Guided ACT and for Adults With ASD

NCT04376151 | Unknown

• 1 other identifier: 245597
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autism Spectrum Disorder (ASD)

Outcome Measures

Primary Outcomes (3)

• 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: 1. 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 2. Behavioural Activation (BA) subscale (out of 30): Higher scores indicate greater behavioural awareness (mindful attention to current actions) 3. 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. 1. 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). 2. Behavioural Awareness (BA) subscale (0-12) higher scores indicating greater behavioural awareness (mindful attention to current actions). 3. 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 Outcomes (2)

• Personal Questionnaire (PQ) repeated measure of change

  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

  Administered pre-intervention, weekly during baseline and intervention phase, two and four week post intervention

Study Arms (1)

Intervention

EXPERIMENTAL

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'

Interventions

Acceptance and Commiment Therapy (ACT) bibliotherapy 'Get Out of Your Mind and Into Your Life' OTHER

The intervention has been described in the arm/group descriptions.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Lincoln: lead
• Nottinghamshire Healthcare NHS Trust: collaborator

Study Sites (1)

Nottingham City Autisum Service

Nottingham, Nottinghamshire, NG6 9DR, United Kingdom

RECRUITING

Related 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.

  PMID: 25547522 BACKGROUND

• 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.

  PMID: 16300724 BACKGROUND

• 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.

  PMID: 25073750 BACKGROUND

• 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.

  PMID: 23883189 BACKGROUND

• 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.

  PMID: 16897387 BACKGROUND

• 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.

  PMID: 23999201 BACKGROUND

• 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.

  PMID: 27592496 BACKGROUND

• 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

  BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 18033980 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• David Dawson

  The University of Lincoln

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan J Mellor

CONTACT

07870449692; 16662521@students.lincoln.ac.uk

Sam Lewis

CONTACT

01522 835490; sponcer@lincoln.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: May 6, 2020
• Study Start: September 1, 2020
• Primary Completion: January 20, 2022
• Study Completion: August 20, 2022
• Last Updated: May 5, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)