Guided Internet-based Trauma-focused CBT Programme for Post-traumatic Stress Disorder 'Spring'
NCT Number: NCT06475716
Acronym: SPRING-LT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Posttraumatic Stress Disorder
Interventions: BEHAVIORAL: Internet-based guided programme Spring
Sponsor: Vilnius University
Collaborators: Cardiff University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-10
Completion Date: 2025-12-20

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.

Primary Outcome Measures: Change in International Trauma Interview (ITI) PTSD score post-treatment, 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., baseline; 10 weeks after randomization
Secondary Outcome Measures: Change in International Trauma Interview (ITI) PTSD score at a three-month follow-up, 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., baseline; 22 weeks after randomization|Change in International Trauma Interview (ITI) DSO score, 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., baseline; 10 weeks after randomization; 22 weeks after randomization|Change in International Trauma Questionnaire (ITQ) score, 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., baseline; 10 weeks after randomization; 22 weeks after randomization; 32 weeks after randomization (delayed treatment group only)|Change in International Depression Questionnaire (IDQ) score, 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., baseline; 10 weeks after randomization; 22 weeks after randomization; 32 weeks after randomization (delayed treatment group only)|Change in International Anxiety Questionnaire (IAQ) score, 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., baseline; 10 weeks after randomization; 22 weeks after randomization; 32 weeks after randomization (delayed treatment group only)|Change in World Health Organization Well-Being Index (WHO-5) score, 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., baseline; 10 weeks after randomization; 22 weeks after randomization; 32 weeks after randomization (delayed treatment group only)|Change in Brief Version of the Posttraumatic Cognitions Inventory (PTCI-9), 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., baseline; 10 weeks after randomization; 22 weeks after randomization; 32 weeks after randomization (delayed treatment group only)|Change in Trauma Related Shame Inventory - Short Form (TRSI-SF), 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., baseline; 10 weeks after randomization; 22 weeks after randomization; 32 weeks after randomization (delayed treatment group only)|Patient satisfaction questionnaire (ZUF-8), 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., 10 weeks after randomization (immediate treatment group only); 32 weeks after randomization (delayed treatment group only)|Working Alliance Inventory for guided Internet Interventions (WAI-I), 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., 5 and 10 weeks after randomization (immediate treatment group only); 27 and 32 weeks after randomization (delayed treatment group only)|Readiness for Therapy Questionnaire (RTQ), 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., Baseline (before start using the intervention programme)|The Treatment Expectation Questionnaire (TEX-Q), 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., Baseline (before start using the intervention programme)