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

Eating Disorder Symptom Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06462300
• Other study ID #: PSY-2223-S-0010
• Status: Completed
• Phase: N/A
• Start date: October 20, 2022
• Est. completion date: February 6, 2024

Study information

• Verified date: June 2024
• Source: University of Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: February 6, 2024
• Est. primary completion date: February 6, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Eating Disorder Symptom
• Feeding and Eating Disorders

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
Netherlands	University of Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University of Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline (week 1), post-assessment (week 7), follow-up (week 11)
Secondary	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	Baseline (week 1), post-assessment (week 7), follow-up (week 11)
Secondary	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	Baseline (week 1), post-assessment (week 7), follow-up (week 11)
Secondary	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	Baseline (week 1), post-assessment (week 7), follow-up (week 11)
Secondary	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	Baseline (week 1), post-assessment (week 7), follow-up (week 11)
Secondary	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	Baseline (week 1), post-assessment (week 7), follow-up (week 11)
Secondary	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	Baseline (week 1), post-assessment (week 7), follow-up (week 11)
Secondary	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	Baseline (week 1), post-assessment (week 7), follow-up (week 11)
Secondary	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	Baseline (week 1), post-assessment (week 7), follow-up (week 11)