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临床试验/NCT03570372
NCT03570372已完成不适用

Internet-based Treatment for Adults With Autism Spectrum Disorder (MILAS)

Örebro County Council2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2018年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
84
试验地点
2
主要终点
Change in life quality

研究概览

简要总结

The group of patients diagnosed with Autism spectrum disorder (ASD) is increasing and so is the need for new and effective treatment methods. ASD is characterized, among other things, by difficulties in social interaction and communication. These difficulties often affects their quality of life and causes a risk of developing social anxiety or other forms of mental illness, which often leads to isolation and may cause difficulties in participating in regular face- to- face psychological treatment. Although research shows that group therapy is favorable for this group of patients, many with ASD refrain from group-treatment due to social anxiety or difficulties with public transport. In order to increase the availability of evidence based psychological treatment for these patients, it seems important to be able to offer a web-based treatment option, with the ability to participate in online group sessions.

The aim of the study is to investigate whether Internet-based CBT is an effective method of improving the quality of life and sense of coherence and decreasing symtoms of anxiety and depression among adults with ASD.

A randomized controlled study design will be used. Assessment will be conducted through video interviews, recruiting 84 patients with ASD and normal intellectual abilities. Symptoms of depression and other forms of psychopathology will be assessed through MINI-7 interviews. Primary outcome measures are quality of life. Participants in the intervention group receives a 18 week blended treatment combining individual ICBT delivered through a treatment platform called Stöd och Behandling (SOB) with the opportunity to participate in regular group discussions delivered through a discussion forum online. Participants in the control groups are offered self-studies through psycho educative books about ASD. Data will be collected at baseline, mid-treatment, post-treatment and after six and 12 months.

详细描述

Background Autism Spectrum Disorder (ASD) is characterized by significant difficulties in social interaction and communication as well as routine boundaries and constraints in behavioral patterns. People with ASD have difficulties in the ability to mentalize, i.e. difficulties in understanding how another person feels and thinks. Another characteristic of persons with ASD is that they are detailed in their way of processing information and therefore have difficulties in generalizing and managing changes in everyday life. Lacking in planning, organizing, evaluating and adjusting their behaviors can lead to extensive needs of support. About 40% of adult patients with ASD exhibit depressive symptoms, and different types of anxiety disorders are also very common. Many people experience constant stress and vigilance following efforts to behave socially adequately and managing unpredictable situations. The difficultiess is often combined with chronic stress and experience of failures and misunderstandings. In addition to having difficulties in socializing, many also have difficulties in initiating and solving problems, which contributes to unemployment.

Psychological treatment Many people with ASD find it difficult to identify and express feelings and thoughts, which is a common element in psychotherapeutic treatment. This can hinder psychological treatment from progressing as expected. The goals of treatment are often to increase the person's quality of life and ability to live an independent life, and a major focus in treatment for children with ASD is on psycho education, cognitive interventions and social skills. Treatment of adults with ASD is less explored. Experience from clinical practice suggests that psychological interventions should be practical and focused on behavioral change strategies, but to date, few treatments using Cognitive Behavioral Therapy (CBT) have been scientifically evaluated for persons with ASD.

A group format has been considered to have several benefits in psychological treatment for adults with ASD. It offers an opportunity for participants to discover that they are not alone in their quest to fit in socially. A group also provides the opportunity to reproduce problematic social situations, provide behavioral feedback and enable exercises of skills in a structured environment.

In several studies, internet based psychological treatment has proven to be effective in treating a variety of psychiatric diagnoses. Courses and information-based training materials have been offered in some regions in Sweden, but only for children and adolescents with ASD. Until now, no internet based cognitive behavioral treatment (ICBT) has been used for treating adults with ASD. Since many with ASD have severe social anxiety or having difficulty with travel, it seems important to be able to offer a web-based treatment option. This could enable social interaction, learning and a sense of belonging, regardless of where they live and the ability to leave the home as well as contributing to a more equal care.

Earlier study A swedish research group have developed a group based CBT manual (called ALMA) for adults with ASD. The treatment aims to give participants a deep understanding of the diagnosis and increase their quality of life. A randomized controlled study of this treatment has been published in a reputable journal . Groups of 6-8 adults with ASD received the intervention for a total of two semesters. The treatment significantly improved the quality of life (Cohen's d = 0.43) and in a cumulative long-term follow-up (> 8 months), it was found that the improvement was lasting. In addition, 88% of the participants gained increased self-understanding, higher self-acceptance (72%) and increased well-being (67%).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
16 Years 至 55 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Must have ASD diagnosis
  • Must have normal IQ
  • Must be able to understand and read swedish

排除标准

  • high risk of suicide
  • psychosis
  • inability to fill out forms and answer questions on the internet
  • inability to read and understand the Swedish language
  • ongoing psychotherapy with CBT or social behavior training
  • mental development disorder

结局指标

主要结局

Change in life quality

时间窗: Change from Baseline, at 9 weeks, at 18 weeks, at 6 months and at 12 months

Possible interaction effect between group and time in respect of differences in quality of life of the intervention group and the control group between pre, post and follow-up measurement

Change in Sense of coherence

时间窗: Change from Baseline, at 18 weeks, at 6 months and at 12 months

Possible interaction effect between group and time in respect of differences in Sense of coherence of the intervention group and the control group between pre, post and follow-up measurement. Sense of coherence will be measured using SOC-13 questionnaire.

次要结局

  • Change in depressive and anxiety symptoms(Change from Baseline, at 9 weeks, at 18 weeks, at 6 months and at 12 months)
  • Subjective experience of ICBT(At 19 weeks)
  • Content of communication(At 20 weeks)

研究者

发起方
Örebro County Council
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Fredrik Holländare

Doctor of Philosophy

Region Örebro County

研究点 (2)

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