Internet-based Treatment for Adults With Autism Spectrum Disorder.
MILAS
1 other identifier
interventional
84
1 country
1
Brief Summary
The group of patients diagnosed with Autism spectrum disorder (ASD) is increasing and so is the need for new and effective treatment methods. ASD is characterized, among other things, by difficulties in social interaction and communication. These difficulties often affects their quality of life and causes a risk of developing social anxiety or other forms of mental illness, which often leads to isolation and may cause difficulties in participating in regular face- to- face psychological treatment. Although research shows that group therapy is favorable for this group of patients, many with ASD refrain from group-treatment due to social anxiety or difficulties with public transport. In order to increase the availability of evidence based psychological treatment for these patients, it seems important to be able to offer a web-based treatment option, with the ability to participate in online group sessions. The aim of the study is to investigate whether Internet-based CBT is an effective method of improving the quality of life and sense of coherence and decreasing symtoms of anxiety and depression among adults with ASD. A randomized controlled study design will be used. Assessment will be conducted through video interviews, recruiting 84 patients with ASD and normal intellectual abilities. Symptoms of depression and other forms of psychopathology will be assessed through MINI-7 interviews. Primary outcome measures are quality of life. Participants in the intervention group receives a 18 week blended treatment combining individual ICBT delivered through a treatment platform called Stöd och Behandling (SOB) with the opportunity to participate in regular group discussions delivered through a discussion forum online. Participants in the control groups are offered self-studies through psycho educative books about ASD. Data will be collected at baseline, mid-treatment, post-treatment and after six and 12 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2018
CompletedFirst Posted
Study publicly available on registry
June 27, 2018
CompletedStudy Start
First participant enrolled
August 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2020
CompletedApril 4, 2025
April 1, 2025
1.8 years
January 29, 2018
April 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in life quality
Possible interaction effect between group and time in respect of differences in quality of life of the intervention group and the control group between pre, post and follow-up measurement
Change from Baseline, at 9 weeks, at 18 weeks, at 6 months and at 12 months
Change in Sense of coherence
Possible interaction effect between group and time in respect of differences in Sense of coherence of the intervention group and the control group between pre, post and follow-up measurement. Sense of coherence will be measured using SOC-13 questionnaire.
Change from Baseline, at 18 weeks, at 6 months and at 12 months
Secondary Outcomes (3)
Change in depressive and anxiety symptoms
Change from Baseline, at 9 weeks, at 18 weeks, at 6 months and at 12 months
Subjective experience of ICBT
At 19 weeks
Content of communication
At 20 weeks
Study Arms (2)
Intervention group
EXPERIMENTAL18 week internet-based CBT with therapist support. Regular online group discussions.
Control group
ACTIVE COMPARATORReads 2 books about Autism Spectrum Disorder (ASD)
Interventions
Internet-based CBT. The intervention includes 18 modules focusing on: Psychoeducation, individual goal setting, behavioral change, management strategies and stress management
Self-studies by reading the book "What does the disability mean ?: Living with autism / Asperger syndrome. Project Empowerment "(2004), by Norrö \& Swing Åström, as well as a book of biographical stories of people who have ASD. The first book will be read during the first half of the project, and the second will be in the second half.
Eligibility Criteria
You may qualify if:
- Must have ASD diagnosis
- Must have normal IQ
- Must be able to understand and read swedish
You may not qualify if:
- high risk of suicide
- psychosis
- inability to fill out forms and answer questions on the internet
- inability to read and understand the Swedish language
- ongoing psychotherapy with CBT or social behavior training
- mental development disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Örebro County Councillead
- Örebro University, Swedencollaborator
- Regional Research Council Mid Swedencollaborator
- Fredrik och Ingrid Thurings Stiftelsecollaborator
- Stiftelsen Professor Bror Gadelius Minnesfondcollaborator
Study Sites (1)
Region Örebro County
Örebro, Örebro County, 70217, Sweden
Related Publications (27)
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
PMID: 6880820BACKGROUNDWare, JE., Kosinski, M. & Gandek, B. (2005). SF-36 health survey: Manual and interpretation guide. Lincoln: Quality Metric, Inc.
BACKGROUNDEuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.
PMID: 10109801BACKGROUNDShulte, D., (2005). Zeitschrift für Klinische Psychologie und Psychotherapie, 34, 176-188.
BACKGROUNDSheehan, D.V., Lecrubier, Y., Sheehan, K., Harnett, J., Weiller, E., Keskiner, A., Schinka, J., Knapp, E., Sheehan, M. F. & Dunbar, G. C. (1997). Reliability and validity of the Mini International Neuropsychiatric Interview (M.I.N.I.) according to the SCID-P. European Psychiatry, Vol 12(5), 1997, 232-241
BACKGROUNDRydén, E. & Bejerot, S. (2008). Autism Spectrum Disorders in an adult Psychiatric Population. A Naturalistic Cross-Sectional controlled study. Clinical Neuropsychiatry, 5, 1, 13-21.
BACKGROUNDRozental A, Kottorp A, Boettcher J, Andersson G, Carlbring P. Negative Effects of Psychological Treatments: An Exploratory Factor Analysis of the Negative Effects Questionnaire for Monitoring and Reporting Adverse and Unwanted Events. PLoS One. 2016 Jun 22;11(6):e0157503. doi: 10.1371/journal.pone.0157503. eCollection 2016.
