Online PTSD Treatment for Young People and Carers - Case Series
- Conditions
- Post Traumatic Stress Disorder
- Interventions
- Behavioral: internet-delivered Cognitive Therapy for PTSD (iCT)
- Registration Number
- NCT03935035
- Lead Sponsor
- King's College London
- 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.
- Detailed Description
PTSD is prevalent among young people, and is distressing and impairing. Face-to-face trauma-focussed CBT (TFCBT) is an effective short-term therapy for PTSD in young people. The researchers previously developed Cognitive Therapy for PTSD (CT-PTSD) in children and young people, and have shown in 2 published RCTs that it is efficacious when delivered face-to-face. However, most young people with PTSD do not receive effective, evidence-based treatments. This is in part due to under-capacity in NHS CAMHS, and in part due to the burden and inconvenience to young people in attending face-to-face appointments in a clinic. In this project the researchers propose to make CT for PTSD widely available to young people by delivering the therapy via the internet, with therapist support. The rationale for this approach is that (1) young people will engage with internet-delivered therapy, and online therapies for other disorders such as depression have demonstrated efficacy in clinical trials; (2) effective online therapies for adults with PTSD have been developed and evaluated; (3) no online treatments for young people with PTSD have yet been developed.
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 6
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description internet-Cognitive Therapy for PTSD internet-delivered Cognitive Therapy for PTSD (iCT) This is a single-arm study. All participants will receive the same therapist supported, internet-delivered intervention.
- Primary Outcome Measures
Name Time Method PTSD symptoms: Child Post Traumatic Stress Scale (CPSS-5; Foa et al. 2001) 10-month follow up 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.
Adherence to online intervention: number of messages exchanged with the therapist up to week 12 Number of messages exchanged between the patient and the therapist
PTSD symptoms: Child Post Traumatic Cognitions Inventory (CPTCI, McKinnon et al 2016) 10-month follow up 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.
Adherence to online intervention: time spent logged in to programme up to week 12 Time spent logged on to online programme in seconds:minutes:hours according to the device used (smartphone, tablet or computer).
Adherence to online intervention: number of times logged on up to week 12 The number of times a participant logs on to the online programme
PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al., 2005) Week 12 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.
Adherence to online intervention: time spent on phone calls with the therapist up to week 12 Time spent on phone calls with the therapist in seconds:minutes:hours
PTSD symptom scale: Clinician Administered PTSD Scale for Children and Adolescents (CAPS-CA-5, Pynoos et al., 2015) Baseline 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.
PTSD symptom scale: using the Clinician Administered PTSD Scale for Children and Adolescents (CAPS-CA-5, Pynoos et al., 2015) post-intervention (at 4 months) 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.
Acceptability of iCT: Qualitative interviews Post-Treatment (at 4 months) Qualitative interviews with N=6 young people, their carers, and their therapists.
Acceptability of iCT: Likert Scales Post-Treatment (at 4 months) Young people will be asked to complete ratings of acceptability on a scale from 0 to 100.
Adherence to online intervention: number of modules completed up to week 12 The number of online modules the young person completes during the 12 week intervention
PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al 2005) 10-month follow up 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.
Adherence to online intervention: number of phone calls between therapist and young person up to week 12 The number of times the participant spoke to the therapist on the phone
- Secondary Outcome Measures
Name Time Method Revised Children's Anxiety and Depression Scale (RCADS-P Chorpita & Ebesutani 2014): Measure of young person's anxiety and depression symptoms at 10-month follow up A 47-item parent rated questionnaire. Items are rated on a 4-point scale (0= never, 1 = sometimes, 2= often, 3 = always). The RCADS-P can be scored using spreadsheets available from the developer. The young person's school year must be entered (enter the year number according to the US grade system) and a 't-score' is calculated. A t-score of 70 or more is considered clinically significant. The greater the t-score the greater the symptoms.
Strength & Difficulties Questionnaire (SDQ-P; Goodman, 2001): Measure of young person's emotional and behavioural difficulties at 10-month follow up Parent rated questionnaire with 25 items. Items are rated on a 3-point scale (0=not true, 1=somewhat true, 2= certainly true). There are 5 sub-scales each with scores ranging from 0-10. The total difficulties score is calculated by summing 4 of the sub-scales to give a score between 0-40. A total difficulties score of 17 or above is considered clinically significant. The greater the total score, the greater the difficulties experienced.
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 A 47-item self-report questionnaire. Items are rated on a 4-point scale (0= never, 1 = sometimes, 2= often, 3 = always). The RCADS can be scored using spreadsheets available from the developer. The young person's school year must be entered (enter the year number according to the US grade system) and a 't-score' is calculated. A t-score of 70 or more is considered clinically significant. The greater the t-score the greater the symptoms.
Trial Locations
- Locations (2)
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