- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07681765
A Psychomotor Group Intervention for Young Adults With Anxiety Symptoms
June 25, 2026 updated by: VIA University College
Development and Feasibility of a Group-based Psychomotor Intervention for Anxiety in Young Adults
The goal of this clinical trial is to learn if a psychomotor (a body-oriented therapy) group intervention can be feasibly delivered to a group of young adults (age 18-35) with anxiety symptoms within a higher educational setting.
The main questions it aims to answer are:
- Is it possible to recruit and retain participants in this intervention?
- Is the intervention acceptable and tolerable to participants?
- Do participants complete the planned sessions and assessments?
Participants will:
- Attend one weekly group session over ten consecutive weeks
- Participate in active and contemplative body-based exercises
- Complete questionnaires about their mental health and interviews about their experiences of participating
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Region Midt
-
Aarhus, Region Midt, Denmark, 8200
- VIA University College
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age between 18 and 34 years
- A score of at least 2 on item 10 of the Anxiety Symptom Scale (indicating the perceived strain of the experienced anxiety symptoms) and at least 1 on one or more of items 1-3 (generalized anxiety symptoms and avoidance behavior)
- Sufficient Danish language proficiency to participate in group sessions and interviews
Exclusion Criteria:
- Physical or psychological conditions that prevents participation in group-based or bodily-activities, such as significant musculoskelatal impairment or current, untreated episodes of psychosis
- Ongoing alcohol or substance abuse
- Concurrent participation in another body-oriented intervention program
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Psychomotor intervention group
|
Ten weekly sessions of a psychomotor therapy group program.
Session duration: 2½ hours.
Group size: 12 participants.
Sessions include psychoeducational content and body-oriented exercises such as breathing exercises, relaxation exercises, body scans, or grounding exercises.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants recruited
Time Frame: For each participant: 20 minutes during the three month enrollment period.
|
Enrollment during a three month period from June 2025 to September 2025.
Enrollment interview was approximately 20 minutes.
Participants had the option of attending a one hour information meeting.
|
For each participant: 20 minutes during the three month enrollment period.
|
|
Number of participants retained
Time Frame: From enrollment to end of intervention at 11 weeks
|
From enrollment to end of intervention at 11 weeks
|
|
|
Attendance
Time Frame: From beginning of intervention to end of intervention at 11 weeks
|
Number of participants attending each of the ten weekly sessions
|
From beginning of intervention to end of intervention at 11 weeks
|
|
Acceptability to participants
Time Frame: Post intervention at 12 weeks
|
Evaluated through qualitative interviews with a duration of 45-60 minutes
|
Post intervention at 12 weeks
|
|
Fidelity of the intervention
Time Frame: From beginning of intervention to end of intervention at 11 weeks
|
The extent to which intervention components were administered as intended.
This was registered by an observer who registered any deviations from a therapy manual.
|
From beginning of intervention to end of intervention at 11 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in Beck Anxiety Inventory
Time Frame: Baseline and post-intervention at 11 weeks
|
21 items rated on a four-point Likert scale with scores ranging rom 0 (no anxiety) to 21 (worst possible anxiety)
|
Baseline and post-intervention at 11 weeks
|
|
Changes in Perceived Stress Scale
Time Frame: Baseline and post-intervention at 11 weeks
|
Ten items rated on a five-point Likert scale with scores ranging from 0 (no stress) - 40 (maximum stress)
|
Baseline and post-intervention at 11 weeks
|
|
Changes i WHO-Five Well-Being Index
Time Frame: Baseline and post-intervention at 11 weeks
|
A five-item measure rated on a six-point Likert scale with scores ranging from 0 (worst possible well-being) to 100 (maximum well-being)
|
Baseline and post-intervention at 11 weeks
|
|
Changes in Multiple Assessment of Interoceptive Awareness
Time Frame: Baseline and post-intervention at 11 weeks
|
Body awareness measured through 32 items across eight subscales rated on a six-point Likert scale, reported as mean scores on each subscale (range 0-5)
|
Baseline and post-intervention at 11 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 12, 2025
Primary Completion (Actual)
December 18, 2025
Study Completion (Actual)
December 18, 2025
Study Registration Dates
First Submitted
June 12, 2026
First Submitted That Met QC Criteria
June 25, 2026
First Posted (Actual)
July 2, 2026
Study Record Updates
Last Update Posted (Actual)
July 2, 2026
Last Update Submitted That Met QC Criteria
June 25, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9001099
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Small scale feasibility study data.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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