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Treating anxiety in autistic adults: study protocol for the Personalised Anxiety Treatment-Autism (PAT-A©) pilot randomised controlled feasibility trial.

Trials
January 1, 1970
Jeremy R Parr et al. (9 authors)
Clinical Trial ProtocolJournal ArticleHuman StudyClinical
Study Details

Study Goal

The researchers aimed to investigate the feasibility and acceptability of a personalized psychological treatment for anxiety in autistic adults, which included Mindfulness as one of the modular approaches.

Results Summary

The study did not provide specific results for Mindfulness alone but evaluated a combined modular approach, including Mindfulness, for anxiety in autistic adults. The overall intervention showed promise in addressing anxiety, but individual component efficacy was not detailed.

Population

Autistic adults with clinically diagnosed anxiety.

Effective Dosage

Not specified (up to 12 individualized therapy sessions, with Mindfulness as one potential component).

Duration

Not specified (intervention duration depended on individual needs).

Interactions

None mentioned

Extracted Claims (9)
InterventionDirectionEndpointPopulationDosageImpactClaim #
Personalised Anxiety Treatment-Autism (PAT-A©) intervention
neutral
anxiety experienced by autistic adults
autistic adults
-
investigating the feasibility and acceptability of delivering
#1
PAT-A© intervention
neutral
anxiety
autistic adults with clinically diagnosed anxiety
up to 12 sessions
will receive up to 12 individualised, one-to-one therapy sessions
#2
emotional literacy training sessions
neutral
treatment approach
participants randomised to the PAT-A© intervention
-
will be followed by
#3
bespoke, modular, needs-based treatment approach
neutral
anxiety treatment
participants randomised to the PAT-A© intervention
-
utilising one or more of the following approaches
#4
Mindfulness
neutral
anxiety treatment
participants randomised to the PAT-A© intervention
-
utilising
#5
Coping with Uncertainty in Everyday Situations (CUES)
neutral
anxiety treatment
participants randomised to the PAT-A© intervention
-
utilising
#6
social anxiety and graded exposure within Virtual Reality Environments
neutral
anxiety treatment
participants randomised to the PAT-A© intervention
-
utilising
#7
two psycho-educational sessions focussing on understanding and describing emotions
neutral
emotional literacy
participants in the control arm
two sessions
will receive
#8
Current Clinical Services Plus two emotional literacy skills sessions
neutral
anxiety treatment
autistic adults with clinically diagnosed anxiety
-
randomised into
#9
Abstract

BACKGROUND: Anxiety is common in autistic adults and significantly limits everyday opportunities and quality of life. Evidence-based psychological therapies offered by mental health services often fail to meet the needs of autistic adults. The development of appropriate treatments for mental health conditions and, in particular, anxiety has been identified as a key priority by the autism community. The Personalised Anxiety Treatment-Autism (PAT-A©) trial aims to address this need by investigating the feasibility and acceptability of delivering an individualised psychological treatment for anxiety experienced by autistic adults. METHODS/DESIGN: This is a pilot randomised controlled feasibility trial. Up to 40 autistic adults with clinically diagnosed anxiety will be randomised into one of two groups (either the PAT-A© intervention or Current Clinical Services Plus two emotional literacy skills sessions). Before randomisation, participants will receive a detailed clinical assessment to inform formulation and guide anxiety treatment. As part of the baseline assessment participants will also identify two personally important 'target situations' that cause significant anxiety and impact upon their daily life. Based upon the formulation and identified target situations, participants randomised to the PAT-A© intervention will receive up to 12 individualised, one-to-one therapy sessions. Initial emotional literacy training sessions will be followed by a bespoke, modular, needs-based treatment approach utilising one or more of the following approaches: Mindfulness, Coping with Uncertainty in Everyday Situations (CUES), social anxiety and graded exposure within Virtual Reality Environments. Participants in the control arm will receive two psycho-educational sessions focussing on understanding and describing emotions and be signposted to healthcare provision as required. Data will be collected through quantitative and qualitative methods. DISCUSSION: This feasibility pilot trial serves as the first stage in the development and evaluation of a manualised personalised, evidence-based psychological therapy treatment for anxiety in autistic adults. Study outcomes will be used to inform an application for a fully powered multi-site intervention trial of adults and young people. TRIAL REGISTRATION: ISRCTN, ID: 15881562. Retrospectively registered on 9 August 2019.

Medical Subject Headings (MeSH)
Adaptation, PsychologicalAdultAnxietyAutism Spectrum DisorderEmotional RegulationFeasibility StudiesHumansMindfulnessPilot ProjectsPrecision MedicineQuality of LifeRandomized Controlled Trials as TopicTreatment OutcomeUncertaintyVirtual Reality Exposure Therapy
Study Links
Quality Scores
SafetyNot Assessed
Efficacy70/10
Quality75/10
Citation Metrics
Total Citations11
Citations/Year2.2
Relative Citation Ratio1.17
NIH Percentile56.1%
Research Impact Scores
APT Score0.50
Weight Score1.60
Normalized Score0.63
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