PMID: 27331907BACKGROUNDRichards D, Richardson T. Computer-based psychological treatments for depression: a systematic review and meta-analysis. Clin Psychol Rev. 2012 Jun;32(4):329-42. doi: 10.1016/j.cpr.2012.02.004. Epub 2012 Feb 28.
PMID: 22466510BACKGROUNDRamsay, JR., Brodkin, R. Cohen, ES. Listerud, MR. & Rostain, J. (2005). "Better Strangers": Using the Relationship in Psychotherapy for Adult Patients with Asperger Syndrome. Psychotherpy: Theory, Research, Practice, Training, 42, 483-93
BACKGROUNDRaine, A., & Benishay, D (1995). The SPQ-B: A Brief Screening Instrument for Schizotypal Personality Disorder. Journal of Personality Disorders: Vol. 9, No. 4, pp. 346-355.
BACKGROUNDMartin PJ, Sterne AL. Prognostic expectations and treatment outcome. J Consult Clin Psychol. 1975 Aug;43(4):572-6. doi: 10.1037/h0076886. No abstract available.
PMID: 1159154BACKGROUNDLarsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207. doi: 10.1016/0149-7189(79)90094-6. No abstract available.
PMID: 10245370BACKGROUNDKroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PMID: 11556941BACKGROUNDHowlin, P. (2003). Autism preparing for adulthood. London: Routledge.
BACKGROUNDHowlin, P. (2000). Outcome in adult life for more able individuals with autism or Asperger syndrome. Autism, 4, 63-83
BACKGROUNDHesselmark E, Plenty S, Bejerot S. Group cognitive behavioural therapy and group recreational activity for adults with autism spectrum disorders: a preliminary randomized controlled trial. Autism. 2014 Aug;18(6):672-83. doi: 10.1177/1362361313493681. Epub 2013 Oct 2.
PMID: 24089423BACKGROUNDGuy, W. (1976). The Clinical Global Impression Scale. ECDEU Assessment Manual for Psychopharmacology. 218-222
BACKGROUNDGaus, LV. (2007). Cognitive-Behavioral Therapy for Adult Asperger Syndrome. New York, NY: Guilford Press.
BACKGROUNDFrith U, Happe F. Autism: beyond "theory of mind". Cognition. 1994 Apr-Jun;50(1-3):115-32. doi: 10.1016/0010-0277(94)90024-8.
PMID: 8039356BACKGROUNDFrisch, MB., Cornell, Villanueva & Retzlaff. (1992). Clinical validation of the Quality of Life Inventory. A measure of life satisfaction for use in treatment planning and outcome assessment. Psychol Assess, 4, 92-101.
BACKGROUNDBejerot S, Eriksson JM, Mortberg E. Social anxiety in adult autism spectrum disorder. Psychiatry Res. 2014 Dec 15;220(1-2):705-7. doi: 10.1016/j.psychres.2014.08.030. Epub 2014 Aug 27.
PMID: 25200187BACKGROUNDBejerot S, Edman G, Anckarsater H, Berglund G, Gillberg C, Hofvander B, Humble MB, Mortberg E, Rastam M, Stahlberg O, Frisen L. The Brief Obsessive-Compulsive Scale (BOCS): a self-report scale for OCD and obsessive-compulsive related disorders. Nord J Psychiatry. 2014 Nov;68(8):549-59. doi: 10.3109/08039488.2014.884631. Epub 2014 Feb 25.
PMID: 24568661BACKGROUNDAttwood T. (2008). Den kompletta guiden till Aspergers syndrom. Stockholm: Cura.
BACKGROUNDAntonovsky A. The structure and properties of the sense of coherence scale. Soc Sci Med. 1993 Mar;36(6):725-33. doi: 10.1016/0277-9536(93)90033-z.
PMID: 8480217BACKGROUNDAndersen LM, Naswall K, Manouilenko I, Nylander L, Edgar J, Ritvo RA, Ritvo E, Bejerot S. The Swedish version of the Ritvo autism and asperger diagnostic scale: revised (RAADS-R). A validation study of a rating scale for adults. J Autism Dev Disord. 2011 Dec;41(12):1635-45. doi: 10.1007/s10803-011-1191-3.
PMID: 21327833BACKGROUNDWesterberg B, Jacobson K, Unenge Hallerback M, Bejerot S, Hollandare F. Communicative Behaviors in an Internet-Based Intervention for Individuals With Autism: Mixed Methods Analysis. J Med Internet Res. 2026 Feb 4;28:e76527. doi: 10.2196/76527.
PMID: 41637734DERIVEDKlang A, Westerberg B, Humble MB, Bejerot S. The impact of schizotypy on quality of life among adults with autism spectrum disorder. BMC Psychiatry. 2022 Mar 19;22(1):205. doi: 10.1186/s12888-022-03841-2.
PMID: 35305592DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Britta Westerberg
Region Örebro County
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor of Philosophy
Study Record Dates
First Submitted
January 29, 2018
First Posted
June 27, 2018
Study Start
August 1, 2018
Primary Completion
May 30, 2020
Study Completion
May 30, 2020
Last Updated
April 4, 2025
Record last verified: 2025-04