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

NCT06475716 | Not Yet Recruiting

• 1 other identifier: S-MIP-23-14
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Posttraumatic Stress Disorder

Keywords

trauma; posttraumatic stress; treatment; cognitive behavior therapy; internet-based intervention

Outcome Measures

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.

  baseline; 10 weeks after randomization

Secondary Outcomes (12)

• Change in International Trauma Interview (ITI) PTSD score at a three-month follow-up

  baseline; 22 weeks after randomization

• Change in International Trauma Interview (ITI) DSO score

  baseline; 10 weeks after randomization; 22 weeks after randomization

• Change in International Trauma Questionnaire (ITQ) score

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

• Change in International Depression Questionnaire (IDQ) score

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

• Change in International Anxiety Questionnaire (IAQ) score

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

Study Arms (2)

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.

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.

Behavioral: Internet-based guided programme Spring

Interventions

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.

Delayed treatment control group; Immediate treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vilnius University: lead
• Cardiff University: collaborator

Related Publications (1)

• 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.

  PMID: 39350097 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Wounds and Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Odeta Gelezelyte, Dr.

  Vilnius University, Centre for Psychotraumatology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Odeta Gelezelyte, Dr.

CONTACT

+37052686952; odeta.gelezelyte@fsf.vu.lt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Semi-structured interviews will be administered by researchers blind to randomization allocation at baseline, 10 and 22 weeks after randomization. Self-report data will be collected via a secure online platform, so it will help avoid ascertainment bias in the measurement of outcomes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 26, 2024
• Study Start: September 10, 2024
• Primary Completion: December 20, 2025
• Study Completion: December 20, 2025
• Last Updated: June 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the main results of the study are published.
• Access Criteria: Anonymized datasets used during the study will be available from the corresponding author upon reasonable request.