Tailored and Transdiagnostic Internetbased Intervention for Autistic Adults (TINA)
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Britta Westerberg, Med. dr
- Telefonnummer: 0046767672800
- E-post: britta.westerberg@regionorebrolan.se
Studieorter
-
-
-
Örebro, Sverige
- Vuxenhabiliteringen, Region Örebro Län
-
Kontakt:
- Britta Westerberg, Med. dr
- Telefonnummer: 0046767672800
- E-post: britta.westerberg@regionorebrolan.se
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Self-Compassion
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Sense of coherence
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 26RS4911
- OLL-1041469 (Annat bidrag/finansieringsnummer: Region Örebro County)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .