Stress, PsychologicalFOREST-ANCT05688254
Internet-Based Stress Recovery Program for Adolescents
A study testing FOREST-A in people with Stress, Psychological, run by Vilnius University at 1 site in Lithuania.
Trial summary
The study aims to evaluate the feasibility and efficacy of the internet-based stress recovery program for adolescents. Read more about this study
- Who is it for?
- Ages 15 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological
- What is being tested?
- FOREST-A
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteLithuania
- Study dates
- 25 Apr 2023to 30 Jun 2023
- 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 15 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Recent exposure to life-stressor.
- Students of high schools in Lithuania.
- Comprehending Lithuanian.
- Parental and own consent for minor-aged participants (< 18 years)/only own consent for adolescents aged 18 years or older to participate in the study provided.
- Have access to a device (such as a tablet, phone or computer) with an internet connection.
Who cannot join
- Acute psychiatric condition/crisis.
- No recent life-stressor exposure, or low levels of stress.
Trial locations and contacts
1 site in 1 country.
About this study
The study aims to evaluate the feasibility and efficacy of the internet-based stress recovery program for adolescents.
Read the detailed description
The FOREST-A is a third-wave cognitive behavioral therapy and mindfulness-based internet-delivered 4-week psychosocial intervention for recovery from stress, which was initially developed for healthcare workers and is now adapted for adolescents. The program comprises six modules: introduction, relaxation, psychological detachment, mastery, control, and summary, with psychologist engagement on-demand. Each module includes psychoeducation and exercises. The program will be delivered in Lithuanian.
The intervention will be evaluated using the two-arm randomized controlled trial with intervention and care as usual condition at pre-test and post-test.
- Conditions
- Stress, Psychological
- Being tested
- FOREST-A
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOREST-ABehavioural
The internet-based psychosocial intervention will be delivered. The intervention comprises six modules: introduction, relaxation, psychological detachment, mastery, control, and summary, within psychoeducation and exercises in each module. The interactions with psychologists will be on demand. The whole intervention duration will be 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group will get a 4-week online stress recovery intervention. Receives: Behavioral: FOREST-A |
| Control group | No intervention | The control group will take care as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Recovery Experience Questionnaire
The Recovery Experience Questionnaire (Sonnentag \& Fritz, 2007) adapted Child and Adolescent version will be used to measure the changes in recovery from stress experience. It is a self-report measure comprising 16 items, with provided 5-point Likert scale, ranging from Totally disagree (=1) to Totally agree (=5). Total scores may range from 16 to 80, and higher scores will indicate higher recovery.
Measured: Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
Secondary outcomes (5)
The Adjustment Disorder New Module-8 Child and Adolescent Version Questionnaire
The Adjustment Disorder New Module-8 Child and Adolescent Version (Kazlauskas et al., 2018) will be used to measure the changes in symptoms of adjustment disorder, which are described in the International Classification of diseases 11th edition (WHO, 2018). The measure includes a list of 16 potentially stressful events (with binary answers Yes and No, indicating whether the participant has experienced a stressor) and 8 items for adjustment disorder symptoms evaluation (with a 4-point Likert scale ranging from Never (=1) to Often (=4)). Total scores may range from 8 to 32, and higher scores will indicate higher adjustment problems.
Measured: Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
The Generalized Anxiety Disorder-7 scale
The Generalized Anxiety Disorder-7 scale (Spitzer, Kroenke, Williams, \& Löwe, 2007) will be used to measure the changes in generalized anxiety symptoms.The measure comprises 7 items with the possible answers ranging on a 4-point Likert scale from Not at all (=0) to Nearly every day (=3). Total scores may range from 0 to 21. Higher scores will indicate higher generalized anxiety symptoms.
Measured: Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
The Patient Health Questionnaire-9 questionnaire
The Patient Health Questionnaire-9 (Löwe, Kroenke, Herzog, \& Gräfe, 2004) will be used to measure changes in depressive symptoms. The measure comprises 9 items, with provided a 4-point Likert scale, ranging from Not at all (=0) to Nearly every day (=3). Total scores may range from 0 to 27. Higher scores will indicate higher depressive symptoms.
Measured: Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
The WHO-5 Well-being Index Questionnaire
The WHO-5 Well-being Index (Topp, Østergaard, Søndergaard, \& Bech, 2015) will be used to measure changes in general psychological well-being. The measure comprises 5 items with a Likert scale ranging At no time (=0) to All of the time (=5). Total scores may range from 0 to 25. Higher scores will indicate better psychological well-being.
