Depressive and/or Anxiety SymptomsNCT07058181
Meaning-centered Intervention for Internalizing Symptoms
A study testing Meaning-centered intervention for individuals who tend to feel down or anxious in people with Depressive and/or Anxiety Symptoms, run by University of Groningen at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive and/or Anxiety Symptoms
- What is being tested?
- Meaning-centered intervention for individuals who tend to feel down or anxious
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteNetherlands
- Study dates
- 28 Nov 2024to 23 Feb 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- heightened internalizing symptoms (depressive and/or anxiety symptoms) as indicated by PHQ-4 total score of 2 or higher
Who cannot join
- receiving psychotherapeutic treatment for a depressive or anxiety disorder
- suicidality
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Heymans Institute
Groningen, Provincie Groningen, 9712 TS
About this study
Official title: A Meaning-centered Intervention for Individuals Who Tend to Feel Down or Anxious
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.
Read the 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
- Being tested
- Meaning-centered intervention for individuals who tend to feel down or anxious
- Keywords
- meaning-centered intervention, internalizing symptoms, young adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meaning-centered intervention for individuals who tend to feel down or anxiousBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Meaning-centered intervention | Experimental | Participants receive a meaning-centered intervention consisting of six 1-hour online sessions led by a trainer. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: at baseline; post (one month after baseline); one-month follow-up (one month after post)
Secondary outcomes (1)
Dyscontrolled drinking; Three-dimensional meaning
questionnaire (Dyscontrolled drinking: sum score (3-27), 9-point Likert scale (1-9), higher scores indicating higher dyscontrolled drinking; Three-dimensional meaning: sum score (11-77), 7-Point Likert scale (1-7), higher scores indicating higher life meaning)
Measured: at baseline; post (one month after baseline); one-month follow-up (one month after post)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start28 Nov 2024
- Primary completion23 Feb 2026
- Study completion23 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive and/or Anxiety SymptomsStudies 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
- Masking
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Amsterdam
- Responsible party
- Principal investigator, Marcel Näther, University of Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07058181
- Sponsor's protocol ID
- PSY-2324-S-0451
- Other IDs
- Gravitation 024.004.016
- Status last verified
- Mar 2026
- First submitted
- 16 May 2025
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Meaning-centered Intervention for Individuals Who Tend to Feel Down or Anxious
- ClinicalTrials.gov ID
- NCT07058181
- Acronym / sponsor ID
- PSY-2324-S-0451
- Conditions
- Depressive and/or Anxiety Symptoms
- Keywords
- meaning-centered intervention, internalizing symptoms, young adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- University of GroningenUniversity, hospital or other
- Collaborators
- University of Amsterdam
- Study start
- 28 Nov 2024 (actual)
- Primary completion
- 23 Feb 2026 (actual)
- Study completion
- 23 Feb 2026 (actual)
- First posted
- 10 Jul 2025 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meaning-centered intervention | Experimental | Behavioral: Meaning-centered intervention for individuals who tend to feel down or anxiousParticipants receive a meaning-centered intervention consisting of six 1-hour online sessions led by a trainer. |
| Waitlist control | No intervention | –No task or intervention is assigned to participants in this arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- heightened internalizing symptoms (depressive and/or anxiety symptoms) as indicated by PHQ-4 total score of 2 or higher
Key exclusion criteria (2 listed)
- receiving psychotherapeutic treatment for a depressive or anxiety disorder
- suicidality
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 |
|---|---|---|
| Meaning-centered intervention for individuals who tend to feel down or anxiousMeaning-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 | Behavioural | Meaning-centered intervention |
Primary outcome
Meaning in Life Questionnaire; Depression, Anxiety and Stress Scales-21
Time frame: at baseline; post (one month after baseline); one-month follow-up (one month after post)
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)
1 secondary outcome
Dyscontrolled drinking; Three-dimensional meaning
Time frame: at baseline; post (one month after baseline); one-month follow-up (one month after post)
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 4 Mar 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meaning-centered intervention for individuals who tend to feel down or anxious in people with Depressive and/or Anxiety Symptoms, run by University of Groningen at 1 site in Netherlands.
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 1 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 4 Mar 2026. 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 Netherlands. 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?
Meaning in Life Questionnaire; Depression, Anxiety and Stress Scales-21 (time frame: at baseline; post (one month after baseline); one-month follow-up (one month after post)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Mar 2026.