Meaning-centered Intervention for Internalizing Symptoms

NCT ID: NCT07058181

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-28
• Study Completion Date: 2026-06-30

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.

Detailed Description

First-year psychology students at the University of Groningen will be screened for depressive and anxiety symptoms. Those with heightened symptoms will be invited via e-mail to participate in the study. After filling out the baseline assessment online, participants will be randomly assigned to either a meaning-centered intervention condition, which will receive a meaning-centered intervention taking place approximately every four days, or a waitlist condition, which will be assigned no task. Participants in the intervention condition will follow six 1-hour online intervention sessions led by a trainer and conduct intervention-related homework assignments. The sessions can be followed in English, Dutch, or German. The intervention aims to increase participants' meaning in life and reduce their internalizing symptoms (i.e. depressive and/or anxiety symptoms). Immediately after the final session (i.e. approximately one month after the baseline assessment), participants in the intervention condition will be asked to fill in the post assessment, which includes the same questionnaires as the baseline assessment. Participants in the waitlist control will be asked to complete the post assessment one month after their baseline assessment. One month after the post assessment, participants in both conditions are asked to fill in same set of questionnaires. Waitlist participants are offered to receive the intervention sessions after the study has finished. Participants are compensated with SONA credits.

Conditions

Depressive and/or Anxiety Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Meaning-centered intervention

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

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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

Waitlist control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Groningen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Heymans Institute

Groningen, , Netherlands

Countries

Netherlands

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

Gravitation 024.004.016

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PSY-2324-S-0451

Identifier Type: -

Identifier Source: org_study_id