Depression and/or Anxiety SymptomsNCT07714954
Replication: Meaning-centered Intervention for Internalizing Symptoms
A study testing Meaning-centered intervention for individuals who tend to feel down or anxious in people with Depression and/or Anxiety Symptoms, run by University of Groningen.
Trial summary
Young adults who experience depression and/or anxiety symptoms (i.e., internalizing symptoms) will be randomly allocated to a six-session meaning-centered intervention condition or a waitlist condition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression 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
- 140 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 (depression and/or anxiety symptoms) as indicated by PHQ-4 score of 2 or above on either the anxiety or depression subscale
Who cannot join
- receiving psychotherapeutic treatment for a depressive or anxiety disorder
- suicidality
About this study
Official title: Testing the Efficacy of a Meaning-centered Intervention for Individuals Who Tend to Feel Down or Anxious: a Replication
Young adults who experience depression and/or anxiety symptoms (i.e., internalizing symptoms) will be randomly allocated 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 depression 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. 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. Additionally, they will be ask to provide feedback about the intervention regarding session and homework content. 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. This study will replicate a previous study initially testing the meaning-centered intervention (https://clinicaltrials.gov/study/NCT07058181?aggFilters=status:,phase:\&tab=researcher#trial-description).
- Conditions
- Depression and/or Anxiety Symptoms
- Being tested
- Meaning-centered intervention for individuals who tend to feel down or anxious
- Keywords
- meaning in life, meaning-centered intervention, internalizing symptoms, depression symptoms, anxiety symptoms
- Medical subject headings
- Depression, Anxiety Disorders
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
Also called 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 the 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.
* Interventions: Behavioral: Meaning-centered intervention for individuals who tend to feel down or anxious 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.
Depression Anxiety Stress Scale (DASS-21)
self-report questionnaire: DASS-21: sum score (0-63), 4-point Likert scale (0-3), higher scores indicating higher internalizing symptoms)
Measured: Time Frame: at baseline; post (one month after baseline); one-month follow-up (one month after post)
Meaning in Life Questionnaire (MLQ); presence of meaning subscale
self-report questionnaire: MLQ: sum score (5-35), 7-point Likert scale (1-7), higher scores indicating higher presence of life meaning
Measured: Time Frame: 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 posted20 Jul 2026
- Study startOct 2026 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression 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
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07714954
- Sponsor's protocol ID
- PSY-2526-S-0246
- Status last verified
- May 2026
- First submitted
- 23 Jun 2026
- Last updated
- 14 Aug 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 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Efficacy of a Meaning-centered Intervention for Individuals Who Tend to Feel Down or Anxious: a Replication
- ClinicalTrials.gov ID
- NCT07714954
- Acronym / sponsor ID
- PSY-2526-S-0246
- Conditions
- Depression and/or Anxiety Symptoms
- Keywords
- meaning in life, meaning-centered intervention, internalizing symptoms, depression symptoms, anxiety symptoms
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of GroningenUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 20 Jul 2026 (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 who experience depression and/or anxiety symptoms (i.e., internalizing symptoms) will be randomly allocated 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 depression 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. 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. Additionally, they will be ask to provide feedback about the intervention regarding session and homework content. 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. This study will replicate a previous study initially testing the meaning-centered intervention (https://clinicaltrials.gov/study/NCT07058181?aggFilters=status:,phase:\&tab=researcher#trial-description).
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 anxious* Participants receive a meaning-centered intervention consisting of six 1-hour online sessions led by a trainer. * Interventions: 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. |
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 (depression and/or anxiety symptoms) as indicated by PHQ-4 score of 2 or above on either the anxiety or depression subscale
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 anxiousAlso: 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 the workbook * Homework assignments designed to deepen participants' experience and reflection on meaning in their daily lives | Behavioural | Meaning-centered intervention |
Primary outcome
Depression Anxiety Stress Scale (DASS-21)
Time frame: Time Frame: at baseline; post (one month after baseline); one-month follow-up (one month after post)
self-report questionnaire: DASS-21: sum score (0-63), 4-point Likert scale (0-3), higher scores indicating higher internalizing symptoms)
Meaning in Life Questionnaire (MLQ); presence of meaning subscale
Time frame: Time Frame: at baseline; post (one month after baseline); one-month follow-up (one month after post)
self-report questionnaire: MLQ: sum score (5-35), 7-point Likert scale (1-7), higher scores indicating higher presence of life meaning
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Depression and/or Anxiety Symptoms, run by University of Groningen.
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: opening soon, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Depression Anxiety Stress Scale (DASS-21) (time frame: Time Frame: at baseline; post (one month after baseline); one-month follow-up (one month after post)). The study lists 2 primary outcomes in all. 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 14 Aug 2026.