Eating Disorder SymptomNCT06462300
Meaning-centered Intervention for Young Women With Weight and Shape Concerns
A study testing A meaning-centered intervention for young women with weight and shape concerns in people with Eating Disorder Symptom, run by University of Groningen at 1 site in Netherlands.
Trial summary
Female participants with weight and shape concerns will either receive a six-week meaning-centered intervention led by a trainer or be allocated to a waitlist condition. They will receive the same questionnaires at three time points: Before the intervention, immediately after, and four weeks later. Read more about this study
- Who is it for?
- Ages 16 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Eating Disorder Symptom
- What is being tested?
- A meaning-centered intervention for young women with weight and shape concerns
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteNetherlands
- Study dates
- 20 Oct 2022to 6 Feb 2024
- 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 16 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- When screened with the Weight Concerns Scale (WCS; Killen et al., 1994) and when scores of all five items were adjusted to equal a maximum score of 20, leading to a total range between 0 and 100 (cf. Jacobi et al., 2004), participant are eligible if they answer "always" or "often" to the item "Do you ever feel fat?" or have a total score ≥ 47 on the WCS or both
Who cannot join
- Current treatment for eating disorder
- not fluent in English, Dutch, or German
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Searching for Meaning: A Study Examining the Effect of a Meaning-centered Intervention
Female participants with weight and shape concerns will either receive a six-week meaning-centered intervention led by a trainer or be allocated to a waitlist condition. They will receive the same questionnaires at three time points: Before the intervention, immediately after, and four weeks later.
The researchers hypothesize that a meaning-centered intervention for young women with weight and shape issues will increase participants meaning in life and decrease their eating disorder symptoms immediately after the intervention and at 4-week follow-up when compared to a waitlist condition.
Read the detailed description
Female first-year psychology students at the University of Groningen will be screened for weight and shape concerns. Those scoring in the clinically relevant range will be invited to participate in the study. After filling out the baseline measures online, the participants will be randomly allocated to a waitlist or an intervention condition. Participants in the intervention condition will follow a weekly 1-hour online intervention with a trainer for six weeks, including homework assignments. In this intervention, the aim is to increase meaning in life and decrease eating disorder symptoms. All study materials will be offered in English, Dutch, or German. Immediately after the intervention and four weeks later, the participants will receive the same questionnaires again as at baseline. The waitlist participants will not receive any intervention during the six-week period between baseline and post-assessment, but receive the same questionnaires in the same timeframe. Waitlist participants will also have the option to receive the intervention after the study has been finished.
- Conditions
- Eating Disorder Symptom
- Being tested
- A meaning-centered intervention for young women with weight and shape concerns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A meaning-centered intervention for young women with weight and shape concernsBehavioural
- adapted version of the manualized meaning-centered psychotherapy for cancer patients developed by van der Spek et al. (2017)
- six weekly individual online sessions, each lasting one hour
- sessions led by a certified trainer
- four sources of meaning will be explored: personal life story, dealing with life's limitations, creating one's own life, and meaningful experiences
- homework assignments designed to deepen participants' experience and reflection on meaning in their daily lives
| Study group | Role | What they receive |
|---|---|---|
| Meaning-centered intervention condition | Experimental | The group of participants receiving the meaning-centered intervention Receives: Behavioral: A meaning-centered intervention for young women with weight and shape concerns |
| Waitlist control condition | No intervention | The group of participants not receiving an intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Meaning in life
Presence of meaning in life subscale of Meaning in Life Questionnaire (Steger et al., 2006); average of 5 items with 7-point Likert scale (minimum: 1; maximum 7); the higher the score, the higher the presence of life meaning
Measured: Baseline (week 1), post-assessment (week 7), follow-up (week 11)
Secondary outcomes (8)
Tripartite domain of meaning in life: Comprehension
Comprehension subscale of Multidimensional Existential Meaning Measure (George \& Park, 2016); average of 5 items on 7-point Likert scale (minimum: 1; maximum: 7); the higher the score, the higher the sense of Comprehension
Measured: Baseline (week 1), post-assessment (week 7), follow-up (week 11)
Tripartite domain of meaning in life: Purpose
Purpose subscale of Multidimensional Existential Meaning Measure (George \& Park, 2016); average of 5 items on 7-point Likert scale (minimum: 1; maximum: 7); the higher the score, the higher the sense of Purpose
Measured: Baseline (week 1), post-assessment (week 7), follow-up (week 11)
Tripartite domain of meaning in life: Mattering
Mattering subscale of Multidimensional Existential Meaning Measure (George \& Park, 2016); average of 5 items on 7-point Likert scale (minimum: 1; maximum: 7); the higher the score, the higher the sense of Mattering
Measured: Baseline (week 1), post-assessment (week 7), follow-up (week 11)
Eating disorder symptoms
Global score of Eating Disorder Examination-Questionnaire (Fairburn \& Beglin, 2008); average score of 22 items on a 7-point Likert scale (minimum: 0; maximum: 6); the higher the score, the more severe the eating disorder symptomatology
Measured: Baseline (week 1), post-assessment (week 7), follow-up (week 11)
Internalizing symptoms
Total score of Depression Anxiety Stress Scales-21 (Lovibond \& Lovibond, 1995); sum score of 21 items on a 4-point Likert scale (minimum: 0; maximum: 63); the higher the score, the more severe the internalizing symptomatology
Measured: Baseline (week 1), post-assessment (week 7), follow-up (week 11)
Depressive symptoms
Depression subscale of Depression Anxiety Stress Scales-21 (Lovibond \& Lovibond, 1995); sum score of 7 items on a 4-point Likert scale (minimum: 0; maximum: 21); the higher the score, the more severe the depressive symptomatology
Measured: Baseline (week 1), post-assessment (week 7), follow-up (week 11)
Anxiety symptoms
Anxiety subscale of Depression Anxiety Stress Scales-21 (Lovibond \& Lovibond, 1995); sum score of 7 items on a 4-point Likert scale (minimum: 0; maximum: 21); the higher the score, the more severe the anxiety symptoms
Measured: Baseline (week 1), post-assessment (week 7), follow-up (week 11)
Stress symptoms
Stress subscale of Depression Anxiety Stress Scales-21 (Lovibond \& Lovibond, 1995); sum score of 7 items on a 4-point Likert scale (minimum: 0; maximum: 21); the higher the score, the more severe the stress symptoms
Measured: Baseline (week 1), post-assessment (week 7), follow-up (week 11)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start20 Oct 2022
- Primary completion6 Feb 2024
- Study completion6 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating Disorder SymptomStudies 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
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06462300
- Sponsor's protocol ID
- PSY-2223-S-0010
- Status last verified
- Jun 2024
- First submitted
- 3 Jun 2024
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlies the results in the finalized publication will be made available
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Searching for Meaning: A Study Examining the Effect of a Meaning-centered Intervention
- ClinicalTrials.gov ID
- NCT06462300
- Acronym / sponsor ID
- PSY-2223-S-0010
- Conditions
- Eating Disorder Symptom
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- University of GroningenUniversity, hospital or other
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- 6 Feb 2024 (actual)
- Study completion
- 6 Feb 2024 (actual)
- First posted
- 17 Jun 2024 (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.
