An interventional study of Internet-based treatment for adults with autism spectrum and Psychoeducation about autism spectum disorder in Autism Spectrum Disorder, sponsored by Örebro County Council. Completed at 1 site in Sweden. Open to participants aged 16 Years to 55 Years. Per ClinicalTrials.gov, last updated 2025-04-04.
Sponsored by Örebro County Council · Not applicable, Interventional, and Treatment
Among 18 studies in Autistic Disorder with a site in Sweden — 6 open to participants now, 8 under way, none of them phase 3. Autistic Disorder · Sweden.
Among the 18 studies in Autistic Disorder with a site in Sweden, this one is the 5th largest by enrollment of the 14 interventional ones that give a count, is one of 3 that started in 2018, is one of 14 with no phase, and was the 4th registered.
1,033 studies on the registry are indexed under Autistic Disorder; 269 are open to participants now.
Browse Autistic Disorder studies →6 of the 18 studies in Autistic Disorder with a site in Sweden are open now. Recruiting first, the newest first:
Värmland County Council, Sweden · Sites in Sweden
Ages 20–35
Umeå University · Sites in Sweden
Ages 18+ · Healthy volunteers
Region Skane · Sites in Sweden
Ages 8+
Linkoeping University · Sites in Sweden
Ages 2–10
Region Örebro County · Sites in Sweden
Ages 18+
A study can be open while its sites in Sweden have not opened yet or have stopped. Only those recruiting at a site in Sweden →
Of the 183 Autistic Disorder studies recruiting now, 33 (18%) set no upper age limit and 143 (78%) stop at 75 or younger; 148 take children under 18; 56 take healthy volunteers.
This study: 16 Years to 55 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
18 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 3 started in 2018.
This study's enrollment of 84 is above the median of 49 across 813 interventional studies indexed under Autistic Disorder.
Median enrollment 66 across the 14 interventional studies, 102 across the 4 observational. Of the 10 that completed or were terminated, 0 (0%) have results posted.
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None of the 18 has an industry lead sponsor. The 10 most frequent:
Örebro County Council is the lead sponsor of 22 studies on the registry; none are open to participants now.
Örebro County Council has 1 study filed under Autistic Disorder — fewer than ten, so there is no comparison to draw.
2 of the studies in Autistic Disorder with a site in Sweden that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05867940Region SkaneEffects of Physical Activity on Prescription (PAP) as a Health-enhancing Intervention in People With Disabilities | 2026-12 |
| NCT07427810Värmland County Council, SwedenFollow-up of Adolescents With Autism and Psychotic Symptoms - Psychiatric Co-morbidity and Functional Impairment. | 2027-06 |
Add all 2 to your calendar (.ics) → With an account.
Among the 18 studies in Autistic Disorder with a site in Sweden, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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
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:
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.
1,033 studies on the registry are indexed under Autistic Disorder; 269 are open to participants now.
This study's enrollment of 84 is above the median of 49 across 813 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →Örebro County Council is the lead sponsor of 22 studies on the registry; none are open to participants now.
Compared within Autistic Disorder, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Autism Spectrum Disorder. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
18 week internet-based CBT with therapist support. Regular online group discussions.
Behavioral: Internet-based treatment for adults with autism spectrum
Reads 2 books about Autism Spectrum Disorder (ASD)
Behavioral: Psychoeducation about autism spectum disorder
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.
Change in life quality
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
Time frame: Change from Baseline, at 9 weeks, at 18 weeks, at 6 months and at 12 months
Change in Sense of coherence
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.
Time frame: Change from Baseline, at 18 weeks, at 6 months and at 12 months
Change in depressive and anxiety symptoms
Possible interaction effect between group and time in respect of differences in Depressive and anxiety symptoms of the intervention group and the control group between pre, post and follow-up measurement. Depression and anxiety symptoms will be measured using HADS
Time frame: Change from Baseline, at 9 weeks, at 18 weeks, at 6 months and at 12 months
Subjective experience of ICBT
The subjective experience of participating in an internet based treatment will be qualitatively evaluated using semi structured interview.
Time frame: At 19 weeks
Content of communication
Thematic content of the written communication between participant and therapist will be assessed using content analysis.
Time frame: At 20 weeks
Ran from Aug 2018 to primary completion in May 2020, 21 months.
Of 355 non-industry interventional studies with no phase under Autistic Disorder, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 52. This study's 21 months is below that.
Counting every sponsor, half of 367 studies reached it within 26 months; a quarter within 13 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Örebro County Council