Online PTSD Treatment for Young People and Carers - Case Series

NCT03935035 | Unknown

• 1 other identifier: MR/P017355/1
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

Brief Summary

Post Traumatic Stress Disorder (PTSD) is prevalent and impairing in children and young people. Effective face to face treatments exist, including Cognitive Therapy for PTSD (CT-PTSD), developed by the researchers' group. However, few young people access effective treatments. 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.

Conditions

Post Traumatic Stress Disorder

Keywords

adolescents; internet-delivered; online; young people; trauma; cognitive therapy

Outcome Measures

Primary Outcomes (32)

• PTSD symptom scale: Clinician Administered PTSD Scale for Children and Adolescents (CAPS-CA-5, Pynoos et al., 2015)

  Clinician Administered. The time period covered is the past month. Items are rated 0-4 based on frequency and severity of symptoms (0=absent, 1= mild, 2=moderate, 3 = severe, 4 = extreme). PTSD diagnostic status is determined by first dichotomizing each symptom as "present" (if the symptom severity is rated 2 or higher) or "absent" (rated 0 or 1). Items pertain to the 4 criterion of PTSD outlined in the DSM-V; criterion B (items 1-5), criterion C (items 6-7), criterion D (items 8-14) and criterion E (items 15-20). PTSD may be diagnosed if the young person has at least one criterion B, one criterion C, two criterion D and two criterion E symptoms and if the disturbance has lasted for more than one month and causes clinically significant distress or functional impairment.

  Baseline

• PTSD symptom scale: using the Clinician Administered PTSD Scale for Children and Adolescents (CAPS-CA-5, Pynoos et al., 2015)

  Clinician Administered. The time period covered is the past month. Items are rated 0-4 based on frequency and severity of symptoms (0=absent, 1= mild, 2=moderate, 3 = severe, 4 = extreme). PTSD diagnostic status is determined by first dichotomizing each symptom as "present" (if the symptom severity is rated 2 or higher) or "absent" (rated 0 or 1). Items pertain to the 4 criterion of PTSD outlined in the DSM-V; criterion B (items 1-5), criterion C (items 6-7), criterion D (items 8-14) and criterion E (items 15-20). PTSD may be diagnosed if the young person has at least one criterion B, one criterion C, two criterion D and two criterion E symptoms and if the disturbance has lasted for more than one month and causes clinically significant distress or functional impairment.

  post-intervention (at 4 months)

• PTSD symptoms: Child Post Traumatic Stress Scale (CPSS-5; Foa et al. 2001)

  A self-report questionnaire with 27 items relating to the past one month. The first 20 items evaluate the frequency and severity of PTSD symptoms. Items are rated on a 5-point scale (0= not at all, 1 = \<once a week, 2= 2-3 times per week, 3 = 4-5 times a week, 4 = 6 or more times per week). The final 7 items evaluate functional impairment an are scored 1 ('Yes') or 0 ('No') with scores ranging from 0-7, greater scores indicate greater impairment. From the first part of the CPSS scores can range between 0-80 with higher scores indicating greater symptom severity. A score of 31 or higher indicates PTSD.

  Baseline

• PTSD symptoms: Child Post Traumatic Cognitions Inventory (CPTCI, McKinnon et al 2016)

  A self-report questionnaire with 10 items. The CPTCI measures PTSD symptoms since the traumatic event occurred, on a scale of 1-4 (1= don't agree at all, 2 = don't agree a bit, 3 = agree a bit, 4 = agree a lot). Scores range from 0-40 with greater scores indicating greater symptom severity. A total score of 16 or above is considered clinically significant.

  Baseline

• PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al 2005)

  A self-report questionnaire with 8 items (4 measuring intrusions, 4 measuring avoidance). The items assess symptoms over the past 7 days on a 4-point scale (0=not at all, 1= rarely, 3=sometimes, 5=often). Intrusion sub-scale is the sum of items 1,3,6 and 7. Avoidance sub-scale is the sum of items 2,4,5 and 8. Scores can range from 0-40 with greater scores indicating greater symptom severity. A total score of 17 or higher indicates PTSD.

  Baseline

• PTSD symptoms: Child Post Traumatic Cognitions Inventory (CPTCI, McKinnon et al 2016)

  A self-report questionnaire with 10 items. The CPTCI measures PTSD symptoms since the traumatic event occurred, on a scale of 1-4 (1= don't agree at all, 2 = don't agree a bit, 3 = agree a bit, 4 = agree a lot). Scores range from 0-40 with greater scores indicating greater symptom severity. A total score of 16 or above is considered clinically significant.

