Efficacy of a Guided Internet-based Trauma-focused CBT Intervention 'Spring' for ICD-11 Posttraumatic Stress Disorder Symptoms: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Vilnius University
- Enrollment
- 50
- Primary Endpoint
- Change in International Trauma Interview (ITI) PTSD score post-treatment
Study Overview
Brief Summary
The main aim of the study is to evaluate the efficacy of the Lithuanian version of the internet-based guided self-help programme (Spring) in reducing ICD-11 PTSD symptoms.
Detailed Description
Spring is an online guided self-help programme for the reduction of posttraumatic stress disorder symptoms. It is based on the principles of trauma-focused cognitive behavioral therapy and consists of 8 steps covering psychoeducation, grounding techniques, management of anxiety, behavioral activation, imaginal exposure, cognitive restructuring, in vivo exposure, and prevention of relapse. The user of the programme also receives up to 3 hours of therapist guidance. Originally Spring was developed by the research team at Cardiff University. In the current study, the most recent second version of the Spring programme adapted to the Lithuanian population will be used. The main aim of the study is to evaluate the efficacy of the Lithuanian version of the Spring programme in reducing ICD-11 posttraumatic stress disorder symptoms.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Semi-structured interviews will be administered by researchers blind to randomization allocation at baseline, 10 and 22 weeks after randomization. Self-report data will be collected via a secure online platform, so it will help avoid ascertainment bias in the measurement of outcomes.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged 18 years or over
- •Ability to read and write fluently in Lithuanian
- •Have regular access to a device with an internet connection to use the programme
- •Provide informed consent for participation
- •Experience PTSD symptoms followed by a non-prolonged and non-repetitive traumatic experience as measured by the ITI
Exclusion Criteria
- •Regularly seeing a therapist or counsellor for mental health issues
- •Change in psychotropic medication in the last month
- •CPTSD diagnosis
- •Psychosis
- •Severe suicide risk
- •Substance dependence
- •Experiencing ongoing threat
Arms & Interventions
Immediate treatment group
The immediate treatment group will receive the intervention immediately after randomization. The intervention includes using an online guided self-help programme Spring that is based on the principles of trauma-focused cognitive behavioral therapy and consists of 8 steps. The user of the programme also receives up to 3 hours of guidance by a trained therapist.
Intervention: Internet-based guided programme Spring (Behavioral)
Delayed treatment control group
The delayed treatment group will receive the same intervention as the immediate treatment group, but 24 weeks after randomization. The intervention includes using an online guided self-help programme Spring that is based on the principles of trauma-focused cognitive behavioral therapy and consists of 8 steps. The user of the programme also receives up to 3 hours of guidance by a trained therapist.
Intervention: Internet-based guided programme Spring (Behavioral)
Outcomes
Primary Outcomes
Change in International Trauma Interview (ITI) PTSD score post-treatment
Time Frame: baseline; 10 weeks after randomization
The ITI is a semi-structured clinical interview for the assessment of symptoms of ICD-11 posttraumatic stress disorder. The total ITI score measuring symptoms of PTSD may range from 0 to 24. Higher scores indicate greater symptom severity.
Secondary Outcomes
- Change in Trauma Related Shame Inventory - Short Form (TRSI-SF)(baseline; 10 weeks after randomization; 22 weeks after randomization; 32 weeks after randomization (delayed treatment group only))
- Readiness for Therapy Questionnaire (RTQ)(Baseline (before start using the intervention programme))
- Change in Brief Version of the Posttraumatic Cognitions Inventory (PTCI-9)(baseline; 10 weeks after randomization; 22 weeks after randomization; 32 weeks after randomization (delayed treatment group only))
- Change in International Anxiety Questionnaire (IAQ) score(baseline; 10 weeks after randomization; 22 weeks after randomization; 32 weeks after randomization (delayed treatment group only))
- Working Alliance Inventory for guided Internet Interventions (WAI-I)(5 and 10 weeks after randomization (immediate treatment group only); 27 and 32 weeks after randomization (delayed treatment group only))
- Change in International Trauma Interview (ITI) DSO score(baseline; 10 weeks after randomization; 22 weeks after randomization)
- Change in World Health Organization Well-Being Index (WHO-5) score(baseline; 10 weeks after randomization; 22 weeks after randomization; 32 weeks after randomization (delayed treatment group only))
- Change in International Trauma Interview (ITI) PTSD score at a three-month follow-up(baseline; 22 weeks after randomization)
- Change in International Trauma Questionnaire (ITQ) score(baseline; 10 weeks after randomization; 22 weeks after randomization; 32 weeks after randomization (delayed treatment group only))
- Change in International Depression Questionnaire (IDQ) score(baseline; 10 weeks after randomization; 22 weeks after randomization; 32 weeks after randomization (delayed treatment group only))
- Patient satisfaction questionnaire (ZUF-8)(10 weeks after randomization (immediate treatment group only); 32 weeks after randomization (delayed treatment group only))
- The Treatment Expectation Questionnaire (TEX-Q)(Baseline (before start using the intervention programme))