Psychological FlexibilityACT-UNIVALLENCT07620483
Acceptance and Commitment Therapy on Psychological Flexibility, Values, and Well-Being: A Single-Case Experimental Study
A study testing Acceptance and Commitment Therapy (ACT)-Based Brief Group Intervention in people with Psychological Flexibility and Emotional Distress, run by Universidad del Valle, Colombia at 1 site in Colombia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological Flexibility, Emotional Distress, Psychological Well-Being
- What is being tested?
- Acceptance and Commitment Therapy (ACT)-Based Brief Group Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteColombia
- Study dates
- 1 Apr 2025to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 28 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Faculty of Psychology, Universidad del Valle
Cali, Valle del Cauca Department, 760032
About this study
Official title: 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:
Read more
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.
Read the detailed description
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.
- Conditions
- Psychological Flexibility, Emotional Distress, Psychological Well-Being, Experiential Avoidance, Cognitive Fusion
- Being tested
- Acceptance and Commitment Therapy (ACT)-Based Brief Group Intervention
- Keywords
- Acceptance and Commitment Therapy, Psychological Flexibility, Single-Case Experimental Design, Brief Psychological Intervention, Mental Health
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment Therapy (ACT)-Based Brief Group InterventionBehavioural
Also called ACT Brief, ACT Protocol Group, ACT Intervention
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Acceptance and Commitment Therapy (ACT)-Based Brief Group Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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)
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.
Measured: Weekly during baseline (4 weeks), intervention (6 weeks), and follow-up (3 weeks), up to 13 weeks.
Satisfaction With Life Scale (SWLS)
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.
Measured: Weekly during baseline (4 weeks), intervention (6 weeks), and follow-up (3 weeks), up to 13 weeks.
Flourishing Scale (FS)
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.
Measured: Weekly during baseline (4 weeks), intervention (6 weeks), and follow-up (3 weeks), up to 13 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start1 Apr 2025
- Primary completion15 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological FlexibilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad del Valle, Colombia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07620483
- Sponsor's protocol ID
- Universidad del Valle
- Other IDs
- UNIVALLE-ACT-2025, Faculty of Psychology
- Acronym
- ACT-UNIVALLE
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptance and Commitment Therapy on Psychological Flexibility, Values, and Well-Being
- ClinicalTrials.gov ID
- NCT07620483
- Acronym / sponsor ID
- ACT-UNIVALLE / Universidad del Valle
- Conditions
- Psychological Flexibility, Emotional Distress, Psychological Well-Being, Experiential Avoidance, Cognitive Fusion
- Keywords
- Acceptance and Commitment Therapy, Psychological Flexibility, Single-Case Experimental Design, Brief Psychological Intervention, Mental Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Universidad del Valle, ColombiaUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| ACT-Based Brief Group Intervention | Experimental | Behavioral: Acceptance and Commitment Therapy (ACT)-Based Brief Group InterventionThe 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. |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- University students aged 18 years or older Interest in strengthening mental health and psychological well-being Voluntary agreement to participate in the study
- Depression Anxiety Stress Scales (DASS-21) General Health Questionnaire (GHQ-12) State Worry Questionnaire-11 (SWQ-11)
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and Commitment Therapy (ACT)-Based Brief Group InterventionAlso: ACT Brief, ACT Protocol Group, ACT InterventionThe 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 | Behavioural | ACT-Based Brief Group Intervention |
Primary outcome
Mindful Attention Awareness Scale (MAAS)
Time frame: 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.
Acceptance and Action Questionnaire-II (AAQ-II)
Time frame: 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.
Cognitive Fusion Questionnaire (CFQ)
Time frame: 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.
3 secondary outcomes
Valuing Questionnaire - Obstruction Subscale (VQ-Obstruction)
Time frame: Weekly during baseline (4 weeks), intervention (6 weeks), and follow-up (3 weeks), up to 13 weeks.
Satisfaction With Life Scale (SWLS)
Time frame: Weekly during baseline (4 weeks), intervention (6 weeks), and follow-up (3 weeks), up to 13 weeks.
Flourishing Scale (FS)
Time frame: Weekly during baseline (4 weeks), intervention (6 weeks), and follow-up (3 weeks), up to 13 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Psychological Flexibility
Active, not recruitingPhase 2
Novel and Conventional Interventions for Cognitive and Emotional Flexibility in Patient Trauma
Depression, Anxiety
Recruiting
FlexED: National Substudy
Eating Disorders, Body Image
Not yet recruiting
Mindfulness Training in University Badminton Athletes
Competitive Anxiety, Attentional Control
Recruiting
ACT for Dementia Caregivers: Evaluating Psychological Flexibility as the Mechanism to Improve Psychological Distress
Dementia Caregivers
Not yet recruiting
ACT-Based Counseling to Improve Psychological Flexibility in Mothers of Infants Hospitalized in the NICU
Psychological Flexibility, Psychological Distress
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy (ACT)-Based Brief Group Intervention in people with Psychological Flexibility and Emotional Distress, run by Universidad del Valle, Colombia at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mindful Attention Awareness Scale (MAAS) (time frame: Weekly during baseline (4 weeks), intervention (6 weeks), and follow-up (3 weeks), up to 13 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.