Female participants with weight and shape concerns will either receive a six-week meaning-centered intervention led by a trainer or be allocated to a waitlist condition. They will receive the same questionnaires at three time points: Before the intervention, immediately after, and four weeks later.
The researchers hypothesize that a meaning-centered intervention for young women with weight and shape issues will increase participants meaning in life and decrease their eating disorder symptoms immediately after the intervention and at 4-week follow-up when compared to a waitlist condition.
Detailed description
Female first-year psychology students at the University of Groningen will be screened for weight and shape concerns. Those scoring in the clinically relevant range will be invited to participate in the study. After filling out the baseline measures online, the participants will be randomly allocated to a waitlist or an intervention condition. Participants in the intervention condition will follow a weekly 1-hour online intervention with a trainer for six weeks, including homework assignments. In this intervention, the aim is to increase meaning in life and decrease eating disorder symptoms. All study materials will be offered in English, Dutch, or German. Immediately after the intervention and four weeks later, the participants will receive the same questionnaires again as at baseline. The waitlist participants will not receive any intervention during the six-week period between baseline and post-assessment, but receive the same questionnaires in the same timeframe. Waitlist participants will also have the option to receive the intervention after the study has been finished.
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 condition | Experimental | Behavioral: A meaning-centered intervention for young women with weight and shape concernsThe group of participants receiving the meaning-centered intervention |
| Waitlist control condition | No intervention | –The group of participants not receiving an intervention |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- When screened with the Weight Concerns Scale (WCS; Killen et al., 1994) and when scores of all five items were adjusted to equal a maximum score of 20, leading to a total range between 0 and 100 (cf. Jacobi et al., 2004), participant are eligible if they answer "always" or "often" to the item "Do you ever feel fat?" or have a total score ≥ 47 on the WCS or both
Key exclusion criteria (2 listed)
- Current treatment for eating disorder
- not fluent in English, Dutch, or German
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 |
|---|---|---|
| A meaning-centered intervention for young women with weight and shape concerns* adapted version of the manualized meaning-centered psychotherapy for cancer patients developed by van der Spek et al. (2017) * six weekly individual online sessions, each lasting one hour * sessions led by a certified trainer * four sources of meaning will be explored: personal life story, dealing with life's limitations, creating one's own life, and meaningful experiences * homework assignments designed to deepen participants' experience and reflection on meaning in their daily lives | Behavioural | Meaning-centered intervention condition |
Primary outcome
Meaning in life
Time frame: Baseline (week 1), post-assessment (week 7), follow-up (week 11)
Presence of meaning in life subscale of Meaning in Life Questionnaire (Steger et al., 2006); average of 5 items with 7-point Likert scale (minimum: 1; maximum 7); the higher the score, the higher the presence of life meaning
8 secondary outcomes
Tripartite domain of meaning in life: Comprehension
Time frame: Baseline (week 1), post-assessment (week 7), follow-up (week 11)
Tripartite domain of meaning in life: Purpose
Time frame: Baseline (week 1), post-assessment (week 7), follow-up (week 11)
Tripartite domain of meaning in life: Mattering
Time frame: Baseline (week 1), post-assessment (week 7), follow-up (week 11)
Eating disorder symptoms
Time frame: Baseline (week 1), post-assessment (week 7), follow-up (week 11)
Internalizing symptoms
Time frame: Baseline (week 1), post-assessment (week 7), follow-up (week 11)
Depressive symptoms
Time frame: Baseline (week 1), post-assessment (week 7), follow-up (week 11)
Anxiety symptoms
Time frame: Baseline (week 1), post-assessment (week 7), follow-up (week 11)
Stress symptoms
Time frame: Baseline (week 1), post-assessment (week 7), follow-up (week 11)
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 17 Jun 2024.
- Individual participant dataSharing planned: Yes. All IPD that underlies the results in the finalized publication will be made available
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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 A meaning-centered intervention for young women with weight and shape concerns in people with Eating Disorder Symptom, 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 17 Jun 2024. 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 (time frame: Baseline (week 1), post-assessment (week 7), follow-up (week 11)). 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 17 Jun 2024.