Internet-based Treatment for Adults With Autism Spectrum Disorder
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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%).

      Current study

      The current study originates from the above-mentioned ALMA treatment. The CBT based material
      used in ALMA has been transformed and adapted to an internet-based format. The effects of the
      internet-based version will be evaluated using the same population as in the ALMA study -
      i.e. adults with ASD.

      Purpose The purpose of the study is to investigate whether Internet-based CBT is feasible and
      effective in improving the quality of life and sense of coherence and decreasing symtoms of
      anxiety and depression among adults with ASD. Since internet based treatment is relatively
      unexplored for patients with ASD, we will also investigate the patients' subjective
      experience of such treatment, as well as systematically investigate what the written
      communication between patient and therapists will contain.

      Research questions

        1. Will adults with autism spectrum disorder follow an internet-based individual therapy
           that includes the possibility of participating in group sessions online for two
           semesters and, if so, will they experience it as meaningful?

        2. Will an internet-based treatment lead to a greater increase in quality of life compared
           to an active control group, and will this difference remain at follow-up after 6 and 12
           months?

        3. Will an internet-based treatment lead to decreased symptoms of depression and anxiety
           compared to an active control group and will this differences remain at follow up?

        4. How do participants experience internet-based treatment?

        5. What content does the written communication between therapists and participants have?

      Method

      Design and selection Randomized controlled treatment design with two conditions. The
      experiment group receives internet-based individual treatment with the possibility of
      participating in group discussions online. An active control group reads two books about ASD,
      one describing ASD and the other are stories of individuals who themselves have ASD. 84
      persons with ASD between 16 and 55 years will be recruited from all over the country.
      Exclusion criteria are ongoing psychotherapy with CBT or social behavior training, serious
      mental illness, mental developmental disorder or high risk of suicide. Additional exclusion
      criteria include inability to fill out forms and answer questions on the internet and
      inability to read and understand the Swedish language. Participants will either be randomized
      into the intervention group or active control group.

      Recruitment Information about the project is given to personnel working with the patient
      group in psychiatric and habilitation centers. Information will also be available in waiting
      rooms of healthcare facilities, in social media and on websites for psychiatric and
      autism-related associations, as well as through local press advertising. Potential
      participants will themselves submit an application of interest to participate via 1177.se,
      the website for Swedish healthcare e-services. Assessment interviews will be conducted
      through video link and symptoms of depression and other forms of psychopathology will be
      assessed through MINI-7 interviews.

      Intervention

      The intervention group receives 18 modules of internet based CBT (ICBT). The modules and
      excersices following every module will be provided in text. Each participant has a personal
      therapist who guides the participant throughout the treatment and provides support and
      feedback in connection to each completed module of the treatment. The modules contain the
      following themes:

        -  Psychoeducation - diagnostic criteria, symptoms, mentalization, perception etc

        -  Social interaction - relations, communication

        -  Mental health/illness - depression, anxiety

        -  Goal settings- individual goals, what can i change?

        -  Behavioral change - problem solving strategies, functional analyses

        -  Life style - food, sleep, physical activity

        -  Stress management - relaxation exercises and energy balancing.

        -  Everyday strategies - facilitate everyday life, structure and organization

        -  Social and civil rights - housing support, job opportunities.

      The sessions with group discussions will be held at a certain time every 2nd week. The
      discussions revolve around specific questions linked to the theme of the current treatment
      week. The discussions will be supervised and led by a therapist and are held through a closed
      discussion forum online.

      Control group The control group is offered self-studies by reading the book "What does the
      disability mean ?: Living with autism / Asperger syndrome", as well as a book containing
      biographical stories from people who themselves have ASD. The first book will be read during
      the first half of the project, and the second will be in the second half.

      Power Calculation The experience of treatment for adults with ASD is very limited, and
      therefore, there are quite few previous results to be based on when making assumptions about
      the expected effect. However, a previous study of adult patients with ASD found an effect
      size of d = 0.43 (SD = 1.68) on self-assessed quality of life, measured before and after CBT
      in group. To get 80% power to find a difference of that size (given an alpha level of 0.05),
      42 participants will be recruited. In the previous study (on site) there was a loss of 17%.
      It is difficult to estimate how much the loss occurs when the treatment is administered
      through internet, but if assumed that the loss is 50%, the intention is to include at least
      84 participants in order to answer the scientific questions. The calculations are made using
      the PS - Power and Sample Size Calculations software.

      Data Collection Each potential participant will initially be asked to answer a questionnaire
      online. The questionnaire includes questions about psychiatric symptoms, quality of life,
      demographic variables, employment and knowledge about ASD etc. Information that verifies the
      ASD diagnosis is obtained from the patients' medical record with the participant's consent.
      An interview via telephone is conducted with all potential participants and they are
      interviewed with a structured assessment tool for psychiatric diagnostics (M.I.N.I. version
      7). Data on patient satisfaction with treatment and possible side effects are obtained after
      the end of treatment.

      Measurement Quality of life is measured by Brunnsviken Brief quality of Life questionnaire
      (BBQ) and RAND-36 before and after the end of treatment and in a 6-month and one-year
      follow-up. EQ-5D and Sense of Coherence Scale (SOC) measure overall health and experience of
      context. Depression and anxiety are measured with Hospital Anxiety Depression Scale (HADS),
      schizotypic traits with SPQ and obsessive symptoms are assessed with BOCS. Suicide thoughts
      are examined using one item in PHQ-9 in addition to structured questions about suicidal
      thoughts included in the structured diagnostic interview material M.I.N.I. (version 7.0.0).
      The self-assessment form RAADS - Ritvo Autism-Asperger's Diagnostic Scale is used to measure
      autistic traits. Knowledge about autism is measured before, during and after treatment using
      Autism Knowledge questionnaire, which is a questionnaire created for the project.
      Self-acceptance, self-awareness, mood and ability to ask for help, as well as the extent of
      social contacts, sickness absence, and occurrence of work / studies will be measured before
      and after the intervention using a battery of questions compiled for the project.
      Satisfaction with the treatment is measured with CSQ and negative side effects are measured
      through Negative Effects questionnaire (NEQ) after the end of treatment.
    

Intervention name(s): Internet-based treatment for adults with autism spectrum; Psychoeducation about autism spectum disorder
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Internet-based CBT. The intervention includes 18 modules focusing on: Psychoeducation, individual goal setting, behavioral change, management strategies and stress management; Self-studies by reading the book "What does the disability mean ?: Living with autism / Asperger syndrome. Project Empowerment "(2004), by Norrö & Swing Åström, as well as a book of biographical stories of people who have ASD. The first book will be read during the first half of the project, and the second will be in the second half.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Life quality; ASD; Internet based treatment; Autism; ICBT