- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07589621
Safety Behavior Fading Versus Progressive Muscle Relaxation for Appearance Concerns
29. maj 2026 opdateret af: Jesse Cougle, Florida State University
Safety Behavior Fading Versus Progressive Muscle Relaxation for Appearance Concerns: A Randomized Clinical Trial of Digital Interventions
The current study aims to explore the efficacy of a text message based safety behavior fading intervention compared to a progressive muscle relaxation intervention for appearance concerns.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Appearance-related safety behavior fading intervention procedures will follow methodology previously used in the Cougle Lab.
The safety behavior fading intervention is designed to target a decrease or elimination of appearance-related safety behaviors.
Individuals randomly assigned to the safety behavior fading condition will receive instructions to decrease or eliminate their endorsed appearance-related safety behaviors.
In addition, they will receive daily reminders via text message to decrease these behaviors, along with a safety behavior monitoring checklist in which the participant indicates the extent to which they decreased and/or eliminated each safety behavior over the previous day.
The daily reminder will include the following language: "Hi!
This is a friendly reminder to avoid using your checklist behaviors.
Please tap the link below to access today's checklist: [link to checklist]."
Text messages will be delivered using EZtexting a text messaging platform used for research and marketing.
Note that no identifying information will be included in this platform.
Each participants phone number will be accompanied with a anonymized ID code.
Individuals randomly assigned to the progressive muscle relaxation condition will be instructed to try and practice it daily for the 28 days.
They will also receive daily text messages to remind them to practice relaxation and they can log which of the 10 different muscle groups they tensed and released in the past day.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
300
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Tapan Patel, Master of Science
- Telefonnummer: 863-517-2584
- E-mail: patel@psy.fsu.edu
Studiesteder
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Florida
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Tallahassee, Florida, Forenede Stater, 32308
- Rekruttering
- Florida State University
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Kontakt:
- Tapan Patel, Master of Science
- Telefonnummer: 8635172584
- E-mail: patel@psy.fsu.edu
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- being between the ages of 18 and 65 years old
- having an internet-capable smart-phone
- scoring at or above the empirical cutoff for appearance concerns measured by the Social Appearance Anxiety Scale (i.e., 52)
Exclusion Criteria:
- changes in psychotropic medication in the last 4 weeks
- failing attention checks in baseline data collection
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Sikkerhedsadfærd falmer
Enkeltpersoner, der tilfældigt tildeles til sikkerhedsadfærd, falmende tilstand vil modtage instruktioner for at reducere eller eliminere deres godkendte udseende-relaterede sikkerhedsadfærd.
Derudover vil de modtage daglige påmindelser via sms for at reducere denne opførsel sammen med en kontrol af sikkerhedsadfærdsovervågning, hvor deltageren angiver, i hvilket omfang de engagerede sig i hver sikkerhedsadfærd i løbet af den foregående dag.
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Deltagerne bliver bedt om at reducere eller eliminere sikkerhedsadfærd via SMS-påmindelser og tjeklister for at overvåge fremskridt.
Andre navne:
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Aktiv komparator: Progressive Muscle Relaxation
Participants in this condition will be instructed to try and practice progressive muscle relaxation daily for 28 days.
To match safety behavior fading they will also receive daily text messages to remind them to practice relaxation and they can log which of the 10 different muscle groups they tensed and released in the past day.
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Participants are asked to practice relaxation daily via text message reminder and checklists to monitor progress.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Social Phobia Inventory (Spin; Connor et al., 2000)
Tidsramme: Dag 0, dag 28, dag 56
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Selvrapporteringsskala, der måler sociale angstsymptomer.
Resultater spænder fra 0 til 68 med højere score, hvilket indikerer højere niveauer af social angst.
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Dag 0, dag 28, dag 56
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Udseende adfærd tjekliste over uge-version (forfatter konstrueret)
Tidsramme: Dag 0, dag 28, dag 56
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Selvrapporteringsskala, der bruges til at måle hyppigheden af at engagere sig i udseende-relateret sikkerhedsadfærd.
Denne skala bruges som en manipulationskontrol.
Hver vare er klassificeret i en skala 0 til 10.
De samlede scoringer spænder fra 0 til 130 med højere score, hvilket indikerer større engagement i udseende-relateret sikkerhedsadfærd
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Dag 0, dag 28, dag 56
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The Social Appearance Anxiety Scale (SAAS)
Tidsramme: Day 0, Day 28, Day 56
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Self-report scale that measures appearance anxiety symptoms.
