Guided ACT and for Adults With ASD

Study Overview
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Brief Summary
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This study aims to investigate the efficacy of guided self-help Acceptance Commitment Therapy (ACT) for adults who have a diagnosis for Autistic Spectrum Disorder (ASD) and are experiencing psychological distress (stress, anxiety or depression). This is a repeated measures design, using a single case experimental design (SCED) over a period of fourteen weeks. Each participant (n=8) with be asked to complete weekly measures and shortened measures every three days, while they read an ACT guided self-help bibliotherapy. For more information about the measures, please see outcome measure section. The ACT guided bibliotherapy will be administered to each participant on a weekly basis, over eight weeks. Participants will be asked to complete outcome measures at two week and at four weeks post intervention.

Detailed Description
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INTRODUCTION High levels of psychiatric co-morbidity have been found with adults who receive a diagnosis of Autistic Spectrum Disorder (ASD); including stress, anxiety, depression and OCD. Acceptance and Commitment Therapy (ACT) is a psychotherapeutic approach and is referred to as a third wave CBT. There have been over one hundred randomized control trials (RCTs) supporting the efficacy of ACT for different types of distress and severity. Researchers conducted an ACT based group, for students with ASD; the results indicated that levels of stress, hyperactivity and emotional distress were reduced in the treatment group, compared to classes as unusual. Results were maintained or improved at a two month follow up. However, little is still known about the efficacy of ACT for adults with ASD who experience. This research will indicate if guided ACT self-help facilitates increases psychological flexibility for adults with ASD, which is known to be less developed in people with ASD. Psychological flexibility mediates the experience of psychological distress, for example depression, anxiety and stress, which are known to be highly prevalent in this population. Currently, there are mixed results in relation to effectiveness of CBT; very few researchers have measured the effectiveness of ACT to increase psychological flexibility in an adult ASD population and determine if this mediates a reduction in psychological distress. PURPOSE OF THE STUDY This research will add to the knowledge about how ACT guided self-help can be adapted for adults with ASD. It will give results on how effective ACT guided self-help is in supporting adults with ASD, to increase psychological flexibility and reduce psychological distress. If guided ACT self-help intervention is effective; this will help increase access and availability of psychological intervention for people with ASD, specifically in relation to associated difficulties in social communication and interaction. PRIMARY OBJECTIVE To examine whether an ACT bibliotherapy intervention, for adults with a diagnosis of ASD who experience psychological distress, increases psychological flexibility. SECONDARY OBJECTIVE(S) To examine whether psychological flexibility mediates changes in; personally-identified therapeutic goals, increasing psychological wellbeing and decreasing anxiety, stress and depression. STUDY DESIGN This is a repeated measures design, using a single case experimental design (SCED). Each participant with be asked to complete weekly measures and shortened measure every three days, please see the outcome measures section for more details of the measures and timeframes. Weekly data collection will last for approximately 10 weeks (baseline and intervention phase), with a two week and four week follow-up. DATA ANALYSIS SCED data will be predominantly analysed using visual analysis. Data will be plotted onto graphs to analyse the direction of the data (trend), the magnitude (level) and the variability of the data (stability). To find out if change from pre and post scores is reliable, a Reliable Change Index (RCI) will be conducted. To determine if any change is clinically significant, a Clinically Significant Criterion (CSC) will be conducted. The data will be analysed at the University of Lincoln and Students home (via secured sites). The data will be analysed using Excel software. No interim analysis is planned for safety, efficacy or management purposes.

Official Title
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Acceptance and Commitment Therapy Guided Self-help for Adults With a Diagnosis of Autistic Spectrum Disorder Experiencing Psychological Distress

Conditions
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Autism Spectrum Disorder (ASD)

Intervention / Treatment
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* Other: Acceptance and Commiment Therapy (ACT) bibliotherapy 'Get Out of Your Mind and Into Your Life'


