Guided Internet-based Trauma-focused CBT Programme for Post-traumatic Stress Disorder 'Spring' (SPRING-LT)

June 25, 2024 updated by: Vilnius University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Immediate treatment group
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.
Behavioral: Internet-based guided programme Spring
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.
Active Comparator: Delayed treatment control group
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.
Behavioral: Internet-based guided programme Spring
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
baseline; 10 weeks after randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in International Trauma Interview (ITI) PTSD score at a three-month follow-up
Time Frame: 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.
baseline; 22 weeks after randomization
Change in International Trauma Interview (ITI) DSO score
Time Frame: 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.
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)
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
Time Frame: 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.
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)
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
Time Frame: 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.
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)
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)
Time Frame: 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.
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)
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)
Time Frame: 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.
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)
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)
Time Frame: 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.
Baseline (before start using the intervention programme)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vilnius University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cardiff University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Odeta Gelezelyte, Dr., Vilnius University, Centre for Psychotraumatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 10, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 17, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 26, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • S-MIP-23-14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized datasets used during the study will be available from the corresponding author upon reasonable request.

IPD Sharing Time Frame

After the main results of the study are published.

IPD Sharing Access Criteria

Anonymized datasets used during the study will be available from the corresponding author upon reasonable request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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