Guided Internet-based Trauma-focused CBT Programme for Post-traumatic Stress Disorder 'Spring'

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVilnius University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Regularly seeing a therapist or counsellor for mental health issues

Change in psychotropic medication in the last month

CPTSD diagnosis

Psychosis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Internet-based guided programme Spring

    Behavioral

    Spring is an online guided self-help programme based on the principles of trauma-focused cognitive behavioral therapy and consists of 8 steps designed for delivery over 8 weeks. The steps cover 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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Immediate treatment groupExperimental treatment 1 intervention
Group B: Delayed treatment control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
baseline; 10 weeks after randomization

Secondary outcomes

1

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.

Time frame
baseline; 22 weeks after randomization
2

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.

Time frame
baseline; 10 weeks after randomization; 22 weeks after randomization
3

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.

Time frame
baseline; 10 weeks after randomization; 22 weeks after randomization; 32 weeks after randomization (delayed treatment group only)
4

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.

Time frame
baseline; 10 weeks after randomization; 22 weeks after randomization; 32 weeks after randomization (delayed treatment group only)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vilnius University

Lead sponsor

Cardiff University

Collaborator

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