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18+ years old with a formal diagnosis of Autistic Spectrum Disorder, without a diagnosis if an Intellectual Disability. To be over the age of 18 years. Accessing Nottingham City Autism Service Experiencing elevated anxiety, and / or stress, and /or depression and meet the clinical threshold or moderate on the Depression, Anxiety and Stress Scale. Access to the internet via an electronic device (to complete electronic measures). Agreement and knowledge of the time commitment for the completion of the intervention, competition of measure and change questionnaire at the end of the study. Exclusion Criteria: Unable to communicate fluently in English (justification: the cost of hiring an interpreter). Unable to read English (justification: participant will be unable to read and engage in the bibliotherapy) Adults who are currently accessing psychological therapy. If participants start psychological therapy during the study, they will be removed from the study (justification: unable to separate out effects of research intervention from psychological therapy intervention). If they have a co-morbid diagnosis of intellectual disability (justification: may have different needs regarding therapy adaptations. No access to mobile or internet (justification: unable to complete measures).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: The intervention is a guided self-help Acceptance and Commitment Therapy (ACT) bibliotherapy, written by Steven Hayes called 'Get Out of your Mind and Into Your Life'. This book has been split into eight sections, participants will be asked to read one section each week. Each week each participant will speak with the researcher to ask any questions and review the weeks material via a guided telephone call. All telephone calls will follow a pre-determined list of questions to increase standardisation and recorded for fidelity checks.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Participants will work through an Acceptance and Commitment Therapy informed self-help bibliotherapy over a period of eight weeks. The bibliotherapy is called 'Get Out of Your Life and Into your Mind' written by Steve. C. Hayes. | Other: Acceptance and Commiment Therapy (ACT) bibliotherapy 'Get Out of Your Mind and Into Your Life'<br>* The intervention has been described in the arm/group descriptions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comprehensive Assessment of Acceptance and Commitment Therapy Process (CompACT) repeated measure of change | 23 Item measure of Psychological Flexibility The CompACT total score (out of 138). Higher scores indicate greater psychological flexibility (openness, awareness and activation) Th CompACT can also be separated into three subscales: Openness to Experince (OE) subscale (out of 60): Higher scores indicate greater openness to experience - i.e., willingness to experience internal events (thoughts, feelings, sensations, etc.) without trying to control or avoid them Behavioural Activation (BA) subscale (out of 30): Higher scores indicate greater behavioural awareness (mindful attention to current actions) Valued Action (VA) subscale (out of 48): Higher scores indicate greater engagement in valued actions (meaningful activity). | Administered pre-intervention phase, two week and four week post intervention | 
| Comprehensive Assessment of Acceptance and Commitment Therapy Process (CompACT short form) repeated measure of change | 8 Item measure of Psychological Flexibility. Scores are derived by summing responses for each of the three subscales (Openness to Experience; Behavioural Awareness; Valued Action) or the scale as a whole (CompACT Total score). The full-scale CompACT Total score ranges from 0-48, with higher scores indicating greater psychological flexibility: The ability to attend and adapt to situational demands in the pursuit of personally meaningful longer-term goals. Openness to Experience (OE) subscale (0-18) higher scores indicating greater openness to experience (willingness to experience internal events [thoughts, feelings, sensations, etc.] without trying to control or avoid them). Behavioural Awareness (BA) subscale (0-12) higher scores indicating greater behavioural awareness (mindful attention to current actions). Valued Action (VA) subscale (0-18) with higher scores indicating greater engagement in valued actions (meaningful activity). | Administered every three days during baseline and intervention period | 
| The Depression, Anxiety and Stress Scale (DASS-21) repeated measure of change | 21 Item measure of depression, stress and anxiety Scores for Depression, Anxiety and Stress are calculated by summing the scores for the relevant items. Recommended cut-off scores for conventional severity labels (normal, moderate, severe) are as follows: Depression: Normal 0-9, Mild 0-13, Moderate 14-20, Severe 21-27, Extremely Severe 28+ Anxiety: Normal 0-7, Mild 8-9, Moderate -14, Severe 15-19, Extremely Severe 20+ Stress: Normal 0-14, Mild 15-18, Moderate 19-25,Severe 26-33, Extremely Severe 37+ | Administered as a screening questionaire; weekly during baseline and intervention phase, two and four weeks post intervention phase. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Personal Questionnaire (PQ) repeated measure of change | 3 Item statements created by the client and based upon the clients values The Personal Questionnaire (PQ) is an expanded target complaint measure which is individualized for each client. It intended to be a list of problems or behaviours that the client wishes to work on during the intervention, stated in the client's own words. Clients rate each question on a likert scale scale (0-5), higher scores indicating more success/achievement at the target behaviour. | Administered once during pre-intervention phase, Two and four weeks post intervention phase | 
| World Health Organisation Quality of Life Questionnaire (WHO-QoL- BRIEF) repeated measure of change | 26 Item measure assessing Quality of Life. The WHOQOL-BREF produces a quality of life profile. It is possible to derive four domain scores; physical health (out of 35), psychological (out of 30), social relationships (out of 15) and environment (out of 40). There are also two items that are examined separately: question 1 asks about an individuals overall perception of quality of life and question 2 asks about an individuals overall perception of their health. The four domain scores denote an individuals perception of quality of life in each particular domain. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). | Administered pre-intervention, weekly during baseline and intervention phase, two and four week post intervention |