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Completed

NCT Number: NCT06462300

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

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.

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Key information

Conditions

Eating Disorder Symptom

Age range

16 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Groningen

Groningen, 9712TS, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

A meaning-centered intervention for young women with weight and shape concerns

Behavioral
  • 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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

Sponsors and collaborators

Lead sponsor

University of Groningen

Other

Registry information

Official study title

Searching for Meaning: A Study Examining the Effect of a Meaning-centered Intervention

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 17, 2024
Registry last updated
Jun 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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