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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04376151
Study type Interventional
Source University of Lincoln
Contact Megan J Mellor
Phone 07870449692
Email 16662521@students.lincoln.ac.uk
Status Recruiting
Phase N/A
Start date September 1, 2020
Completion date August 20, 2022

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