Tailored and Transdiagnostic Internetbased Intervention for Autistic Adults (TINA)

September 18, 2026 updated by: Britta Westerberg, Region Örebro County

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
From enrollment until the end of the treatment at week 18, and at follow up at 3 and 6 months
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
From enrollment to the end of treatment at 18 weeks, and at follow up at 3 and 6 months
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
From enrollment until the end ot the intervention, and at 3 and 6 week follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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

Self-assessed Sense of coherence questionnaire
At enrollment and at the end of the intervention at 18 weeks, and follow up at 3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Region Örebro County

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Örebro University, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 18, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 26RS4911
  • OLL-1041469 (Other Grant/Funding Number: Region Örebro County)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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