- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07803796
Effectiveness of a Self-Guided Intervention for Body Dysmorphia and Positive Psychological Outcomes Among Adolescents
The goal of this clinical trial is to learn if self guided intervention for body dysmorphia works to treat the symptoms and effective in bringing positive psychological outcomes in adolescents. The outcome measures include self compassion, gratitude, mindfulness, positive affect, body satisfaction, body esteem, psychological wellbeing and psychological flexibility. The main questions it aims to answer are:
- Does self guided intervention is effective in reducing the symptoms body dysmorphia?
- What changes it brings in positive psychological outcome measures? Researchers will compare the pretest and posttest results of the positive psychological measures to see if self guided intervention is effective in reducing symptoms of body dysmorphia.
Participants will:
- Be screened out for the symptoms body dysmorphia
- Those having symptoms will be divided in to two groups i.e, experimental and control group
- All the participants will take the pretesting of positive psychological measures
- Then only experimental group will be given six weeks self guided intervention
- After six weeks both groups will be posttested for the positive psychological measures.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
## Detailed Description of the Clinical Trial
The primary objective of this clinical trial is to evaluate the effectiveness of a six-week self-guided psychological intervention designed to reduce the symptoms of Body Dysmorphic Disorder (BDD) among adolescents. The study also aims to investigate whether participation in the intervention contributes to improvements in a range of positive psychological outcomes that are associated with mental health, emotional resilience, and overall psychological functioning.
Body Dysmorphic Disorder is characterized by persistent preoccupation with perceived defects or flaws in one's physical appearance that are either unnoticeable or appear minor to others. These concerns often lead to significant emotional distress, repetitive appearance-related behaviors, social withdrawal, reduced quality of life, and impaired psychological functioning. While therapist-led interventions have demonstrated effectiveness in treating BDD, self-guided interventions may offer a more accessible, cost-effective, and scalable approach, particularly for adolescents who face barriers to receiving professional psychological treatment.
This study seeks to determine whether a structured self-guided intervention can effectively reduce body dysmorphic symptoms while simultaneously promoting positive psychological resources and well-being. Rather than focusing solely on symptom reduction, the intervention adopts a positive psychology perspective by examining improvements in psychological strengths and adaptive functioning.
Specifically, the study will assess changes in the following psychological constructs:
- **Self-compassion**, reflecting an individual's ability to respond to personal imperfections and emotional distress with kindness, understanding, and acceptance rather than self-criticism.
- **Gratitude**, representing appreciation for positive experiences and recognition of beneficial aspects of life.
- **Mindfulness**, referring to present-moment awareness accompanied by non-judgmental acceptance of thoughts, emotions, and bodily experiences.
- **Positive affect**, indicating the frequency and intensity of positive emotional experiences such as enthusiasm, happiness, confidence, and optimism.
- **Body satisfaction**, measuring the degree to which adolescents feel satisfied with their overall physical appearance and individual body features.
- **Body esteem**, assessing positive self-evaluations regarding physical appearance, body image, and self-worth related to one's body.
- **Psychological well-being**, encompassing autonomy, environmental mastery, positive interpersonal relationships, personal growth, purpose in life, and self-acceptance.
**Psychological flexibility**, referring to the ability to remain open to internal experiences while engaging in behaviors that are consistent with personal values and long-term goals.
- Research Questions
The study is designed to address the following research questions:
- Is a six-week self-guided intervention effective in reducing the symptoms of Body Dysmorphic Disorder among adolescents?
- Does participation in the self-guided intervention lead to significant improvements in positive psychological outcomes, including self-compassion, gratitude, mindfulness, positive affect, body satisfaction, body esteem, psychological well-being, and psychological flexibility?
Are there significant differences between adolescents receiving the self-guided intervention and those in the control group following completion of the intervention?
- Study Design
The research will employ a randomized controlled pretest-posttest experimental design.
