due to COVID-19 and treatment being delivered in 2020, it was not possible to use the VRE as planned, and thus CBT delivered by a therapist took place in real life settings, with use of appropriate Personal Protective Equipment and appropriate consideration of adjustments to graded exposure that were specific to the participants needs (e.g. sensory differences).
Current Clinical Services Plus (CCSP; Control Group)
Participants randomised to the control group were offered two standardised psycho-educational sessions based on the UaDE intervention module, focussing on understanding and describing emotions alongside information on basic coping strategies to help manage distress. They were then signposted (and referred if necessary) to NHS services available as part of usual care.
Change between baseline and follow up on target situation vignettes (3 months and 12 months post-intervention) and CGI-I (3 months post-intervention) was analysed descriptively. For both Target Situations and the CGI-I, frequencies of participants rated in each category of change (improved, no change, worsened) are reported by group. For questionnaires completed at baseline and follow up (immediate or 3 months post-intervention) change was analysed descriptively (means and standard deviations) at full-scale and, if appropriate, subscale level.
The Involvement of Autistic People and Relatives in this Research
All participants were recruited between November 2018 and October 2019 via NHS clinical services [community mental health services (including psychological therapies services) and adult autism assessment & diagnosis services]. Information regarding the rates of recruitment, retention and follow up can be found in Fig. 1.
Of the participants (N = 17) randomised to CCSP, one disengaged following dissatisfaction at the outcome of randomisation, withdrew consent for retention of baseline questionnaire data and did not provide follow-up data; 16 were offered two psychoeducational sessions. Twelve participants attended both sessions; 2 attended one session (home schooling a child and no reason given) and 2 attended neither session (problems getting to NHS premises and a family member in ill health). Support to attend sessions was offered but not accepted.
Transferrable skills. Many participants commented that the skills they learned in sessions were allowing them to manage anxiety in daily life.
I learnt some new techniques for managing anxiety and dealing with negative thoughts…They are useful techniques that work. I feel like I could draw on these skills on a daily basis” and “There was quite a lot of looking at specific things that bothered me, and using the same techniques to deal with them, and that really helped me to spot the patterns after the sessions stopped.
2.
Adjusted to meet autistic people’s needs. Several participants thought the intervention and therapists’ approach was set up to suit them (e.g., communication preferences).
[Therapist’s name redacted] would reword stuff in a different way for an autistic person so she would keep on asking questions, and asking them in a different way, and making sure I understood everything fully. Whereas before when I have had therapy people just expect you to understand stuff.
I have had therapy since I was 17, and this was by far the best therapy I have had…it has helped me so much in such a short space of time. I have grown so much and learnt so much about myself.” And “Everything is good now, my outlook on everything is different. I have made massive changes to my life…Everything is an option now.
I think it would have been helpful to having some continuity with [the therapist] or another service. For me it was a big change going from sessions to no sessions.
CCSP (Control Group)
One participant allocated to CCSP withdrew from the study due to randomisation outcome and another participant expressed they did not think there should be a control group. Several CCSP group participants expressed that the two psychoeducational sessions were of limited help and similar to support received in the past. However, many commented they felt glad to be a part of research and some reported that the two sessions were helpful. Several participants (across both arms) commented that they “felt part of something” and hoped that by taking part, they were supporting widening access to effective anxiety treatments for autistic people.
Outcome Measurement
Target Situation and Global Clinical Impression of Improvement (CGI-I)
Thirty-three participants chose two anxiety related situations, and one participant chose one situation. Participants identified a wide range of personally salient anxiety related contexts at baseline. The situations chosen most commonly related to: engagement with activities (e.g., hobbies, interests, employment/education, etc., N = 18 vignettes); attending to public places/events (e.g., supermarkets, restaurants, parks, shops, public transport, etc., N = 18); socialising with family or friends (N = 17); communicating with others (N = 8).
The return rates of questionnaire data were affected by the COVID-19 pandemic. Some participants suggested they would not be willing or able to complete the questionnaires over the telephone or on a screen. Descriptive data showing mean subscale and total scores on all outcome measures completed at baseline and immediately and three months post-intervention is shown in Supplementary Table 6. Data show that mean anxiety (measured by ASA-A and HADS-A) reduced from baseline to immediately post-intervention in both groups. There is score variability both within and between groups with wide standard deviation. There was no substantial change in QoL between baseline and 3-month follow-up in either group.
The complexities of the COVID-19 pandemic provided additional unexpected challenges to the delivery of both interventions, the research procedures and interpretation of the findings. The UK Government regulations, for example, restricted our ability to offer a VRE intervention as planned, and led to the use of non-face to face follow-up assessments including the use of telephone calls and on-line and other virtual methods for completion of outcome measures. In the wake of the pandemic it is likely that more flexible approaches to delivering interventions and assessment measures will need to continue and the advantages and disadvantages of different modes of delivery will require further evaluation.
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A Pilot Randomised Control Trial Exploring the Feasibility and Acceptability of Delivering a Personalised Modular Psychological Intervention for Anxiety Experienced by Autistic Adults: Personalised Anxiety Treatment-Autism (PAT-A)
Auteurs
Jacqui Rodgers Samuel Brice Patrick Welsh Barry Ingham Colin Wilson Gemma Evans Katie Steele Emily Cropper Ann Le Couteur Mark Freeston Jeremy R. Parr
