AutismTINANCT07840261
Tailored and Transdiagnostic Internetbased Intervention for Autistic Adults
A study testing Tailored And Transdiagnostic Internetbased intervention for Autistic adults in people with Autism, run by Region Örebro County at 1 site in Sweden.
Trial summary
The number of individuals receiving an autism diagnosis is increasing, particularly among individuals without co-occurring intellectual disability. This group does not always present with stereotypically autistic characteristics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autism
- What is being tested?
- Tailored And Transdiagnostic Internetbased intervention for Autistic adults
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSweden
- Study dates
- 1 Apr 2027to 30 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults (>18 years) with a diagnosis of autism without intellectual disability who experience some form of difficulty or psychological distress related to their autism diagnosis.
Who cannot join
- intellectual disability, severe anxiety, severe depression, psychosis, suicidal behavior, suicide risk, or ongoing psychological treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Vuxenhabiliteringen, Region Örebro Län
Örebro
Britta Westerberg, Med. dr, 0046767672800, britta.westerberg@regionorebrolan.se
About this study
The number of individuals receiving an autism diagnosis is increasing, particularly among individuals without co-occurring intellectual disability. This group does not always present with stereotypically autistic characteristics. Instead, the cognitive mechanisms underlying autistic functioning often manifest in less apparent difficulties, such as difficulties with self-acceptance, low self-esteem, stress-related problems, low energy, or anxiety. At the same time, this group is highly heterogeneous in terms of abilities and difficulties, and consequently, their needs also vary.
Over the past decades, it has become increasingly evident that autistic adults have substantial needs for support for psychological distress, while healthcare services have difficulties meeting these needs. This is likely due to a combination of limited resources and a lack of adapted and accessible interventions.
Read more
Providing psychological treatment via the internet may be one way of increasing access to healthcare for this population. Internet-based interventions have been shown to be effective in treating mental health problems in other patient populations, and the internet-based format may be well suited to the needs and preferences commonly reported by autistic individuals.
Within this project, we are developing an internet-based treatment for autistic adults aimed at increasing individuals' understanding of themselves and their difficulties, as well as improving self-esteem and self-acceptance. In the longer term, we hope that the treatment may also contribute to improved quality of life and sense of coherence, as well as reduced levels of anxiety and depression.
The treatment is intended for autistic adults experiencing some form of psychological distress. It consists of text-based modules, and participants complete exercises with the support of an individual therapist who guides them through the treatment. If the treatment proves to be effective, our hope is that it can be implemented within Swedish habilitation services as an alternative to face-to-face psychological treatment.
Read the detailed description
Aim and objectives
This study aims to investigate the effects of an individualized internet-based intervention for adults with autism who experience some form of distress that is wholly or partly related to their disability. The intervention aims to increase participants' understanding of themselves from a biopsychosocial perspective, provide them with strategies to manage difficulties associated with autism, and promote greater self-acceptance and self-compassion. In the longer term, the intervention is expected to contribute to improved quality of life and sense of coherence.
Research questions
In this initial pilot study, we aim to investigate the feasibility of the intervention. Specifically, we will examine whether the intervention can be delivered as intended, whether participants understand its content, whether the internet-based platform functions as intended, whether the selected outcome measures are appropriate, whether the observed variability in outcome measures is adequate, and whether participant attrition is acceptable. The findings from this pilot study may also inform a future power analysis for a randomized controlled trial (RCT).
Methods Design
The first planned study is a pilot study with a pre-post design aimed at assessing the feasibility, acceptability, and preliminary effects of the intervention.
Based on the findings from the pilot study, we plan to conduct an RCT at a later stage to evaluate the efficacy of the intervention compared with a control group.
Intervention
The intervention is text-based and consists of a series of texts organized into modules addressing different themes. All modules contain information about the relevant theme as well as questions for reflection. In several modules, participants are also asked to complete homework assignments, which they submit in writing to a therapist. The participant then receives written feedback from their personal therapist on the submitted assignments within 1-2 working days.
The intervention consists of two parts. The modules in the first part are provided to participants at one-week intervals.
The first part is mandatory and aims to increase participants' self-knowledge. It therefore consists of several modules focusing on increasing participants' knowledge and understanding of themselves, their individual circumstances, behavioral patterns, and difficulties. The underlying premise is that, in order to work with changes that may improve well-being, individuals first need to develop an in-depth understanding of their personal history and circumstances from a biopsychosocial perspective. One purpose of the mandatory part is therefore to enable participants, by the end of this part, to make an informed decision about what they would like to work on during the second part of the intervention.
The intervention is primarily individualized but, during the first part, will be supplemented by regular chat sessions with other participants enrolled in the intervention. The purpose of these chat sessions is to facilitate social peer support and provide participants with a sense of community and recognition through shared experiences. The chat sessions also provide an opportunity for participants to gain insight into other perspectives and to both receive and provide inspiration.
The intervention will be administered using the Stöd och Behandling (SOB) platform. SOB is currently used by several Swedish regions to provide internet-based support and treatment. The platform is free of charge for users.
Outcome measures will be assessed using digital questionnaires administrered through the same platform as the intervention.
- Conditions
- Autism
- Being tested
- Tailored And Transdiagnostic Internetbased intervention for Autistic adults
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored And Transdiagnostic Internetbased intervention for Autistic adultsBehavioural
The intervention is text-based and consists of a series of modules addressing different themes. All modules are provided to participants at one week intervals, and contain information about the relevant theme and questions for reflection. Participants are also asked to complete homework assignments, which they submit in writing to a therapist. The participant then receives written feedback from their personal therapist on the submitted assignments.
The intervention consists of two parts. The first part is mandatory and aims to increase participants' self-knowledge. It therefore consists of several modules focusing on increasing participants' knowledge and understanding of themselves, their individual circumstances, behavioral patterns, and difficulties.
The second part of the intervention consists of a number of optional modules. These modules aim both to further deepen participants' self-knowledge and to provide them with strategies to handle difficulties.
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving the intervention | Experimental | The participants participates in an 18 week internet based, individually tailored and transdiagnostic intervention aiming to enhance self-understanding and self-acceptance. Receives: Behavioral: Tailored And Transdiagnostic Internetbased intervention for Autistic adults |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Compassion
Self assessed Self-Compassion Scale
Measured: From enrollment until the end of the treatment at week 18, and at follow up at 3 and 6 months
Self-understanding
Self-assessed questionnaire on perceived self-understanding
Measured: From enrollment to the end of treatment at 18 weeks, and at follow up at 3 and 6 months
Self-acceptance
Self-assessed questionnaire on perceived self-acceptance
Measured: From enrollment until the end ot the intervention, and at 3 and 6 week follow-up
Secondary outcomes (1)
Sense of coherence
Self-assessed Sense of coherence questionnaire
Measured: At enrollment and at the end of the intervention at 18 weeks, and follow up at 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start1 Apr 2027 (estimated)
- Primary completion30 Aug 2028 (estimated)
- Study completion30 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Collaborators
- Örebro University, Sweden
- Responsible party
- Principal investigator, Britta Westerberg, Örebro University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07840261
- Sponsor's protocol ID
- 26RS4911
- Other IDs
- OLL-1041469
- Acronym
- TINA
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored and Transdiagnostic Internetbased Intervention for Autistic Adults
- ClinicalTrials.gov ID
- NCT07840261
- Acronym / sponsor ID
- TINA / 26RS4911
- Conditions
- Autism
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Collaborators
- Örebro University, Sweden
- Study start
- 1 Apr 2027 (estimated)
- Primary completion
- 30 Aug 2028 (estimated)
- Study completion
- 30 Aug 2028 (estimated)
- First posted
- 25 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The number of individuals receiving an autism diagnosis is increasing, particularly among individuals without co-occurring intellectual disability. This group does not always present with stereotypically autistic characteristics. Instead, the cognitive mechanisms underlying autistic functioning often manifest in less apparent difficulties, such as difficulties with self-acceptance, low self-esteem, stress-related problems, low energy, or anxiety. At the same time, this group is highly heterogeneous in terms of abilities and difficulties, and consequently, their needs also vary.
Over the past decades, it has become increasingly evident that autistic adults have substantial needs for support for psychological distress, while healthcare services have difficulties meeting these needs. This is likely due to a combination of limited resources and a lack of adapted and accessible interventions.
Providing psychological treatment via the internet may be one way of increasing access to healthcare for this population. Internet-based interventions have been shown to be effective in treating mental health problems in other patient populations, and the internet-based format may be well suited to the needs and preferences commonly reported by autistic individuals.
Within this project, we are developing an internet-based treatment for autistic adults aimed at increasing individuals' understanding of themselves and their difficulties, as well as improving self-esteem and self-acceptance. In the longer term, we hope that the treatment may also contribute to improved quality of life and sense of coherence, as well as reduced levels of anxiety and depression.
The treatment is intended for autistic adults experiencing some form of psychological distress. It consists of text-based modules, and participants complete exercises with the support of an individual therapist who guides them through the treatment. If the treatment proves to be effective, our hope is that it can be implemented within Swedish habilitation services as an alternative to face-to-face psychological treatment.
