NCT07058181

Brief Summary

Young adults with internalizing symptoms will be randomly assigned to a six-session meaning-centered intervention condition or a waitlist condition. Both conditions receive the same questionnaires at baseline, post assessment (intervention condition: immediately after the final session; waitlist: four weeks after baseline), and follow-up. The researchers hypothesize that a meaning-centered intervention for individuals with internalizing symptoms will increase participants' meaning in life and reduce their internalizing symptoms at post assessment and 4-week follow-up when compared to a waitlist condition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
155

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2024

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 28, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 10, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2026

Completed
Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

May 16, 2025

Last Update Submit

March 2, 2026

Conditions

Keywords

meaning-centered interventioninternalizing symptomsyoung adults

Outcome Measures

Primary Outcomes (1)

  • Meaning in Life Questionnaire; Depression, Anxiety and Stress Scales-21

    questionnaire (MLQ: sum score (5-35), 7-point Likert scale (1-7), higher scores indicating higher presence of life meaning; DASS-21: sum score (0-33), 4-point Likert scale (0-3), higher scores indicating higher internalizing symptoms)

    at baseline; post (one month after baseline); one-month follow-up (one month after post)

Secondary Outcomes (1)

  • Dyscontrolled drinking; Three-dimensional meaning

    at baseline; post (one month after baseline); one-month follow-up (one month after post)

Study Arms (2)

Meaning-centered intervention

EXPERIMENTAL

Participants receive a meaning-centered intervention consisting of six 1-hour online sessions led by a trainer.

Behavioral: Meaning-centered intervention for individuals who tend to feel down or anxious

Waitlist control

NO INTERVENTION

No task or intervention is assigned to participants in this arm.

Interventions

Meaning-centered intervention for internalizing symptoms adapted from the intervention "Meaning-centered intervention for youth worrying about their weight and shape". * Six 1-hour individual online sessions, approximately every 4 days * Sessions led by a certified trainer based on intervention manual * Four sources of meaning will be explored: personal life story, dealing with life's limitations, creating one's own life, and meaningful experiences * Participants follow intervention using intervention workbook * Homework assignments designed to deepen participants' experience and reflection on meaning in their daily lives

Meaning-centered intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • heightened internalizing symptoms (depressive and/or anxiety symptoms) as indicated by PHQ-4 total score of 2 or higher

You may not qualify if:

  • receiving psychotherapeutic treatment for a depressive or anxiety disorder
  • suicidality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heymans Institute

Groningen, Provincie Groningen, 9712 TS, Netherlands

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

May 16, 2025

First Posted

July 10, 2025

Study Start

November 28, 2024

Primary Completion

February 23, 2026

Study Completion

February 23, 2026

Last Updated

March 4, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations