Skip to content

A study of trauma-focused online guided self help versus trauma-focused cognitive behavioural therapy for post-traumatic stress disorder

Pragmatic randomised controlled trial of a trauma-focused guided self help programme versus individual trauma-focused cognitive behavioural therapy for post traumatic stress disorder

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13697710
Enrollment
192
Registered
2016-12-21
Start date
2017-08-29
Completion date
Unknown
Last updated
2023-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-traumatic stress disorder following a single traumatic event Mental and Behavioural Disorders Post-traumatic stress disorder following a single traumatic event

Interventions

Participants are randomised to one of two groups. Intervention group: Participants receive Online Guided Self Help based on Trauma Focused Cognitive Behavioural Therapy (8 weeks)

Sponsors

Cardiff University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18 years or over 2. Screen positive for PTSD on the Traumatic Screening Questionnaire (TSQ) following a single traumatic event experienced at any age 3. Regular access to the internet in order to complete the modules and homework required by the Guided Self Help (GSH) programme 4. Provide informed consent 5. After a two week monitoring period, continue to meet Clinician Administered PTSD Scale (CAPS-5) criteria for mild to moderate PTSD (less than 50 on the CAPS-5) 6. PTSD is the primary diagnosis

Exclusion criteria

Exclusion criteria: 1. Inability to read and write fluently in English 2. Previous completion of a course of Trauma-focused Cognitive Behavioural Therapy (TFCBT) for PTSD 3. Currently engaged in a psychological therapy 4. Change in psychotropic medication in last four weeks 5. Psychosis 6. Substance dependence 7. Active suicide risk

Design outcomes

Primary

MeasureTime frame
Change in PTSD symtoms Clinician Administered PTSD Scale for DSM5 (CAPS-5) at 16 weeks.

Secondary

MeasureTime frame
1. PTSD symptoms, as measured using the Clinician-Administered PTSD Scale (CAPS-5) at 52 weeks post randomisation and Impact of Events Scale - Revised (IES-R) at 16 weeks and 52 weeks post-randomisation. IES-R is also completed at each therapy session. 2. Quality of life is measured using the EQ-5D-5L questionnaire at baseline, 16 and 52 weeks 3. Functional impairment is measured using the Work and Social Adjustment Scale (WSAS) at baseline, 16 and 52 weeks 4. Depression is measured using the Patient Health Questionnaire (PHQ-9) at baseline, 16 and 52 weeks 5. Anxiety symptoms are measured using the Generalized Anxiety Disorder 7-item (GAD-7) scale at baseline, 16 and 52 weeks 6. Alcohol use is measured using the AUDIT-O questionnaire at baseline, 16 and 52 weeks 7. Social Support is measured using the Multidimensional Scale of Perceived Social Support (MSPSS) at baseline, 16 and 52 weeks 8. Insomnia is measured using the Insomnia Severity Index (ISI) at baseline, 16 and 52 weeks 9. Self-efficacy is measured using the General Self-Efficacy Scale (GSES) at baseline, 16 and 52 weeks 10. Cognition is measured using the Posttraumatic Cognitions Inventory (PTCI) at baseline, 16 and 52 weeks 11. Health care usage using an adapted version of the CSSRI-EU at baseline, 16 and 52 weeks

Countries

United Kingdom, Wales

Contacts

Public ContactPaula Foscarini-Craggs
rapid@cardiff.ac.uk+44 (0)2920 687 522

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 24, 2026