Initially, adolescent participants will undergo screening using standardized measures to identify the presence and severity of Body Dysmorphic Disorder symptoms. Individuals meeting the predetermined eligibility criteria will be invited to participate in the study.
Eligible participants will then be randomly assigned to one of two groups:
- **Experimental Group**, which will receive the six-week self-guided intervention.
- **Control Group**, which will not receive the intervention during the study period (or will receive treatment as usual/wait-list control, depending on the study protocol).
Before the intervention begins, participants in both groups will complete a comprehensive battery of psychological assessments measuring Body Dysmorphic Disorder symptoms and all selected positive psychological variables. These baseline assessments will establish participants' initial levels of functioning and serve as the pretest measurements.
Participants assigned to the experimental group will subsequently complete the structured six-week self-guided intervention. The intervention will include evidence-based psychological exercises and activities intended to improve body image, encourage adaptive cognitive and emotional processing, cultivate self-compassion and mindfulness, strengthen gratitude, and promote overall psychological well-being. Participants will complete the intervention independently while following standardized instructions provided by the researchers.
The control group will continue with their usual daily routines without receiving the intervention during the same six-week period.
At the conclusion of the intervention, participants in both the experimental and control groups will again complete the same set of psychological assessments. These posttest measurements will allow researchers to examine changes in Body Dysmorphic Disorder symptoms as well as changes across all positive psychological outcome measures.
### Outcome Evaluation
The effectiveness of the intervention will be evaluated by comparing participants' pretest and posttest scores within each group and between the experimental and control groups. Statistical analyses will determine whether the self-guided intervention produces significant reductions in Body Dysmorphic Disorder symptoms and significant improvements in self-compassion, gratitude, mindfulness, positive affect, body satisfaction, body esteem, psychological well-being, psychological flexibility, and overall psychological functioning.
### Participant Procedure
Participants enrolled in the study will complete the following sequence of activities:
- Undergo screening for symptoms of Body Dysmorphic Disorder using standardized assessment instruments.
- Eligible participants who meet the inclusion criteria will provide informed consent (and parental consent where applicable).
- Participants will be randomly allocated to either the experimental group or the control group.
- All participants will complete baseline (pretest) assessments of Body Dysmorphic Disorder symptoms and all positive psychological outcome measures.
- Participants in the experimental group will complete the six-week self-guided intervention, while participants in the control group will not receive the intervention during this period.
- Following completion of the intervention, both groups will complete the posttest assessments using the same psychological instruments administered at baseline.
- Researchers will compare pretest and posttest scores to determine the effectiveness of the intervention in reducing Body Dysmorphic Disorder symptoms and enhancing positive psychological outcomes.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adolescents aged 15 to 18 years
- Male or female participants
- Presence of symptoms of Body Dysmorphic Disorder as indicated by the Body Dysmorphic Disorder Questionnaire (BDDQ)
- Able to read and understand the language in which the study materials and assessment measures are administered
- Willing to participate in the six-week self-guided intervention and complete the required study assessments
- Willing to provide informed assent
- Written informed consent from a parent or legal guardian, where required
- Regular access to the materials required to complete the self-guided intervention
Exclusion Criteria:
- Participants who do not meet the study screening criteria for symptoms of Body Dysmorphic Disorder
- Current participation in another psychological intervention specifically targeting Body Dysmorphic Disorder or body image concerns
- Current participation in another clinical trial or structured intervention that could affect the study outcomes
- Presence of a severe psychiatric or psychological condition that would interfere with participation in the study or completion of the intervention
- Current suicidal ideation or behavior requiring immediate clinical or psychiatric intervention
