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Not yet recruitingNCT07840261TINAUpdated Sep 25, 2026

Tailored and Transdiagnostic Internetbased Intervention for Autistic Adults

An interventional study of Tailored And Transdiagnostic Internetbased intervention for Autistic adults in Autism, sponsored by Region Örebro County. Not yet recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Region Örebro County · Not applicable, Interventional, and Treatment

Updated Sep 25, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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.

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.

02

Conditions studied

  • Autism

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03

In context

Autistic Disorder

1,030 studies on the registry are indexed under Autistic Disorder; 266 are open to participants now.

This study's planned enrollment of 25 is below the median of 49 across 811 interventional studies indexed under Autistic Disorder.

Browse Autistic Disorder studies →

Lead sponsor

Region Örebro County is the lead sponsor of 124 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • intellectual disability, severe anxiety, severe depression, psychosis, suicidal behavior, suicide risk, or ongoing psychological treatment.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • Experimental
    Participants receiving the intervention

    The participants participates in an 18 week internet based, individually tailored and transdiagnostic intervention aiming to enhance self-understanding and self-acceptance.

    Behavioral: Tailored And Transdiagnostic Internetbased intervention for Autistic adults

Interventions

  • BehavioralTailored And Transdiagnostic Internetbased intervention for Autistic adults

    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.

06

What researchers measure

Primary outcomes

  1. Self-Compassion

    Self assessed Self-Compassion Scale

    Time frame: From enrollment until the end of the treatment at week 18, and at follow up at 3 and 6 months

  2. Self-understanding

    Self-assessed questionnaire on perceived self-understanding

    Time frame: From enrollment to the end of treatment at 18 weeks, and at follow up at 3 and 6 months

  3. Self-acceptance

    Self-assessed questionnaire on perceived self-acceptance

    Time frame: 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

    Time frame: At enrollment and at the end of the intervention at 18 weeks, and follow up at 3 and 6 months

07

Study locations

1 site
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Apr 2027; primary completion for Aug 2028, 16 months later.

Of 354 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 planned 16 months is below that.

Counting every sponsor, half of 366 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.

Registered
Sep 18, 2026
First posted
Sep 25, 2026
StartEst.
Apr 1, 2027
Primary completionEst.
Aug 30, 2028
CompletionEst.
Aug 30, 2028
Last update
Sep 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07840261
Collaborators
Örebro University, Sweden
Responsible party
Britta Westerberg (Med. Dr, Örebro University, Sweden) — Principal investigator
First posted
Sep 25, 2026
Start date
Apr 1, 2027 (estimated)
Primary completion
Aug 30, 2028 (estimated)
Completion
Aug 30, 2028 (estimated)
Last update
Sep 25, 2026

Study contacts

Britta Westerberg, Med. dr
Contact
britta.westerberg@regionorebrolan.se
0046767672800

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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