Mental DisorderNCT06885489
The Effect of Acceptance and Commitment Therapy-Based Intervention
A study testing Acceptance and Commitment Therapy (ACT) based psychoeducation program in people with Mental Disorder and Depression Disorders, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Mental health is essential for students' emotional, cognitive, and social well-being. University life presents significant academic, social, and financial challenges, leading to increased stress, anxiety, and depression. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Mental Disorder, Depression Disorders, Stress
- What is being tested?
- Acceptance and Commitment Therapy (ACT) based psychoeducation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2025to 10 Mar 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- ust be currently enrolled as a full-time student at a university.
Who cannot join
- Individuals with significant cognitive impairments or those unable to understand the study procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Acceptance and Commitment Therapy-Based Intervention on Depression, Anxiety, Stress and Psychological Well-Being Levels in University Students
Mental health is essential for students' emotional, cognitive, and social well-being. University life presents significant academic, social, and financial challenges, leading to increased stress, anxiety, and depression. These psychological difficulties negatively impact students' academic performance, relationships, and overall quality of life. Despite these challenges, many students avoid seeking professional help.
Acceptance and Commitment Therapy (ACT) is an effective approach that enhances psychological resilience and helps individuals cope with stress, anxiety, and depression. Instead of changing negative thoughts, ACT fosters psychological flexibility, encouraging individuals to develop a healthier relationship with them. Research supports ACT's effectiveness in reducing psychological distress, improving emotional regulation, and enhancing life satisfaction
- Conditions
- Mental Disorder, Depression Disorders, Stress, Anxiety, Acceptance and Commitment Therapy, Psychological Well-being
- Being tested
- Acceptance and Commitment Therapy (ACT) based psychoeducation program
- Medical subject headings
- Mental Disorders, Anxiety Disorders, 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 psychoeducation programBehavioural
This study implements an ACT-based psychological intervention designed to enhance psychological well-being and reduce depression, anxiety, and stress among university students. The intervention consists of structured sessions focusing on psychological flexibility, mindfulness, acceptance, and value-driven actions. Participants engage in experiential exercises, cognitive defusion techniques, and behavioral commitment strategies. The intervention is delivered over 8 weeks, with weekly sessions lasting approximately 40 minutes. The sessions are conducted in groups by trained professionals.
| Study group | Role | What they receive |
|---|---|---|
| ACT Intervention Group | Experimental | The group receiving Acceptance and Commitment Therapy (ACT)-based intervention. Receives: Behavioral: Acceptance and Commitment Therapy (ACT) based psychoeducation program |
| Control Group | No intervention | No intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression, Anxiety and Stress Scale (DASS-21)
DASS-21 is the short version of the Depression, Anxiety and Stress Scale-42 (DASS-42) developed by Lovibond and Lovibond. The Turkish adaptation of the scale was made by Sarıçam. The 4-point Likert-type scale includes a total of 21 items consisting of three sub-dimensions: depression, anxiety and stress. In the normal sample, test-retest reliability coefficients were found to be r=0.68 for depression, r=0.66 for anxiety and r=0.61 for stress. An individual's score of 5 and above on the depression sub-scale, 4 and above on the anxiety sub-scale and 8 and above on the stress sub-scale is interpreted as indicating the relevant psychological problem.
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start15 Jan 2025
- Primary completion28 Feb 2025
- Study completion10 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental DisorderStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ceylan Aksoy, Agri Ibrahim Cecen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06885489
- Sponsor's protocol ID
- E-95531838-050.99-124695
- Status last verified
- Mar 2025
- First submitted
- 12 Mar 2025
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acceptance and Commitment Therapy-Based Intervention on Depression, Anxiety, Stress and Psychological Well-Being Levels in University Students
- ClinicalTrials.gov ID
- NCT06885489
- Acronym / sponsor ID
- E-95531838-050.99-124695
- Conditions
- Mental Disorder, Depression Disorders, Stress, Anxiety, Acceptance and Commitment Therapy, Psychological Well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 10 Mar 2025 (actual)
- First posted
- 20 Mar 2025 (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.
Mental health is essential for students' emotional, cognitive, and social well-being. University life presents significant academic, social, and financial challenges, leading to increased stress, anxiety, and depression. These psychological difficulties negatively impact students' academic performance, relationships, and overall quality of life. Despite these challenges, many students avoid seeking professional help.
Acceptance and Commitment Therapy (ACT) is an effective approach that enhances psychological resilience and helps individuals cope with stress, anxiety, and depression. Instead of changing negative thoughts, ACT fosters psychological flexibility, encouraging individuals to develop a healthier relationship with them. Research supports ACT's effectiveness in reducing psychological distress, improving emotional regulation, and enhancing life satisfaction
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACT Intervention Group | Experimental | Behavioral: Acceptance and Commitment Therapy (ACT) based psychoeducation programThe group receiving Acceptance and Commitment Therapy (ACT)-based intervention. |
| Control Group | No intervention | –No intervention group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- ust be currently enrolled as a full-time student at a university.
Key exclusion criteria (1 listed)
- Individuals with significant cognitive impairments or those unable to understand the study procedures.
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 psychoeducation programThis study implements an ACT-based psychological intervention designed to enhance psychological well-being and reduce depression, anxiety, and stress among university students. The intervention consists of structured sessions focusing on psychological flexibility, mindfulness, acceptance, and value-driven actions. Participants engage in experiential exercises, cognitive defusion techniques, and behavioral commitment strategies. The intervention is delivered over 8 weeks, with weekly sessions lasting approximately 40 minutes. The sessions are conducted in groups by trained professionals. | Behavioural | ACT Intervention Group |
Primary outcome
Depression, Anxiety and Stress Scale (DASS-21)
Time frame: 8 week
DASS-21 is the short version of the Depression, Anxiety and Stress Scale-42 (DASS-42) developed by Lovibond and Lovibond. The Turkish adaptation of the scale was made by Sarıçam. The 4-point Likert-type scale includes a total of 21 items consisting of three sub-dimensions: depression, anxiety and stress. In the normal sample, test-retest reliability coefficients were found to be r=0.68 for depression, r=0.66 for anxiety and r=0.61 for stress. An individual's score of 5 and above on the depression sub-scale, 4 and above on the anxiety sub-scale and 8 and above on the stress sub-scale is interpreted as indicating the relevant psychological problem.
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 20 Mar 2025.
- Individual participant dataSharing planned: No
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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 psychoeducation program in people with Mental Disorder and Depression Disorders, run by Ataturk University at 1 site in Turkey (Türkiye).
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 1 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 20 Mar 2025. 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 Turkey (Türkiye). 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?
Depression, Anxiety and Stress Scale (DASS-21) (time frame: 8 week). 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 20 Mar 2025.