- Cognitive, developmental, neurological, or intellectual difficulties that prevent the participant from understanding the study procedures or completing the assessment measures
- Inability or unwillingness to complete the six-week intervention
- Inability or unwillingness to complete the pretest and posttest assessments
- Failure to provide informed assent or parental/legal guardian consent, where required
Study Plan
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: Participants receive the six-week self-guided psychological intervention targeting symptoms of BDD
Self-Guided Intervention Participants assigned to the experimental arm will receive a structured six-week self-guided psychological intervention designed to reduce symptoms of Body Dysmorphic Disorder (BDD) and enhance positive psychological functioning. The intervention consists of weekly self-administered modules incorporating evidence-based psychological techniques, including psychoeducation, cognitive restructuring, mindfulness practices, self-compassion exercises, gratitude activities, body image enhancement strategies, behavioral exercises, and psychological flexibility skills. Participants will complete the intervention independently according to the prescribed schedule while continuing their usual daily activities. Outcome measures will be assessed at baseline (pretest) and immediately after completion of the six-week intervention (posttest). Intervention: Self-Guided Psychological Intervention for Body Dysmorphic Disorder (6 weeks) |
Intervention: Self-Guided Psychological Intervention for Body Dysmorphic Disorder (6 weeks) was given to the experimental group |
|
No Intervention: Control Group
Participants assigned to the control arm will not receive the self-guided intervention during the six-week study period and will continue their usual daily routines without any structured psychological treatment provided as part of the study.
They will complete the same baseline (pretest) and post-intervention (posttest) assessments as the experimental group to allow comparison of changes in Body Dysmorphic Disorder symptoms and positive psychological outcomes over time.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Outcome Measure Title: Change in Body Dysmorphic Disorder Symptoms as Measured by the Body Dysmorphic Disorder Questionnaire (BDDQ)
Time Frame: Baseline (Week 0) and immediately after completion of the intervention (Week 6).
|
The primary outcome is the change in the severity of Body Dysmorphic Disorder (BDD) symptoms following completion of the six-week self-guided intervention.
Symptom severity will be assessed using a standardized measure of body dysmorphic symptoms administered at baseline (pretest) and immediately after the intervention (posttest).
The effectiveness of the intervention will be determined by comparing changes in BDD symptom scores between the experimental and control groups.
|
Baseline (Week 0) and immediately after completion of the intervention (Week 6).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in self Compassion measured by The Self-Compassion Scale Youth Version (SCS-Youth)
Time Frame: Baseline (Week 0) and immediately after completion of the intervention (Week 6).
|
Self-compassion will be assessed using the 17-item Self-Compassion Scale-Youth Version (SCS-Y).
Each item is rated on a 5-point scale from 1 (Almost Never) to 5 (Almost Always).
Negatively worded items are reverse-scored.
The total self-compassion score is calculated as the mean of the six subscale means after reverse-scoring the negative components.
The possible mean score ranges from 1 to 5, with higher scores indicating greater self-compassion and lower scores indicating lower self-compassion.
|
Baseline (Week 0) and immediately after completion of the intervention (Week 6).
|
|
Change in Gratitude measured by The Gratitude Questionnaire - Six Item Form (GQ-6)
Time Frame: Baseline (Week 0) and immediately after completion of the intervention (Week 6).
|
Gratitude will be assessed using the six-item Gratitude Questionnaire-Six Item Form (GQ-6).
Items are rated on a 7-point scale from 1 (Strongly Disagree) to 7 (Strongly Agree).
Items 3 and 6 are reverse-scored.
Total scores range from 6 to 42, with higher scores indicating greater dispositional gratitude and lower scores indicating lower dispositional gratitude.
|
Baseline (Week 0) and immediately after completion of the intervention (Week 6).
|
|
Change in Mindfulness measured by Mindfulness Attention Awareness Scale (MAAS)
Time Frame: Baseline (Week 0) and immediately after completion of the intervention (Week 6).
|
Mindfulness will be assessed using the 15-item Mindful Attention Awareness Scale (MAAS), which measures the frequency of open and receptive attention to and awareness of present-moment experiences.
