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Effectiveness of smartphone app-based behavioral activation for adults wit h autism spectrum disorder

Effectiveness of smartphone behavioral activation for autism spectrum dis orders in adults: Multicenter, randomized, open-label, parallel group comparison trial - INCLUSION (INternet-based Cognitive behavioral therapy as Learning Units for Social IntegratiON) trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1040250116
Enrollment
98
Registered
2025-10-15
Start date
2025-12-18
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary: Autism Spectrum Disorder (ASD) Symptoms: Depressive Symptoms, Anxiety Symptoms Autism Spectrum Disorder (ASD) , Depressive Symptoms, Anxiety Symptoms

Interventions

Behavioural activation psychotherapy will be delivered for six weeks via a smartphone application. In-app questionnaires will be collected every week from 0 to 6, and addictionally week 9, and 12. Dur

Sponsors

Yamada Atsurou
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Diagnosed with autism spectrum disorder (ASD). 2. Aged18 to 59 years at the time of consent. 3. Engaged in activities aimed at employment at the time of consent (e g., continuous employment support Type A or Type B, vocational transition support or employment retention support service, or receiving employment counseling). 4. Able to use a smartphone to complete electronic questionnaires. 5. Uses a smartphone in daily life and can install applications. 6. If receiving pharmacotherapy in psychosomatic medicine or psychiatry, able to continue without changing the regimen (drug type or dose) during study participation. 7. Has a Patient Health Questionnaire-9 (PHQ-9) total score of 5 to 14 on the web-based screening.

Exclusion criteria

Exclusion criteria: 1. Has significant difficulty reading or writing Japanese. 2. Has a comorbid, uncontrolled severe psychiatric disorder (schizophrenia, bipolar disorder, or severe major depressive disorder) that make s participation inappropriate. 3. If receiving care in psychosomatic medicine or psychiatry, the treating physician judges participation to be inappropriate. 4. Has a diagnosed intellectual disability with an official Rehabilitation Handbook. 5. Is using the Seikatsu Kaigo (day activity or life care) service. 6. Has previously received behavioral activation. 7. On the web-based screening, has a PHQ-9 tot al score 10 to 14 and a score 2 or 3 on item 9 (suicidal ideation: more than half the days or nearly every day).

Design outcomes

Primary

MeasureTime frame
Change from baseline in PHQ-9 score at Week 6

Secondary

MeasureTime frame
Change from baseline in GAD-7 total score at Week 6 Change from baseline in CBT skill (behavioural actvation only) at Week 6 Change from baseline in the presenteeism scale at Week 6 Change in employment status at Weeks 6 and 12 Change from baseline in PHQ-9 total score at Week 12

Contacts

Public ContactRyo Tsujino

Department of Psychiatry andCognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan

dsottoei@gmail.com+81-52-851-5511

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026