Detailed description
Aim and objectives
This study aims to investigate the effects of an individualized internet-based intervention for adults with autism who experience some form of distress that is wholly or partly related to their disability. The intervention aims to increase participants' understanding of themselves from a biopsychosocial perspective, provide them with strategies to manage difficulties associated with autism, and promote greater self-acceptance and self-compassion. In the longer term, the intervention is expected to contribute to improved quality of life and sense of coherence.
Research questions
In this initial pilot study, we aim to investigate the feasibility of the intervention. Specifically, we will examine whether the intervention can be delivered as intended, whether participants understand its content, whether the internet-based platform functions as intended, whether the selected outcome measures are appropriate, whether the observed variability in outcome measures is adequate, and whether participant attrition is acceptable. The findings from this pilot study may also inform a future power analysis for a randomized controlled trial (RCT).
Methods Design
The first planned study is a pilot study with a pre-post design aimed at assessing the feasibility, acceptability, and preliminary effects of the intervention.
Based on the findings from the pilot study, we plan to conduct an RCT at a later stage to evaluate the efficacy of the intervention compared with a control group.
Intervention
The intervention is text-based and consists of a series of texts organized into modules addressing different themes. All modules contain information about the relevant theme as well as questions for reflection. In several modules, participants are also asked to complete homework assignments, which they submit in writing to a therapist. The participant then receives written feedback from their personal therapist on the submitted assignments within 1-2 working days.
The intervention consists of two parts. The modules in the first part are provided to participants at one-week intervals.
The first part is mandatory and aims to increase participants' self-knowledge. It therefore consists of several modules focusing on increasing participants' knowledge and understanding of themselves, their individual circumstances, behavioral patterns, and difficulties. The underlying premise is that, in order to work with changes that may improve well-being, individuals first need to develop an in-depth understanding of their personal history and circumstances from a biopsychosocial perspective. One purpose of the mandatory part is therefore to enable participants, by the end of this part, to make an informed decision about what they would like to work on during the second part of the intervention.
The intervention is primarily individualized but, during the first part, will be supplemented by regular chat sessions with other participants enrolled in the intervention. The purpose of these chat sessions is to facilitate social peer support and provide participants with a sense of community and recognition through shared experiences. The chat sessions also provide an opportunity for participants to gain insight into other perspectives and to both receive and provide inspiration.
The intervention will be administered using the Stöd och Behandling (SOB) platform. SOB is currently used by several Swedish regions to provide internet-based support and treatment. The platform is free of charge for users.
Outcome measures will be assessed using digital questionnaires administrered through the same platform as the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants receiving the intervention | Experimental | Behavioral: Tailored And Transdiagnostic Internetbased intervention for Autistic adultsThe participants participates in an 18 week internet based, individually tailored and transdiagnostic intervention aiming to enhance self-understanding and self-acceptance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adults (>18 years) with a diagnosis of autism without intellectual disability who experience some form of difficulty or psychological distress related to their autism diagnosis.
Key exclusion criteria (1 listed)
- intellectual disability, severe anxiety, severe depression, psychosis, suicidal behavior, suicide risk, or ongoing psychological treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored And Transdiagnostic Internetbased intervention for Autistic adultsThe intervention is text-based and consists of a series of modules addressing different themes. All modules are provided to participants at one week intervals, and contain information about the relevant theme and questions for reflection. Participants are also asked to complete homework assignments, which they submit in writing to a therapist. The participant then receives written feedback from their personal therapist on the submitted assignments. The intervention consists of two parts. The first part is mandatory and aims to increase participants' self-knowledge. It therefore consists of several modules focusing on increasing participants' knowledge and understanding of themselves, their individual circumstances, behavioral patterns, and difficulties. The second part of the intervention consists of a number of optional modules. These modules aim both to further deepen participants' self-knowledge and to provide them with strategies to handle difficulties. | Behavioural | Participants receiving the intervention |
Primary outcome
Self-Compassion
Time frame: From enrollment until the end of the treatment at week 18, and at follow up at 3 and 6 months
Self assessed Self-Compassion Scale
Self-understanding
Time frame: From enrollment to the end of treatment at 18 weeks, and at follow up at 3 and 6 months
Self-assessed questionnaire on perceived self-understanding
Self-acceptance
Time frame: From enrollment until the end ot the intervention, and at 3 and 6 week follow-up
Self-assessed questionnaire on perceived self-acceptance
1 secondary outcome
Sense of coherence
Time frame: At enrollment and at the end of the intervention at 18 weeks, and follow up at 3 and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored And Transdiagnostic Internetbased intervention for Autistic adults in people with Autism, run by Region Örebro County at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Britta Westerberg, Med. dr (0046767672800, britta.westerberg@regionorebrolan.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Compassion (time frame: From enrollment until the end of the treatment at week 18, and at follow up at 3 and 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.