NCT07620483

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 2, 2026

Completed
Last Updated

June 2, 2026

Status Verified

May 1, 2026

Enrollment Period

3 months

First QC Date

May 12, 2026

Last Update Submit

May 26, 2026

Conditions

Keywords

Acceptance and Commitment TherapyPsychological FlexibilitySingle-Case Experimental DesignBrief Psychological InterventionMental Health

Outcome Measures

Primary Outcomes (3)

  • Mindful Attention Awareness Scale (MAAS)

    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)

    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)

    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.

Secondary Outcomes (3)

  • Valuing Questionnaire - Obstruction Subscale (VQ-Obstruction)

    Weekly during baseline (4 weeks), intervention (6 weeks), and follow-up (3 weeks), up to 13 weeks.

  • Satisfaction With Life Scale (SWLS)

    Weekly during baseline (4 weeks), intervention (6 weeks), and follow-up (3 weeks), up to 13 weeks.

  • Flourishing Scale (FS)

    Weekly during baseline (4 weeks), intervention (6 weeks), and follow-up (3 weeks), up to 13 weeks.

Study Arms (1)

ACT-Based Brief Group Intervention

EXPERIMENTAL

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.

Behavioral: Acceptance and Commitment Therapy (ACT)-Based Brief Group Intervention

Interventions

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

Also known as: ACT Brief, ACT Protocol Group, ACT Intervention
ACT-Based Brief Group Intervention

Eligibility Criteria

Age18 Years - 28 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Psychology, Universidad del Valle

Cali, Valle del Cauca Department, 760032, Colombia

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
This was an open-label single-case experimental study. Participants, intervention providers, and investigators were aware of the intervention procedures, and no masking procedures were implemented.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: The study employed a Single-Case Experimental Design (SCED) with repeated longitudinal measurements across three phases: baseline, intervention, and follow-up. Participants completed thirteen repeated assessments distributed across the study phases. The intervention consisted of five weekly ACT-based group sessions focused on psychological flexibility processes.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2026

First Posted

June 2, 2026

Study Start

April 1, 2025

Primary Completion

June 15, 2025

Study Completion

June 30, 2025

Last Updated

June 2, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations