Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
8 participants
INTERVENTIONAL
2020-09-01
2022-08-20
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Intervention
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.
Acceptance and Commiment Therapy (ACT) bibliotherapy 'Get Out of Your Mind and Into Your Life'
The intervention has been described in the arm/group descriptions.
Interventions
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Acceptance and Commiment Therapy (ACT) bibliotherapy 'Get Out of Your Mind and Into Your Life'
The intervention has been described in the arm/group descriptions.
Eligibility Criteria
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Inclusion Criteria
2. To be over the age of 18 years.
3. Accessing Nottingham City Autism Service
4. Experiencing elevated anxiety, and / or stress, and /or depression and meet the clinical threshold or moderate on the Depression, Anxiety and Stress Scale.
5. Access to the internet via an electronic device (to complete electronic measures).
6. 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
2. Unable to read English (justification: participant will be unable to read and engage in the bibliotherapy)
3. 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).
4. If they have a co-morbid diagnosis of intellectual disability (justification: may have different needs regarding therapy adaptations.
5. No access to mobile or internet (justification: unable to complete measures).
18 Years
ALL
Yes
Sponsors
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Nottinghamshire Healthcare NHS Trust
OTHER_GOV
University of Lincoln
OTHER
Responsible Party
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Principal Investigators
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David Dawson
Role: PRINCIPAL_INVESTIGATOR
The University of Lincoln
Locations
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Nottingham City Autisum Service
Nottingham, Nottinghamshire, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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A-Tjak JG, Davis ML, Morina N, Powers MB, Smits JA, Emmelkamp PM. A meta-analysis of the efficacy of acceptance and commitment therapy for clinically relevant mental and physical health problems. Psychother Psychosom. 2015;84(1):30-6. doi: 10.1159/000365764. Epub 2014 Dec 24.
Hayes SC, Luoma JB, Bond FW, Masuda A, Lillis J. Acceptance and commitment therapy: model, processes and outcomes. Behav Res Ther. 2006 Jan;44(1):1-25. doi: 10.1016/j.brat.2005.06.006.
Hirvikoski T, Blomqvist M. High self-perceived stress and poor coping in intellectually able adults with autism spectrum disorder. Autism. 2015 Aug;19(6):752-7. doi: 10.1177/1362361314543530. Epub 2014 Jul 29.
Lane JD, Gast DL. Visual analysis in single case experimental design studies: brief review and guidelines. Neuropsychol Rehabil. 2014;24(3-4):445-63. doi: 10.1080/09602011.2013.815636. Epub 2013 Jul 24.
Lecavalier L. Behavioral and emotional problems in young people with pervasive developmental disorders: relative prevalence, effects of subject characteristics, and empirical classification. J Autism Dev Disord. 2006 Nov;36(8):1101-14. doi: 10.1007/s10803-006-0147-5.
Swain J, Hancock K, Hainsworth C, Bowman J. Acceptance and commitment therapy in the treatment of anxiety: a systematic review. Clin Psychol Rev. 2013 Dec;33(8):965-78. doi: 10.1016/j.cpr.2013.07.002. Epub 2013 Jul 16.
Weston L, Hodgekins J, Langdon PE. Effectiveness of cognitive behavioural therapy with people who have autistic spectrum disorders: A systematic review and meta-analysis. Clin Psychol Rev. 2016 Nov;49:41-54. doi: 10.1016/j.cpr.2016.08.001. Epub 2016 Aug 4.
Bruggink A., Huisman S., Vuijk R, Kraaij V, & Garnefski N. Cognitive emotion regulation, anxiety and depression in adults with autism spectrum disorder. Research in Autism Spectrum Disorders 22, 34-44, 2016
Jacobson NS, Follette WC, & Revenstorf D. Psychotherapy outcome research: Methods for reporting variability and evaluating clinical significance. Behavior therapy 15(4):336-352, 1984.
Cath DC, Ran N, Smit JH, van Balkom AJ, Comijs HC. Symptom overlap between autism spectrum disorder, generalized social anxiety disorder and obsessive-compulsive disorder in adults: a preliminary case-controlled study. Psychopathology. 2008;41(2):101-10. doi: 10.1159/000111555. Epub 2007 Nov 23.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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245597
Identifier Type: -
Identifier Source: org_study_id
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