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临床试验/NCT04376151
NCT04376151Unknown不适用

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

University of Lincoln2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
8
试验地点
2
主要终点
Comprehensive Assessment of Acceptance and Commitment Therapy Process (CompACT) repeated measure of change

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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).

结局指标

主要结局

Comprehensive Assessment of Acceptance and Commitment Therapy Process (CompACT) repeated measure of change

时间窗: Administered pre-intervention phase, two week and four week post intervention

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).

The Depression, Anxiety and Stress Scale (DASS-21) repeated measure of change

时间窗: Administered as a screening questionaire; weekly during baseline and intervention phase, two and four weeks post intervention phase.

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+

Comprehensive Assessment of Acceptance and Commitment Therapy Process (CompACT short form) repeated measure of change

时间窗: Administered every three days during baseline and intervention period

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).

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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