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Internet-based Treatment for Adults With Autism Spectrum Disorder (iALMA) (iALMA)

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ClinicalTrials.gov Identifier: NCT03570372
Recruitment Status : Not yet recruiting
First Posted : June 27, 2018
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
Fredrik Holländare, Region Örebro County

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 raising the quality of life and improving the mental health of 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 and symptoms of depression and anxiety. Participants in the intervention group receives a 37 session 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.


Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: Internet-based treatment for adults with autism spectrum Behavioral: Psychoeducation about autism spectum disorder Early Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Internet-based Treatment for Adults With Autism Spectrum Disorder (iALMA)
Estimated Study Start Date : August 1, 2018
Estimated Primary Completion Date : May 30, 2020
Estimated Study Completion Date : May 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention group
36 week internet-based CBT with therapist support. Regular online group discussions.
Behavioral: Internet-based treatment for adults with autism spectrum
Internet-based CBT. The intervention includes 36 modules focusing on: Psychoeducation, individual goal setting, behavioral change, management strategies, mindfulness techniques, stress management, sleep techniques, information about societal rights.

Active Comparator: Control group
Reads 2 books about Autism Spectrum Disorder (ASD)
Behavioral: Psychoeducation about autism spectum disorder
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.




Primary Outcome Measures :
  1. Change in life quality [ Time Frame: Change from Baseline, at 9 weeks, at 18 weeks, at 6 months and at 12 months ]
    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

  2. Change in depressive and anxiety symptoms [ Time Frame: Change from Baseline, at 9 weeks, at 18 weeks, at 6 months and at 12 months ]
    Possible interaction effect between group and time in respect of differences in Depressive and anxiety symptoms of the intervention group and the control group between pre, post and follow-up measurement. Depression and anxiety symptoms will be measured using HADS


Secondary Outcome Measures :
  1. Change in knowledge of ASD [ Time Frame: Change from Baseline, at 9 weeks and at 18 weeks ]
    Possible interaction effect between group and time in respect of differences in knowledge about ASD of the intervention group and the control group between pre, post and follow-up measurement. Change in knowledge of ASD will be measured using using "Autism Knowledge questionnaire", which is a questionnaire created for the project.

  2. Subjective experience of ICBT [ Time Frame: At 19 weeks ]
    The subjective experience of participating in an internet based treatment will be qualitatively evaluated using semi structured interview.

  3. Content of communication [ Time Frame: At 20 weeks ]
    Thematic content of the written communication between participant and therapist will be assessed using content analysis.

  4. Correlation between schizotypal traits using SPQ and effect in quality of Life using BBQ [ Time Frame: Correlation are measured from Baseline, at 9 weeks and at 18 weeks ]
    Potential correlation between schizotypal traits using the questionnaire Schizotypal traits questionnaire (SPQ) and effect in quality of Life using Brunnsviken Brief Quality of life questionnaire (BBQ)



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have ASD diagnosis
  • Must have normal IQ
  • Must be able to understand and read swedish

Exclusion Criteria:

  • high risk of suicide
  • psychosis
  • inability to fill out forms and answer questions on the internet
  • inability to read and understand the Swedish language
  • reported threatening behavior
  • ongoing psychotherapy with CBT or social behavior training
  • mental development disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03570372


Contacts
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Contact: Britta Westerberg, Psychologist +46767672800 britta.westerberg@regionorebrolan.se
Contact: Fredrik Holländare, Med. dr +46737600700 fredrik.hollandare@regionorebrolan.se

Locations
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Sweden
Region Örebro County Not yet recruiting
Örebro, Örebro County, Sweden, 70217
Contact: Britta Westerberg    +46767672800    britta.westerberg@regionorebrolan.se   
Sponsors and Collaborators
Örebro County Council
Investigators
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Principal Investigator: Britta Westerberg Region Örebro County

Publications:
Ware, JE., Kosinski, M. & Gandek, B. (2005). SF-36 health survey: Manual and interpretation guide. Lincoln: Quality Metric, Inc.
Shulte, D., (2005). Zeitschrift für Klinische Psychologie und Psychotherapie, 34, 176-188.
Sheehan, 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
Rydén, E. & Bejerot, S. (2008). Autism Spectrum Disorders in an adult Psychiatric Population. A Naturalistic Cross-Sectional controlled study. Clinical Neuropsychiatry, 5, 1, 13-21.
Ramsay, 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
Raine, 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.
Howlin, P. (2003). Autism preparing for adulthood. London: Routledge.
Howlin, P. (2000). Outcome in adult life for more able individuals with autism or Asperger syndrome. Autism, 4, 63-83
Guy, W. (1976). The Clinical Global Impression Scale. ECDEU Assessment Manual for Psychopharmacology. 218-222
Gaus, LV. (2007). Cognitive-Behavioral Therapy for Adult Asperger Syndrome. New York, NY: Guilford Press.
Frisch, 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.
Attwood T. (2008). Den kompletta guiden till Aspergers syndrom. Stockholm: Cura.

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Responsible Party: Fredrik Holländare, Doctor of Philosophy, Region Örebro County
ClinicalTrials.gov Identifier: NCT03570372     History of Changes
Other Study ID Numbers: 17RS4920
First Posted: June 27, 2018    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fredrik Holländare, Region Örebro County:
Life quality
ASD
Internet based treatment
Autism
ICBT

Additional relevant MeSH terms:
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Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders