Guided Internet-based Trauma-focused CBT Programme for Post-traumatic Stress Disorder 'Spring'
- Conditions
- Posttraumatic Stress Disorder
- Interventions
- Behavioral: Internet-based guided programme Spring
- Registration Number
- NCT06475716
- Lead Sponsor
- Vilnius University
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Delayed treatment control group Internet-based guided programme Spring 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. Immediate treatment group Internet-based guided programme Spring 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.
- Primary Outcome Measures
Name Time Method Change in International Trauma Interview (ITI) PTSD score post-treatment 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 Outcome Measures
Name Time Method 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) TRSI-SF is a self-report scale measuring trauma-related shame. The final score ranges from 0 to 30. Higher scores indicate higher levels of shame.
Readiness for Therapy Questionnaire (RTQ) Baseline (before start using the intervention programme) RTQ is a self-report measure of clients' readiness for change. The final score ranges from 0 to 24. Higher scores indicate greater readiness for therapy.
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) PTCI-9 is a self-report measure assessing posttraumatic appraisals. The final score ranges from 9 to 63. Higher scale scores indicate stronger endorsement of negative cognitions.
Change in International Anxiety Questionnaire (IAQ) score baseline; 10 weeks after randomization; 22 weeks after randomization; 32 weeks after randomization (delayed treatment group only) The IAQ is a self-report questionnaire for the assessment of ICD-11 anxiety symptoms. Possible range of scores varies from 0 to 32. Higher scores indicate greater symptom severity.
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) WAI-I is a self-report instrument to assess the working alliance in the context of guided Internet interventions. The overall WAI-I score ranges from 12 to 60. Higher scores reflect stronger working alliance.
Change in International Trauma Interview (ITI) DSO score baseline; 10 weeks after randomization; 22 weeks after randomization The ITI is a semi-structured clinical interview for the assessment of symptoms of ICD-11 posttraumatic stress disorder and disturbances is self organization (DSO). The total ITI score measuring DSO symptoms may range from 0 to 24. Higher scores indicate greater symptom severity.
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) The WHO-5 is a five-item self-report scale that assesses subjective psychological well-being. The range of the final WHO-5 index score ranges from 0 to 100, with higher scores indicating better well-being.
Change in International Trauma Interview (ITI) PTSD score at a three-month follow-up baseline; 22 weeks after randomization The ITI is a semi-structured clinical interview for the assessment of symptoms of ICD-11 posttraumatic stress disorder and disturbances is self organization (DSO). The total ITI score measuring DSO symptoms may range from 0 to 24. Higher scores indicate greater symptom severity.
Change in International Trauma Questionnaire (ITQ) score baseline; 10 weeks after randomization; 22 weeks after randomization; 32 weeks after randomization (delayed treatment group only) The ITQ is a self-report questionnaire for the assessment of symptoms of ICD-11 posttraumatic stress disorder and complex posttraumatic stress disorder. The overall ITQ score ranges from 0 to 24. Higher scores indicate greater symptom severity.
Change in International Depression Questionnaire (IDQ) score baseline; 10 weeks after randomization; 22 weeks after randomization; 32 weeks after randomization (delayed treatment group only) The IDQ is a self-report questionnaire for the assessment of ICD-11 depression symptoms. Possible range of scores varies from 0 to 36. Higher scores indicate greater symptom severity.
Patient satisfaction questionnaire (ZUF-8) 10 weeks after randomization (immediate treatment group only); 32 weeks after randomization (delayed treatment group only) ZUF-8 is a self-report instrument for measuring patient satisfaction with the treatment/service received. The final score ranges from 8 to 32. Higher scores indicate stronger satisfaction with treatment.
The Treatment Expectation Questionnaire (TEX-Q) Baseline (before start using the intervention programme) TEX-Q is a self-report assessment of clients' treatment expectations. The TEX-Q consists of 6 subscales: treatment benefit, positive impact, adverse events, negative impact, process, behavior control. Each item of the TEX-Q subscales is measured on a scale from 0 to 10. The mean score can range from 0 to 10. The overall score of TEX-Q is determined by calculating the mean with a reversal of the harm expectation subscales; higher values indicate more positive treatment expectations.