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Efficacy of individual, manualized short-term cognitive behavioral therapy for adults within the autism spectrum: A randomized controlled trial

Efficacy of individual, manualized short-term cognitive behavioral therapy for adults within the autism spectrum: A randomized controlled trial - CBT-ASC

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00027914
Enrollment
236
Registered
2025-04-11
Start date
2025-04-24
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

F84.0 F84.1 F84.5

Interventions

Group 1: Enhanced Standard Care (ESC): standard treatment by medical, psychiatric or psychological practitioners supplemented by comprehensive autism-specific diagnostics as well as subsequent autism-

Sponsors

Humboldt-Universität zu Berlin
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: - diagnosis of autism spectrum disorder (ICD-10: early childhood autism (F84.0), atypical autism (F84.1) or Asperger syndrome (F84.5)) - Presence of an external person (relatives, friends, colleagues) who completes the Social Responsiveness Scale (SRS) - IQ = 80 (vocabulary test, WST) - Sufficient knowledge of the German language to participate in psychotherapy in German and to complete questionnaires - Ability to consent and written informed consent, or consent by legal guardian - No severe reading or writing impairments - no or stable pharmacotherapy (for at least 6 weeks before the first measurement date; no planned change of medication class during the study; dose adjustments are possible) - Consent to audio and video recordings of therapy sessions - Comorbid mental disorders are permitted (except see exclusion criteria)

Exclusion criteria

Exclusion criteria: - psychiatric comorbidities: florid schizophrenia (F20.x), acute delusional disorder (F22.x), acute transient psychotic disorder (F23.x), induced delusional disorder (F24), schizoaffective disorder (F25. x), acute other or unspecified non-organic psychotic disorder (F28, F29), acute mania or bipolar affective disorder (F30.x, F31.x, F34.x), acute major depression (F32.2, F32.3, F33.2, F33.3), acute suicidality - primary comorbid disorder in urgent need of treatment - substance abuse / substance dependence within the last 12 months (F1x, except F17) - uncorrected, severe visual or hearing impairment - neurological disorders or medical disease factors that interfere with study participation - participation in individual and/or group psychotherapy (current or within the last 6 months prior to study entry); inclusion possible after completion of treatment - psychiatric day clinic / inpatient stay at the start of therapy; inclusion possible after completion of seminredidential / inpatient treatment

Design outcomes

Primary

MeasureTime frame
The primary endpoint examined is the adjustment of social responsiveness and cognition over the measurement time points. The adjustment of social responsiveness and cognition is measured using the Social Responsiveness Scale (Bölte, Poustka, & Constantino, 2008). This is an external assessment procedure that is completed by a person close to the patient (e.g. relatives, friends, colleagues). The measurement times are: - T1: immediately before therapy or ESC - T2: at the time of completion of therapy (usually 4 months after the start of therapy) or 4 months after randomization - T3: at 3 months after completion of therapy or 7 months after randomization - T4: To examine the long-term stability of possible changes, study participants who were randomized to the intervention group as part of the study are invited and examined again one year after the end of therapy. For study participants who were assigned to the ESC group, an additional examination at T4 will not take place.

Secondary

MeasureTime frame
- Change in individual quality of life, measured with the WHO-QOL-BREF (Whoqol Group, 1998) - General symptom burden and change, measured with the Global Severity Index of the Brief Symptom Inventory (BSI; Derogatis & Melisaratos, 1983) and the Clinical Global Impression (CGI; Guy, 1976) - Depressiveness, measured with the Beck Depression Inventory - II (BDI-II; Beck, Steer, & Brown, 1996) - Social anxiety, measured with the Liebowitz Social Anxiety Scale (LSAS; Stangier & Heidenreich, 2005) - Self-esteem, measured with the Multidimensional Self-Esteem Scale (MSWS; Schütz & Rentzsch, 2020), and psychological flourishing, measured with the Flourishing Scale (Esch, Jose, Gimpel, von Scheidt, & Michalsen, 2013) - Social support, measured with the Brief Social Support Scale (Beutel et al., 2017) - Work and social adjustment, measured with the Work and Social Adjustment Scale, WSAS (Heissel et al., 2021) - Acceptance of the autism diagnosis measured with a German translation of the Acceptance and Action Questionnaire (AAQ-II; Bond et al., 2011), modified according to Agius et al. (2024) - Treatment-related patient satisfaction measured with the Questionnaire for the Measurement of Patient Satisfaction (ZUF-8; Schmidt & Wittmann, 2002) - Treatment credibility questionnaire, adapted from Borkovec and Nau (1972) and Agius et al. (2024)

Countries

Germany

Contacts

Public ContactIsabel Dziobek

Humboldt-Univiersität zu Berlin

isabel.dziobek@hu-berlin.de+49 3020934903

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 29, 2026