Meaning-centered Intervention for Young Women With Weight and Shape Concerns

June 12, 2024 updated by: University of Groningen

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

166

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

      • Groningen, Netherlands, 9712TS
        • University of Groningen

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

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Current treatment for eating disorder
  • not fluent in English, Dutch, or German

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Meaning-centered intervention condition
The group of participants receiving the meaning-centered intervention
  • 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
No Intervention: Waitlist control condition
The group of participants not receiving an intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline (week 1), post-assessment (week 7), follow-up (week 11)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tripartite domain of meaning in life: Comprehension
Time Frame: Baseline (week 1), post-assessment (week 7), follow-up (week 11)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
Baseline (week 1), post-assessment (week 7), follow-up (week 11)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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)

October 20, 2022

Primary Completion (Actual)

February 6, 2024

Study Completion (Actual)

February 6, 2024

Study Registration Dates

First Submitted

June 3, 2024

First Submitted That Met QC Criteria

June 12, 2024

First Posted (Actual)

June 17, 2024

Study Record Updates

Last Update Posted (Actual)

June 17, 2024

Last Update Submitted That Met QC Criteria

June 12, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSY-2223-S-0010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlies the results in the finalized publication will be made available

IPD Sharing Time Frame

Starting 6 months after publication

IPD Sharing Access Criteria

Access will be given based on individual requests

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • ANALYTIC_CODE

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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