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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-10

Study Completion Date

2025-12-20

Brief Summary

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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.

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Detailed Description

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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

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Posttraumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Internet-based guided programme Spring

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

Internet-based guided programme Spring

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No