Clinical trial NCT06475716: Guided Internet-based Trauma-focused CBT Programme for Post-traumatic Stress Disorder 'Spring'
Official title: Efficacy of a Guided Internet-based Trauma-focused CBT Intervention 'Spring' for ICD-11 Posttraumatic Stress Disorder Symptoms: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: trauma
posttraumatic stress
treatment
cognitive behavior therapy
internet-based intervention
Lead sponsor: Vilnius University
Sponsor class: OTHER
Collaborators: name: Cardiff University
First posted: 2024-06-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to the immediate treatment group or delayed treatment control group. The immediate treatment group will receive the intervention immediately after randomization. The delayed treatment group will receive the intervention 22 weeks after randomization.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

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