Items are rated on a 6-point response scale from 1 (Almost Always) to 6 (Almost Never), with scoring procedures resulting in a mean score ranging from 1 to 6. Higher scores indicate greater mindful attention and awareness, whereas lower scores indicate lower levels of mindfulness.
|
Baseline (Week 0) and immediately after completion of the intervention (Week 6).
|
|
Change in positive Affect measured by he Positive and Negative Affect Schedule (PANAS)
Time Frame: Baseline (Week 0) and immediately after completion of the intervention (Week 6).
|
Positive and negative affect will be assessed using the Positive and Negative Affect Schedule (PANAS).
The PANAS contains separate Positive Affect and Negative Affect subscales, each consisting of 10 items scored from 1 to 5. Each subscale has a possible score range of 10 to 50.
Higher Positive Affect scores indicate greater positive affect.
Higher Negative Affect scores indicate greater negative affect and therefore represent a less favorable outcome when evaluating improvement in psychological functioning.
|
Baseline (Week 0) and immediately after completion of the intervention (Week 6).
|
|
Change in psychological wellbeing measured by Warwick Edinburgh Mental Well-Being Scale
Time Frame: Baseline (Week 0) and immediately after completion of the intervention (Week 6).
|
Mental well-being will be assessed using the 14-item Warwick-Edinburgh Mental Well-Being Scale (WEMWBS).
Each item is rated from 1 to 5. Total scores range from 14 to 70.
All items are positively scored, with higher scores indicating greater mental well-being and lower scores indicating lower mental well-being.
|
Baseline (Week 0) and immediately after completion of the intervention (Week 6).
|
|
Change in psychological flexibility measured by Acceptance and Fusion Questionnaire for Youth (AFQ-Y)
Time Frame: Baseline (Week 0) and immediately after completion of the intervention (Week 6).
|
Psychological inflexibility will be assessed using the 17-item Acceptance and Fusion Questionnaire for Youth (AFQ-Y).
Items are rated on a 5-point scale from 0 to 4. Total scores range from 0 to 68, with higher scores indicating greater psychological inflexibility, experiential avoidance, and cognitive fusion.
Lower scores indicate greater psychological flexibility and therefore represent a more favorable outcome in this study.
|
Baseline (Week 0) and immediately after completion of the intervention (Week 6).
|
|
Change in body esteem measured by Body Esteem Scale for Adolescents and Adults (BESAA)
Time Frame: Baseline (Week 0) and immediately after completion of the intervention (Week 6).
|
Body esteem will be assessed using the 23-item Body-Esteem Scale for Adolescents and Adults (BESAA).
Items are rated on a 5-point scale from 0 (Never) to 4 (Always), with negatively worded items reverse-scored.
Body esteem may be reported using the mean score across items, ranging from 0 to 4. Higher scores indicate greater positive body esteem, whereas lower scores indicate lower body esteem.
The BESAA comprises Appearance, Weight, and Attribution dimensions.
|
Baseline (Week 0) and immediately after completion of the intervention (Week 6).
|
|
Change in body satisfaction measured by Body Image Satisfaction Rating Scale
Time Frame: Baseline (Week 0) and immediately after completion of the intervention (Week 6).
|
Body image satisfaction will be assessed using the Body Image Satisfaction Rating Scale, an adapted measure based on the Body-Image Questionnaire (BIQ) described by Koleck et al. (2002).
The adapted measure used in this study contains 18 items rated using a 5-point response format.
Total scores range from 0 to 36, with higher scores indicating greater body image satisfaction and lower scores indicating greater body image dissatisfaction.
The original Body-Image Questionnaire described by Koleck et al. consisted of 19 items and assessed general body satisfaction; therefore, the present study will identify the instrument as an adapted version where applicable.
|
Baseline (Week 0) and immediately after completion of the intervention (Week 6).
|
Collaborators and Investigators
Study record dates
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Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
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Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
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More Information
Terms related to this study
Other Study ID Numbers
- National U Modern Languages
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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