- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07058181
- Original Trial
Meaning-centered Intervention for Internalizing Symptoms
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Provincie Groningen
-
Groningen, Provincie Groningen, Netherlands, 9712 TS
- Heymans Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Meaning-centered intervention
Participants receive a meaning-centered intervention consisting of six 1-hour online sessions led by a trainer.
|
Meaning-centered intervention for internalizing symptoms adapted from the intervention "Meaning-centered intervention for youth worrying about their weight and shape".
|
|
No Intervention: Waitlist control
No task or intervention is assigned to participants in this arm.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
at baseline; post (one month after baseline); one-month follow-up (one month after post)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dyscontrolled drinking; Three-dimensional meaning
Time Frame: at baseline; post (one month after baseline); one-month follow-up (one month after post)
|
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)
|
at baseline; post (one month after baseline); one-month follow-up (one month after post)
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PSY-2324-S-0451
- Gravitation 024.004.016 (Other Grant/Funding Number: NWO)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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