NCT05688254

Brief Summary

The study aims to evaluate the feasibility and efficacy of the internet-based stress recovery program for adolescents.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 18, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

April 25, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

May 28, 2024

Status Verified

January 1, 2023

Enrollment Period

2 months

First QC Date

January 8, 2023

Last Update Submit

May 23, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up

  • The Generalized Anxiety Disorder-7 scale

    Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up

  • The Patient Health Questionnaire-9 questionnaire

    Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up

  • The WHO-5 Well-being Index Questionnaire

    Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up

  • The Perceived Positive Social Support Scale

    Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up

Other Outcomes (1)

  • Program evaluation questions

    Post-treatment (after 4 weeks)

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group will get a 4-week online stress recovery intervention.

Behavioral: FOREST-A

Control group

NO INTERVENTION

The control group will take care as usual.

Interventions

FOREST-ABEHAVIORAL

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.

Intervention group

Eligibility Criteria

Age15 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Acute psychiatric condition/crisis.
  • No recent life-stressor exposure, or low levels of stress.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vilnius University

Vilnius, Lithuania

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Paulina Zelviene, PhD

    Vilnius University, Institute of Psychology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2023

First Posted

January 18, 2023

Study Start

April 25, 2023

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

May 28, 2024

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations