- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07620483
Acceptance and Commitment Therapy on Psychological Flexibility, Values, and Well-Being: A Single-Case Experimental Study (ACT-UNIVALLE)
Acceptance and Commitment Therapy on Psychological Flexibility, Values, and Well-Being
The goal of this clinical trial is to evaluate the effects of a brief Acceptance and Commitment Therapy (ACT)-based group intervention on psychological flexibility, values-based functioning, and psychological well-being in university students aged 18 to 28 years presenting elevated levels of emotional distress and psychological risk indicators.
The main questions it aims to answer are:
Does a brief ACT-based intervention reduce experiential avoidance and cognitive fusion in university students? Does the intervention improve present-moment awareness, values-based functioning, life satisfaction, and psychological flourishing?
Participants will:
Complete repeated self-report assessments across 13 measurement points distributed throughout baseline, intervention, and follow-up phases.
Participate in five weekly ACT-based group intervention sessions delivered by trained clinical psychologists.
Engage in experiential ACT exercises focused on acceptance, mindfulness, cognitive defusion, values clarification, and committed action.
Complete between-session activities and behavioral practices related to the ACT processes addressed during the intervention.
Participate in follow-up assessments to evaluate maintenance of treatment effects over time.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
University students frequently experience elevated levels of emotional distress, including symptoms of anxiety, depression, stress, worry, and psychological maladjustment. Brief interventions based on Acceptance and Commitment Therapy (ACT) have shown promising results in reducing experiential avoidance and cognitive fusion while promoting psychological flexibility and well-being.
The present study evaluates the effects of a brief ACT-based intervention protocol delivered in a group format using a Single-Case Experimental Design (SCED) with repeated measurements across baseline, intervention, and follow-up phases. The intervention focuses on core ACT processes, including acceptance, cognitive defusion, present-moment awareness, values clarification, and committed action.
Participants completed repeated assessments of psychological flexibility processes and well-being indicators across thirteen measurement points distributed throughout the study phases. The investigators hypothesize that the ACT-based intervention will produce reductions in experiential avoidance and cognitive fusion, together with improvements in present-moment awareness, values-based functioning, life satisfaction, and flourishing.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Valle del Cauca Department
-
Cali, Valle del Cauca Department, Colombia, 760032
- Faculty of Psychology, Universidad del Valle
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
University students aged 18 years or older Interest in strengthening mental health and psychological well-being Voluntary agreement to participate in the study
High-risk scores on at least one of the following screening instruments:
Depression Anxiety Stress Scales (DASS-21) General Health Questionnaire (GHQ-12) State Worry Questionnaire-11 (SWQ-11)
Exclusion Criteria:
Current psychological or psychiatric treatment Current use of psychiatric medication Diagnosis related to developmental or learning difficulties Failure to attend intervention sessions Incomplete participation in study assessments
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: ACT-Based Brief Group Intervention
The intervention consisted of a brief ACT-based group protocol delivered weekly by trained clinical psychologists.
The protocol targeted core ACT processes including acceptance, cognitive defusion, present-moment awareness, values clarification, and committed action.
Sessions incorporated experiential exercises, metaphors, mindfulness practices, reflective activities, and between-session behavioral tasks designed to promote psychological flexibility and psychological well-being in university students.
|
The intervention consisted of a brief group-based Acceptance and Commitment Therapy (ACT) protocol designed to promote psychological flexibility and psychological well-being in university students presenting elevated emotional distress and psychological risk indicators. The protocol was grounded in the functional contextual approach and targeted core ACT processes, including acceptance, cognitive defusion, present-moment awareness, values clarification, and committed action. Participants were organized into small groups of 5 to 8 individuals and attended five weekly intervention sessions conducted by trained clinical psychologists with at least five years of clinical experience. Prior to implementation, therapists completed specialized ACT training delivered by an expert clinician with extensive experience in Acceptance and Commitment Therapy. The intervention protocol included an initial preliminary session focused on motivational engagement, informed consent procedures, feedback rega
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Mindful Attention Awareness Scale (MAAS)
Tidsramme: Weekly during baseline (4 weeks), intervention (6 weeks), and follow-up (3 weeks), up to 13 weeks
|
The Mindful Attention Awareness Scale (MAAS) is a 15-item self-report questionnaire designed to assess present-moment attention and awareness in daily life.
Items are rated on a 6-point Likert-type scale ranging from 1 ("almost always") to 6 ("almost never").
Total scores are calculated by summing item responses, with higher scores indicating greater mindfulness and present-moment awareness.
|
Weekly during baseline (4 weeks), intervention (6 weeks), and follow-up (3 weeks), up to 13 weeks
|
|
Acceptance and Action Questionnaire-II (AAQ-II)
Tidsramme: Weekly during baseline (4 weeks), intervention (6 weeks), and follow-up (3 weeks), up to 13 weeks.
|
The Acceptance and Action Questionnaire-II (AAQ-II) is a 7-item self-report questionnaire designed to assess experiential avoidance and psychological inflexibility.
Items are rated on a 7-point Likert-type scale ranging from 1 ("never true") to 7 ("always true").