Scores range from 16 to 80 with higher scores indicating higher levels of appearance concerns.
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Day 0, Day 28, Day 56
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Appearance Anxiety Inventory (AAI; Veale et al., 2014)
Tidsramme: Day 0, Day 28, Day 56
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Self-report scale that measures of body dysmorphic symptoms.
Scores range from 0 to 40 with higher scores indicating higher levels of body dysmorphic symptoms.
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Day 0, Day 28, Day 56
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Eating Disorder-15 (ED-15; Tatham et al., 2015).
Tidsramme: Day 0, Day 28, Day 56
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Self-report scale that measures eating disorder symptoms.
Scores range from 0 to 90 with higher scores indicating higher levels of eating pathology.
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Day 0, Day 28, Day 56
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The Eating Disorder Inventory-Body Dissatisfaction (EDI; Garner et al., 1983).
Tidsramme: Day 0, Day 28, Day 56
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Self-report scale for measuring body dissatisfaction for use in clinical outcome studies.
Each item is rated on a 0-5 scale with a total score range of 9-54 with higher scores indicating greater drive for thinness, bulimia, and body dissatisfaction.
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Day 0, Day 28, Day 56
|
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Credibility and Expectancy Questionnaire (CEQ; Devilly & Borkovec, 2000).
Tidsramme: Day 0
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Self-report scale for measuring treatment expectancy and rationale credibility for use in clinical outcome studies.
Three items are rated on a 0-10 scale and one item is rated on a 0-100 scale with higher scores meaning greater expectancy and credibility.
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Day 0
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Center for Epidemiologic Studies Depression Scale-10 (CESD; Andreson, 1994)
Tidsramme: Dag 0, dag 28, dag 56
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Selvrapportmål for depression symptomens sværhedsgrad.
Hver vare er klassificeret i en skala 0 til 3.
De samlede scoringer spænder fra 0 til 30 med højere score, hvilket indikerer større depressionens sværhedsgrad.
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Dag 0, dag 28, dag 56
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Generalized Anxiety Disorder-7 (GAD-7; Spitzer et al., 2006)
Tidsramme: Day 0, Day 28, Day 56
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Self-report measure of anxiety symptom severity.
Each item is rated on a 0 to 3 scale.
Total scores range from 0 to 28 with higher scores indicating greater anxiety severity.
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Day 0, Day 28, Day 56
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Appearance Preference Task
Tidsramme: Day 0, Day 28, Day 56
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Computerized forced-choice task measuring appearance importance relative to other favorable characteristics.
The APT randomly presents a series of 33 word pairs and asks the participant to select the concept that is more important to them.
Each pair consists of a positive appearance-related adjective and a positive character trait unrelated to appearance (e.g., beautiful-responsible).
Higher scores indicate greater endorsement of appearance words.
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Day 0, Day 28, Day 56
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Social Interaction Scale (Author Constructed)
Tidsramme: Day 0, Day 28, Day 56
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Single-item self-report scale that the extent to which individuals engage with their social support networks.
This question asks: "what percentage of your time awake did you spend interacting with others this past week (0% =No time at all, 100% =all of the time)?"
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Day 0, Day 28, Day 56
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Body Dysmorphic Disorder Symptom Scale-Cognitive Subscale (Wilhelm et al., 2016)
Tidsramme: Day 0, Day 28, Day 56
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Self-report scale that measures cognitions related to body dysmorphic disorder.
Scores range from 0 to 190 with higher scores indicating higher levels of maladaptive cognitions related to body dysmorphic disorder.
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Day 0, Day 28, Day 56
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
29. maj 2026
Primær færdiggørelse (Anslået)
1. december 2026
Studieafslutning (Anslået)
1. december 2026
Datoer for studieregistrering
Først indsendt
11. maj 2026
Først indsendt, der opfyldte QC-kriterier
11. maj 2026
Først opslået (Faktiske)
15. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Psykiske lidelser
- Tegn og symptomer, fordøjelsessystemet
- Fobiske lidelser
- Angstlidelser
- Somatoforme lidelser
- Patologiske tilstande, tegn og symptomer
- Tegn og symptomer
- Fobi, social
- Ernærings- og spiseforstyrrelser
- Kropsdysmorfe lidelser
- Terapeutik
- Mind-body terapier
- Komplementære terapier
- Psykoterapi
- Adfærdsdiscipliner og aktiviteter
- Hypnose
- Autogen træning
Andre undersøgelses-id-numre
- STUDY00007433
Plan for individuelle deltagerdata (IPD)
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