  Mid-Treatment (at 6 weeks)

• PTSD symptoms: Child Post Traumatic Stress Scale (CPSS-5; Foa et al. 2001)

  A self-report questionnaire with 27 items relating to the past one month. The first 20 items evaluate the frequency and severity of PTSD symptoms. Items are rated on a 5-point scale (0= not at all, 1 = \<once a week, 2= 2-3 times per week, 3 = 4-5 times a week, 4 = 6 or more times per week). The final 7 items evaluate functional impairment an are scored 1 ('Yes') or 0 ('No') with scores ranging from 0-7, greater scores indicate greater impairment. From the first part of the CPSS scores can range between 0-80 with higher scores indicating greater symptom severity. A score of 31 or higher indicates PTSD.

  Post-treatment (at 4 months)

• PTSD symptoms: Child Post Traumatic Cognitions Inventory (CPTCI, McKinnon et al 2016)

  A self-report questionnaire with 10 items. The CPTCI measures PTSD symptoms since the traumatic event occurred, on a scale of 1-4 (1= don't agree at all, 2 = don't agree a bit, 3 = agree a bit, 4 = agree a lot). Scores range from 0-40 with greater scores indicating greater symptom severity. A total score of 16 or above is considered clinically significant.

  Post-treatment (at 4 months)

• PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al 2005)

  A self-report questionnaire with 8 items (4 measuring intrusions, 4 measuring avoidance). The items assess symptoms over the past 7 days on a 4-point scale (0=not at all, 1= rarely, 3=sometimes, 5=often). Intrusion sub-scale is the sum of items 1,3,6 and 7. Avoidance sub-scale is the sum of items 2,4,5 and 8. Scores can range from 0-40 with greater scores indicating greater symptom severity. A total score of 17 or higher indicates PTSD.

  Post-treatment (at 4 months)

• PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al 2005)

  A self-report questionnaire with 8 items (4 measuring intrusions, 4 measuring avoidance). The items assess symptoms over the past 7 days on a 4-point scale (0=not at all, 1= rarely, 3=sometimes, 5=often). Intrusion sub-scale is the sum of items 1,3,6 and 7. Avoidance sub-scale is the sum of items 2,4,5 and 8. Scores can range from 0-40 with greater scores indicating greater symptom severity. A total score of 17 or higher indicates PTSD.

  10-month follow up

• PTSD symptoms: Child Post Traumatic Stress Scale (CPSS-5; Foa et al. 2001)

  A self-report questionnaire with 27 items relating to the past one month. The first 20 items evaluate the frequency and severity of PTSD symptoms. Items are rated on a 5-point scale (0= not at all, 1 = \<once a week, 2= 2-3 times per week, 3 = 4-5 times a week, 4 = 6 or more times per week). The final 7 items evaluate functional impairment an are scored 1 ('Yes') or 0 ('No') with scores ranging from 0-7, greater scores indicate greater impairment. From the first part of the CPSS scores can range between 0-80 with higher scores indicating greater symptom severity. A score of 31 or higher indicates PTSD.

  10-month follow up

• PTSD symptoms: Child Post Traumatic Cognitions Inventory (CPTCI, McKinnon et al 2016)

  A self-report questionnaire with 10 items. The CPTCI measures PTSD symptoms since the traumatic event occurred, on a scale of 1-4 (1= don't agree at all, 2 = don't agree a bit, 3 = agree a bit, 4 = agree a lot). Scores range from 0-40 with greater scores indicating greater symptom severity. A total score of 16 or above is considered clinically significant.

  10-month follow up

• PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al., 2005)

  A self-report questionnaire with 8 items (4 measuring intrusions, 4 measuring avoidance). The items assess symptoms over the past 7 days on a 4-point scale (0=not at all, 1= rarely, 3=sometimes, 5=often). Intrusion sub-scale is the sum of items 1,3,6 and 7. Avoidance sub-scale is the sum of items 2,4,5 and 8. Scores can range from 0-40 with greater scores indicating greater symptom severity. A total score of 17 or higher indicates PTSD.

  Week 1

• PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al., 2005)

  A self-report questionnaire with 8 items (4 measuring intrusions, 4 measuring avoidance). The items assess symptoms over the past 7 days on a 4-point scale (0=not at all, 1= rarely, 3=sometimes, 5=often). Intrusion sub-scale is the sum of items 1,3,6 and 7. Avoidance sub-scale is the sum of items 2,4,5 and 8. Scores can range from 0-40 with greater scores indicating greater symptom severity. A total score of 17 or higher indicates PTSD.