Total scores are calculated by summing item responses, with higher scores indicating greater experiential avoidance and psychological inflexibility.
|
Weekly during baseline (4 weeks), intervention (6 weeks), and follow-up (3 weeks), up to 13 weeks.
|
|
Cognitive Fusion Questionnaire (CFQ)
Tidsramme: Weekly during baseline (4 weeks), intervention (6 weeks), and follow-up (3 weeks), up to 13 weeks.
|
The Cognitive Fusion Questionnaire (CFQ) is a 7-item self-report questionnaire designed to assess cognitive fusion.
Items are rated on a 7-point Likert-type scale ranging from 1 ("never true") to 7 ("always true").
Total scores are calculated by summing item responses, with higher scores indicating greater cognitive fusion.
|
Weekly during baseline (4 weeks), intervention (6 weeks), and follow-up (3 weeks), up to 13 weeks.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Valuing Questionnaire - Obstruction Subscale (VQ-Obstruction)
Tidsramme: Weekly during baseline (4 weeks), intervention (6 weeks), and follow-up (3 weeks), up to 13 weeks.
|
The Valuing Questionnaire - Obstruction Subscale (VQ-Obstruction) is a 5-item self-report measure designed to assess barriers and interference with values-based living.
Items are rated on a 7-point Likert-type scale ranging from 0 ("not at all true") to 6 ("completely true").
Higher scores indicate greater obstruction in valued living.
|
Weekly during baseline (4 weeks), intervention (6 weeks), and follow-up (3 weeks), up to 13 weeks.
|
|
Satisfaction With Life Scale (SWLS)
Tidsramme: Weekly during baseline (4 weeks), intervention (6 weeks), and follow-up (3 weeks), up to 13 weeks.
|
The Satisfaction With Life Scale (SWLS) is a 5-item self-report questionnaire designed to assess global life satisfaction.
Items are rated on a 7-point Likert-type scale ranging from 1 ("strongly disagree") to 7 ("strongly agree").
Total scores are calculated by summing item responses, with higher scores indicating greater life satisfaction.
|
Weekly during baseline (4 weeks), intervention (6 weeks), and follow-up (3 weeks), up to 13 weeks.
|
|
Flourishing Scale (FS)
Tidsramme: Weekly during baseline (4 weeks), intervention (6 weeks), and follow-up (3 weeks), up to 13 weeks.
|
The Flourishing Scale (FS) is an 8-item self-report questionnaire designed to assess psychological flourishing, including meaning in life, interpersonal relationships, competence, and optimism.
Items are rated on a 7-point Likert-type scale ranging from 1 ("strongly disagree") to 7 ("strongly agree").
Total scores are calculated by summing item responses, with higher scores indicating greater psychological flourishing.
|
Weekly during baseline (4 weeks), intervention (6 weeks), and follow-up (3 weeks), up to 13 weeks.
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Universidad del Valle
- UNIVALLE-ACT-2025 (Anden identifikator: Faculty of Psychology, Universidad del Valle)
- Faculty of Psychology (Anden identifikator: Faculty of Psychology, Universidad del Valle)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Følelsesmæssig nød
-
Saglik Bilimleri UniversitesiAfsluttetAngst | Emotional Freedom TechniquesTyrkiet (Türkiye)
-
Kahramanmaras Sutcu Imam UniversityAfsluttetEffekten af Emotional Freedom Technique på angst, smerte og vitale tegnTyrkiet (Türkiye)
-
Massachusetts General HospitalAfsluttetAttention Deficit Hyperactivity Disorder (ADHD) | Deficient Emotional Self-Regulation (DESR)Forenede Stater
Kliniske forsøg med Acceptance and Commitment Therapy (ACT)-Based Brief Group Intervention
-
King's College Hospital NHS TrustKing's College London; Barts & The London NHS Trust; University Hospital... og andre samarbejdspartnereAfsluttet
-
Rikard WicksellRegion Stockholm; Skandia Insurance Company, Ltd.Afsluttet
-
National Cancer Institute (NCI)AfsluttetNeurofibromatose type 1 | Plexiforme neurofibromerForenede Stater
-
Southern Methodist UniversityAfsluttetAngst | Ikke-suicidal selvskadeForenede Stater
-
King's College LondonDiabetes UKUkendtDiabetes mellitus | Smertefuld diabetisk neuropatiDet Forenede Kongerige
-
Instituto de Investigación Marqués de ValdecillaRekrutteringMild kognitiv svækkelseSpanien
-
The Miriam HospitalAktiv, ikke rekrutterendeOvervægt og fedmeForenede Stater
-
The Hong Kong Polytechnic UniversityRekruttering
-
University of AlcalaHospital Universitario Principe de AsturiasAfsluttetPaniklidelse | Accept- og forpligtelsesterapi | Prædiktor | Kognitiv-adfærdsterapiSpanien
-
Region SkaneLund UniversityAktiv, ikke rekrutterendeAngst | Psykisk lidelse | Psykisk stress | Psykisk depression | Psykisk sundhedsproblem | Rumination - TankerSverige