Online PTSD Treatment for Young People and Carers - Case Series
NCT ID: NCT03935035
Last Updated: 2019-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
6 participants
INTERVENTIONAL
2019-04-01
2019-12-31
Brief Summary
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The researchers are therefore developing a website and smart-phone App that will improve accessibility of this treatment by allowing trained therapists to deliver CT-PTSD over the internet (iCT) to young people (12-17 years old) with PTSD. This study aims to provide an initial evaluation of iCT. This will be done by running an uncontrolled case series with 6 young people.
The objectives of the case series are to: to gauge acceptability of the programme to young people, carers, and therapists; to measure adherence to the programme; to test the battery of measures for acceptability; and to obtain estimates of clinical change.
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Detailed Description
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An uncontrolled case series will be run with N=6 young patients. Young people who are referred to the South London and Maudsley NHS Foundation Trust CAMHS service, and who meet the eligibility criteria, will be invited to take part in the case series. After both the young person and their carer or parent have provided informed consent (or assent), they will complete several baseline assessment measures. These measures will be completed at a face-to-face meeting in the Tier 4 National and Specialist Trauma, Anxiety and Depression (TAD) NHS clinic, and online. The young person and family will meet the young person's therapist face-to-face at this initial assessment meeting. After assessment, the young person that will be treated remotely using iCT for up to 12 weeks.
This treatment will include regular (at least weekly) telephone contact with the therapist, and other contact with the therapist during the week using a messaging function within the iCT App. The young person will be asked to complete a mood rating and a brief 8-item questionnaire about PTSD symptoms once a week during treatment: this mirrors what happens during standard face-to-face care in the TAD NHS clinic. At mid treatment, the young person will be asked to complete one additional 25-item questionnaire about thoughts related to trauma. Risk monitoring including monitoring of adverse events will be carried out during weekly phone calls.
Post treatment, the young person will attend the TAD NHS clinic for a face-to-face clinical interview and will complete a questionnaire pack online. At this meeting, the young person will complete feedback ratings on the acceptability of the design of online treatment modules using 4 simple 0-10 scales (about the overall design appeal, ease-of-use, comprehension, and likelihood of recommending the program to a friend with similar problems). The young person will be interviewed about their experience of using the iCT program (an "exit interview"). Acceptability of the questionnaire battery will be assessed by asking young people to complete an end-of-treatment rating using a 0-100 scale. The young people's parents or carers will also take part in a clinical interview about the young person, will complete a questionnaire pack online, and will be invited to take part in an interview about their experience as a parent or carer of using the iCT program.
N=6 young people will be treated as part of this case series. Young people's and their parents' qualitative feedback on the acceptability of the iCT programme will be reported using data from the exit interviews and from the acceptability rating scales. Averse events during therapy will also be reported. Reliable Clinical Change on a standardised questionnaire of PTSD symptoms (the CPSS-5) will be reported as a preliminary signal of clinical effect. Reliable Clinical Improvement is shown by a reduction of 8 points on the CPSS-5. Acceptability of the outcome measures will be gauged by scrutinising completion rates.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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internet-Cognitive Therapy for PTSD
This is a single-arm study. All participants will receive the same therapist supported, internet-delivered intervention.
internet-delivered Cognitive Therapy for PTSD (iCT)
Participants will receive 10 hours of Cognitive Therapy for PTSD over 12 weeks, with a baseline assessment at the beginning and follow up interview at the end of treatment. The treatment consists of online modules (9 core modules, 11 optional modules and parent/carer modules) and a weekly phone call with a qualified and trained therapist.
Interventions
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internet-delivered Cognitive Therapy for PTSD (iCT)
Participants will receive 10 hours of Cognitive Therapy for PTSD over 12 weeks, with a baseline assessment at the beginning and follow up interview at the end of treatment. The treatment consists of online modules (9 core modules, 11 optional modules and parent/carer modules) and a weekly phone call with a qualified and trained therapist.
Eligibility Criteria
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Inclusion Criteria
* Main presenting problem is PTSD and there is a not a co-morbid problem that would preclude treatment of PTSD.
* PTSD symptoms related to a single trauma
* Participant has access to compatible smartphone and larger computing device (e.g. laptop, desktop computer, iPad) with internet access.
* Participant is proficient in speaking and writing in the English language, sufficient to participate in treatment without an interpreter.
Exclusion Criteria
* Intellectual disability assessed by clinical interview with parents / carers
* Pervasive developmental disorder or neurodevelopmental disorder assessed by clinical interview with parents / carers
* Other psychiatric diagnosis that requires treatment before PTSD, determined by clinical interview and questionnaires
* Moderate to high risk to self assessed in clinical interview
* Ongoing trauma-related threat assessed in clinical interview
* Started treatment with psychotropic medication, or changed medication, within the last 2 months, assessed in clinical interview
* Currently receiving another psychological treatment, assessed in interview
* Have already received Trauma Focused CBT in relation to the same traumatic event that the young person is currently seeking treatment for.
12 Years
17 Years
ALL
No
Sponsors
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Medical Research Council
OTHER_GOV
South London and Maudsley NHS Foundation Trust
OTHER
King's College London
OTHER
Responsible Party
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Principal Investigators
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Patrick Smith, PhD
Role: PRINCIPAL_INVESTIGATOR
King's College London
Locations
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King's College London/ South London and Maudsley NHS Foundation Trust
London, , United Kingdom
University of East Anglia/ Norfolk and Suffolk NHS Foundation Trust
Norwich, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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Foa EB, Johnson KM, Feeny NC, Treadwell KR. The child PTSD Symptom Scale: a preliminary examination of its psychometric properties. J Clin Child Psychol. 2001 Sep;30(3):376-84. doi: 10.1207/S15374424JCCP3003_9.
Goodman R. Psychometric properties of the strengths and difficulties questionnaire. J Am Acad Child Adolesc Psychiatry. 2001 Nov;40(11):1337-45. doi: 10.1097/00004583-200111000-00015.
McKinnon A, Smith P, Bryant R, Salmon K, Yule W, Dalgleish T, Dixon C, Nixon RD, Meiser-Stedman R. An Update on the Clinical Utility of the Children's Post-Traumatic Cognitions Inventory. J Trauma Stress. 2016 Jun;29(3):253-8. doi: 10.1002/jts.22096. Epub 2016 May 18.
Perrin, S., Meiser-Stedman, R., & Smith, P. (2005). The Children's Revised Impact of Event Scale (CRIES): validity as a screening instrument for PTSD. Behavioural and Cognitive Psychotherapy, 33(4), 487-498.
Pynoos, R. S., Weathers, F. W., Steinberg, A. M., Marx, B. P., Layne, C. M., Kaloupek, D. G., Schnurr, P. P., Keane, T. M., Blake, D. D., Newman, E., Nader, K. O., & Kriegler, J. A. (2015). Clinician-Administered PTSD Scale for DSM-5 - Child/Adolescent Version.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form: Assent Form for participants aged 12-15
Document Type: Informed Consent Form: Consent Form for participants aged 16-17
Document Type: Informed Consent Form: Parental consent form for parental participation
Document Type: Informed Consent Form: Parental consent form for participants aged 12-15
Related Links
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Link to Perrin, Meiser-Stedman, \& Smith, (2005). The Children's Revised Impact of Event Scale (CRIES): validity as a screening instrument for PTSD
Link to Pynoos et al., (2015). Clinician-Administered PTSD Scale for DSM-5 - Child/Adolescent Version
Chorpita, B. F., Ebesutani, C., \& Spence, S. H. (2014). Revised children's anxiety and depression scale user's guide. Unpublished Users Guide, University of California, Los Angeles. http://www. childfirst. ucla. edu/RCADSUsersGuide20140711.pdf.
Other Identifiers
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MR/P017355/1
Identifier Type: -
Identifier Source: org_study_id
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