Measured: Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
The Perceived Positive Social Support Scale
The Perceived Positive Social Support Scale (Kazlauskas et al., 2022) will be used to measure changes in social support. The measure comprises 4 items, with provided an 8-point Likert scale ranging from Never (=0) to Always (=7). Total scores may range from 0 to 28. Higher scores will indicate higher perceived positive support.
Measured: Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start25 Apr 2023
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
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 Stress, PsychologicalStudies 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 randomly allocated either to the intervention or control groups. The intervention group will use the intervention and the control will take care as usual.
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vilnius University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paulina Zelviene, PhD, Principal investigator, Vilnius University, Institute of Psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05688254
- Sponsor's protocol ID
- (1.5 E) 250000-S-646
- Acronym
- FOREST-A
- Status last verified
- Jan 2023
- First submitted
- 8 Jan 2023
- Last updated
- 28 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zelviene P, Kairyte A, Dumarkaite A, Nomeikaite A, Kazlauskas E. Internet-based stress recovery intervention for adolescents: study protocol for a randomized controlled trial. Trials. 2023 Mar 8;24(1):174. doi: 10.1186/s13063-023-07188-1.
PubMed 36890560
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-Based Stress Recovery Program for Adolescents
- ClinicalTrials.gov ID
- NCT05688254
- Acronym / sponsor ID
- FOREST-A / (1.5 E) 250000-S-646
- Conditions
- Stress, Psychological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Vilnius UniversityUniversity, hospital or other
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 18 Jan 2023 (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 study aims to evaluate the feasibility and efficacy of the internet-based stress recovery program for adolescents.
Detailed description
The FOREST-A is a third-wave cognitive behavioral therapy and mindfulness-based internet-delivered 4-week psychosocial intervention for recovery from stress, which was initially developed for healthcare workers and is now adapted for adolescents. The program comprises six modules: introduction, relaxation, psychological detachment, mastery, control, and summary, with psychologist engagement on-demand. Each module includes psychoeducation and exercises. The program will be delivered in Lithuanian.
The intervention will be evaluated using the two-arm randomized controlled trial with intervention and care as usual condition at pre-test and post-test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly allocated either to the intervention or control groups. The intervention group will use the intervention and the control will take care as usual.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: FOREST-AThe intervention group will get a 4-week online stress recovery intervention. |
| Control group | No intervention | –The control group will take care as usual. |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Recent exposure to life-stressor.
- Students of high schools in Lithuania.
- Comprehending Lithuanian.
- Parental and own consent for minor-aged participants (< 18 years)/only own consent for adolescents aged 18 years or older to participate in the study provided.
- Have access to a device (such as a tablet, phone or computer) with an internet connection.
Key exclusion criteria (2 listed)
- Acute psychiatric condition/crisis.
- No recent life-stressor exposure, or low levels of stress.
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 |
|---|---|---|
| FOREST-AThe internet-based psychosocial intervention will be delivered. The intervention comprises six modules: introduction, relaxation, psychological detachment, mastery, control, and summary, within psychoeducation and exercises in each module. The interactions with psychologists will be on demand. The whole intervention duration will be 4 weeks. | Behavioural | Intervention group |
Primary outcome
The Recovery Experience Questionnaire
Time frame: Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
The Recovery Experience Questionnaire (Sonnentag \& Fritz, 2007) adapted Child and Adolescent version will be used to measure the changes in recovery from stress experience. It is a self-report measure comprising 16 items, with provided 5-point Likert scale, ranging from Totally disagree (=1) to Totally agree (=5). Total scores may range from 16 to 80, and higher scores will indicate higher recovery.
5 secondary outcomes
The Adjustment Disorder New Module-8 Child and Adolescent Version Questionnaire
Time frame: Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
The Generalized Anxiety Disorder-7 scale
Time frame: Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
The Patient Health Questionnaire-9 questionnaire
Time frame: Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
The WHO-5 Well-being Index Questionnaire
Time frame: Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
The Perceived Positive Social Support Scale
Time frame: Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- Derived from this study: PubMed 36890560Zelviene P, Kairyte A, Dumarkaite A, Nomeikaite A, Kazlauskas E. Internet-based stress recovery intervention for adolescents: study protocol for a randomized controlled trial. Trials. 2023 Mar 8;24(1):174. doi: 10.1186/s13063-023-07188-1.
- Individual participant dataSharing planned: No
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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.
Paulina Zelviene, PhD principal investigator
Vilnius University, Institute of Psychology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FOREST-A in people with Stress, Psychological, run by Vilnius University at 1 site in Lithuania.
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 2 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: finished, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Recovery Experience Questionnaire (time frame: Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up). 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 NCT05688254, 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 28 May 2024.