Guided ACT and for Adults With ASD

Autism Spectrum Disorder (ASD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04376151
• Other study ID #: 245597
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: August 20, 2022

Study information

• Verified date: May 2021
• Source: University of Lincoln
• Contact: Megan J Mellor
• Phone: 07870449692
• Email: 16662521[@]students.lincoln.ac.uk
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8
• Est. completion date: August 20, 2022
• Est. primary completion date: January 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 18+ years old with a formal diagnosis of Autistic Spectrum Disorder, without a diagnosis if an Intellectual Disability.

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:

1. Unable to communicate fluently in English (justification: the cost of hiring an interpreter).

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).

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autism Spectrum Disorder (ASD)

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United Kingdom	Nottingham City Autisum Service	Nottingham	Nottinghamshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Lincoln	Nottinghamshire Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (10)

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. — View Citation

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

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. Epub 2007 Nov 23. — View Citation

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. — View Citation

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. — View Citation

Jacobson NS, Follette WC, & Revenstorf D. Psychotherapy outcome research: Methods for reporting variability and evaluating clinical significance. Behavior therapy 15(4):336-352, 1984.

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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