  Week 2

• PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al., 2005)

  A self-report questionnaire with 8 items (4 measuring intrusions, 4 measuring avoidance). The items assess symptoms over the past 7 days on a 4-point scale (0=not at all, 1= rarely, 3=sometimes, 5=often). Intrusion sub-scale is the sum of items 1,3,6 and 7. Avoidance sub-scale is the sum of items 2,4,5 and 8. Scores can range from 0-40 with greater scores indicating greater symptom severity. A total score of 17 or higher indicates PTSD.

  Week 3

• PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al., 2005)

  A self-report questionnaire with 8 items (4 measuring intrusions, 4 measuring avoidance). The items assess symptoms over the past 7 days on a 4-point scale (0=not at all, 1= rarely, 3=sometimes, 5=often). Intrusion sub-scale is the sum of items 1,3,6 and 7. Avoidance sub-scale is the sum of items 2,4,5 and 8. Scores can range from 0-40 with greater scores indicating greater symptom severity. A total score of 17 or higher indicates PTSD.

  Week 4

• PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al., 2005)

  A self-report questionnaire with 8 items (4 measuring intrusions, 4 measuring avoidance). The items assess symptoms over the past 7 days on a 4-point scale (0=not at all, 1= rarely, 3=sometimes, 5=often). Intrusion sub-scale is the sum of items 1,3,6 and 7. Avoidance sub-scale is the sum of items 2,4,5 and 8. Scores can range from 0-40 with greater scores indicating greater symptom severity. A total score of 17 or higher indicates PTSD.

  Week 5

• PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al., 2005)

  A self-report questionnaire with 8 items (4 measuring intrusions, 4 measuring avoidance). The items assess symptoms over the past 7 days on a 4-point scale (0=not at all, 1= rarely, 3=sometimes, 5=often). Intrusion sub-scale is the sum of items 1,3,6 and 7. Avoidance sub-scale is the sum of items 2,4,5 and 8. Scores can range from 0-40 with greater scores indicating greater symptom severity. A total score of 17 or higher indicates PTSD.

  Week 6

• PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al., 2005)

  A self-report questionnaire with 8 items (4 measuring intrusions, 4 measuring avoidance). The items assess symptoms over the past 7 days on a 4-point scale (0=not at all, 1= rarely, 3=sometimes, 5=often). Intrusion sub-scale is the sum of items 1,3,6 and 7. Avoidance sub-scale is the sum of items 2,4,5 and 8. Scores can range from 0-40 with greater scores indicating greater symptom severity. A total score of 17 or higher indicates PTSD.

  Week 7

• PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al., 2005)

  A self-report questionnaire with 8 items (4 measuring intrusions, 4 measuring avoidance). The items assess symptoms over the past 7 days on a 4-point scale (0=not at all, 1= rarely, 3=sometimes, 5=often). Intrusion sub-scale is the sum of items 1,3,6 and 7. Avoidance sub-scale is the sum of items 2,4,5 and 8. Scores can range from 0-40 with greater scores indicating greater symptom severity. A total score of 17 or higher indicates PTSD.

  Week 8

• PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al., 2005)

  A self-report questionnaire with 8 items (4 measuring intrusions, 4 measuring avoidance). The items assess symptoms over the past 7 days on a 4-point scale (0=not at all, 1= rarely, 3=sometimes, 5=often). Intrusion sub-scale is the sum of items 1,3,6 and 7. Avoidance sub-scale is the sum of items 2,4,5 and 8. Scores can range from 0-40 with greater scores indicating greater symptom severity. A total score of 17 or higher indicates PTSD.

  Week 9

• PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al., 2005)

  A self-report questionnaire with 8 items (4 measuring intrusions, 4 measuring avoidance). The items assess symptoms over the past 7 days on a 4-point scale (0=not at all, 1= rarely, 3=sometimes, 5=often). Intrusion sub-scale is the sum of items 1,3,6 and 7. Avoidance sub-scale is the sum of items 2,4,5 and 8. Scores can range from 0-40 with greater scores indicating greater symptom severity. A total score of 17 or higher indicates PTSD.

  Week 10

• PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al., 2005)

  A self-report questionnaire with 8 items (4 measuring intrusions, 4 measuring avoidance). The items assess symptoms over the past 7 days on a 4-point scale (0=not at all, 1= rarely, 3=sometimes, 5=often). Intrusion sub-scale is the sum of items 1,3,6 and 7. Avoidance sub-scale is the sum of items 2,4,5 and 8. Scores can range from 0-40 with greater scores indicating greater symptom severity. A total score of 17 or higher indicates PTSD.

  Week 11

• PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al., 2005)

  A self-report questionnaire with 8 items (4 measuring intrusions, 4 measuring avoidance). The items assess symptoms over the past 7 days on a 4-point scale (0=not at all, 1= rarely, 3=sometimes, 5=often). Intrusion sub-scale is the sum of items 1,3,6 and 7. Avoidance sub-scale is the sum of items 2,4,5 and 8. Scores can range from 0-40 with greater scores indicating greater symptom severity. A total score of 17 or higher indicates PTSD.

  Week 12

• Acceptability of iCT: Qualitative interviews

  Qualitative interviews with N=6 young people, their carers, and their therapists.

  Post-Treatment (at 4 months)

• Acceptability of iCT: Likert Scales

  Young people will be asked to complete ratings of acceptability on a scale from 0 to 100.

  Post-Treatment (at 4 months)

• Adherence to online intervention: time spent logged in to programme

  Time spent logged on to online programme in seconds:minutes:hours according to the device used (smartphone, tablet or computer).

  up to week 12

• Adherence to online intervention: number of times logged on

  The number of times a participant logs on to the online programme

  up to week 12

• Adherence to online intervention: number of modules completed

  The number of online modules the young person completes during the 12 week intervention

  up to week 12

• Adherence to online intervention: number of phone calls between therapist and young person

  The number of times the participant spoke to the therapist on the phone

  up to week 12

• Adherence to online intervention: time spent on phone calls with the therapist

  Time spent on phone calls with the therapist in seconds:minutes:hours

  up to week 12

• Adherence to online intervention: number of messages exchanged with the therapist

  Number of messages exchanged between the patient and the therapist

  up to week 12

Secondary Outcomes (9)

• Revised Children's Anxiety and Depression Scale (RCADS-C; Chorpita & Ebesutani 2014): Measure of young person's anxiety and depression symptoms

  Baseline

• Revised Children's Anxiety and Depression Scale (RCADS-P Chorpita & Ebesutani 2014): Measure of young person's anxiety and depression symptoms

  Baseline

• Revised Children's Anxiety and Depression Scale (RCADS-C; Chorpita & Ebesutani 2014): Measure of young person's anxiety and depression symptoms

  post-treatment (at 4 months)

• Revised Children's Anxiety and Depression Scale (RCADS-P Chorpita & Ebesutani 2014): Measure of young person's anxiety and depression symptoms

  post-treatment (at 4 months)

• Revised Children's Anxiety and Depression Scale (RCADS-C; Chorpita & Ebesutani 2014): Measure of young person's anxiety and depression symptoms

  at 10-month follow up

Study Arms (1)

internet-Cognitive Therapy for PTSD

EXPERIMENTAL

This is a single-arm study. All participants will receive the same therapist supported, internet-delivered intervention.

Behavioral: internet-delivered Cognitive Therapy for PTSD (iCT)

Interventions

internet-delivered Cognitive Therapy for PTSD (iCT) BEHAVIORAL

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.

internet-Cognitive Therapy for PTSD

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Participant is aged 12-17 years old
• 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.

You may not qualify if:

• Brain damage assessed by clinical interview with parents / carers
• 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.

Sponsors & Collaborators

• King's College London: lead
• Medical Research Council: collaborator
• South London and Maudsley NHS Foundation Trust: collaborator

Study Sites (2)

King's College London/ South London and Maudsley NHS Foundation Trust

London, SE5 8AF, United Kingdom

RECRUITING

University of East Anglia/ Norfolk and Suffolk NHS Foundation Trust

Norwich, NR4 7TJ, United Kingdom

NOT YET RECRUITING

Related Publications (5)

• 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.

  PMID: 11501254 BACKGROUND

• 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.

  PMID: 11699809 BACKGROUND

• 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.

  PMID: 27191657 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

Related Links

• 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.

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Wounds and Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Patrick Smith, PhD

  King's College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick A Smith, PhD

CONTACT

02078480506; patrick.smith@kcl.ac.uk

Monica Gupta, MSc

CONTACT

02078480580; monica.gupta@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Uncontrolled case series

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: May 2, 2019
• Study Start: April 1, 2019
• Primary Completion: September 30, 2019
• Study Completion: December 31, 2019
• Last Updated: August 13, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)