Posttraumatic Stress DisorderSPRING-LTNCT06475716
Guided Internet-based Trauma-focused CBT Programme for Post-traumatic Stress Disorder 'Spring'
A study testing Internet-based guided programme Spring in people with Posttraumatic Stress Disorder, run by Vilnius University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Internet-based guided programme Spring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 10 Sep 2024to 20 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy of a Guided Internet-based Trauma-focused CBT Intervention 'Spring' for ICD-11 Posttraumatic Stress Disorder Symptoms: A Randomized Controlled 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.
Read the 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.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Internet-based guided programme Spring
- Keywords
- trauma, posttraumatic stress, treatment, cognitive behavior therapy, internet-based intervention
- Medical subject headings
- Stress Disorders, Post-Traumatic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based guided programme SpringBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate treatment group | Experimental | 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. Receives: Behavioral: Internet-based guided programme Spring |
| Delayed treatment control group | Active comparator | 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. Receives: Behavioral: Internet-based guided programme Spring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline; 10 weeks after randomization
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (before start using the intervention programme)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start10 Sep 2024 (estimated)
- Primary completion20 Dec 2025 (estimated)
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vilnius University
- Sponsor type
- University, hospital or other
- Collaborators
- Cardiff University
- Responsible party
- Sponsor
- Investigators
- Odeta Gelezelyte, Dr., Principal investigator, Vilnius University, Centre for Psychotraumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06475716
- Sponsor's protocol ID
- S-MIP-23-14
- Acronym
- SPRING-LT
- Status last verified
- Jun 2024
- First submitted
- 17 Jun 2024
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized datasets used during the study will be available from the corresponding author upon reasonable request.
Publications
Gelezelyte O, Guogaite G, Nomeikaite A, Bisson JI, Lewis C, Kazlauskas E. Efficacy of an internet-based guided trauma-focused intervention in reducing ICD-11 posttraumatic stress disorder symptoms: study protocol of a randomized controlled trial. BMC Psychiatry. 2024 Sep 30;24(1):645. doi: 10.1186/s12888-024-06097-0.
PubMed 39350097
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Guided Internet-based Trauma-focused CBT Intervention 'Spring' for ICD-11 Posttraumatic Stress Disorder Symptoms: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06475716
- Acronym / sponsor ID
- SPRING-LT / S-MIP-23-14
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- trauma, posttraumatic stress, treatment, cognitive behavior therapy, internet-based intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Vilnius UniversityUniversity, hospital or other
- Collaborators
- Cardiff University
- Study start
- 10 Sep 2024 (estimated)
- Primary completion
- 20 Dec 2025 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 26 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Immediate treatment group | Experimental | Behavioral: Internet-based guided programme SpringThe 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. |
| Delayed treatment control group | Active comparator | Behavioral: Internet-based guided programme SpringThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- Regularly seeing a therapist or counsellor for mental health issues
- Change in psychotropic medication in the last month
- CPTSD diagnosis
- Psychosis
- Severe suicide risk
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-based guided programme SpringSpring 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. | Behavioural | Delayed treatment control group, Immediate treatment group |
Primary outcome
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.
12 secondary outcomes
Change in International Trauma Interview (ITI) PTSD score at a three-month follow-up
Time frame: baseline; 22 weeks after randomization
Change in International Trauma Interview (ITI) DSO score
Time frame: baseline; 10 weeks after randomization; 22 weeks after randomization
Change in International Trauma Questionnaire (ITQ) score
Time frame: baseline; 10 weeks after randomization; 22 weeks after randomization; 32 weeks after randomization (delayed treatment group only)
Change in International Depression Questionnaire (IDQ) score
Time frame: baseline; 10 weeks after randomization; 22 weeks after randomization; 32 weeks after randomization (delayed treatment group only)
Change in International Anxiety Questionnaire (IAQ) score
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: baseline; 10 weeks after randomization; 22 weeks after randomization; 32 weeks after randomization (delayed treatment group only)
Patient satisfaction questionnaire (ZUF-8)
Time frame: 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)
Time frame: 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)
Time frame: Baseline (before start using the intervention programme)
The Treatment Expectation Questionnaire (TEX-Q)
Time frame: Baseline (before start using the intervention programme)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Derived from this study: PubMed 39350097Gelezelyte O, Guogaite G, Nomeikaite A, Bisson JI, Lewis C, Kazlauskas E. Efficacy of an internet-based guided trauma-focused intervention in reducing ICD-11 posttraumatic stress disorder symptoms: study protocol of a randomized controlled trial. BMC Psychiatry. 2024 Sep 30;24(1):645. doi: 10.1186/s12888-024-06097-0.
- Individual participant dataSharing planned: Yes. Anonymized datasets used during the study will be available from the corresponding author upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Odeta Gelezelyte, Dr. principal investigator
Vilnius University, Centre for Psychotraumatology
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based guided programme Spring in people with Posttraumatic Stress Disorder, run by Vilnius University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Odeta Gelezelyte, Dr. (+37052686952, odeta.gelezelyte@fsf.vu.lt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in International Trauma Interview (ITI) PTSD score post-treatment (time frame: baseline; 10 weeks after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06475716, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.