Depression - Major Depressive DisorderTIDAL-ACTNCT07442253
Tidal Model-Based ACT for Depression
A study testing Tidal Model-based ACT in people with Depression - Major Depressive Disorder, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this randomized controlled clinical trial is to evaluate the effectiveness of an Acceptance and Commitment Therapy (ACT)-oriented psychoeducation program based on the Tidal Model in patients diagnosed with depression who are receiving transcranial magnetic stimulation (TMS) treatment at a university… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression - Major Depressive Disorder
- What is being tested?
- Tidal Model-based ACT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Feb 2026to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years
- Receiving treatment for depression for at least 6 months
- Within the 6-month period following TMS treatment
- Able to communicate in Turkish without difficulty
- No hearing problems, cognitive impairments, or additional psychiatric disorders
- Willing to participate and has provided written informed consent
Who cannot join
- Participant withdraws voluntarily from the study
- Relapse of depression during the study period requiring psychiatric hospitalization
- Sİtuation in which participants do not attend two consecutive sessions
- Starting participants on other psychotropic medications (e.g., ANTIPSYCHOTIC, MOOD STABILIZER, etc.) IN ADDITION TO THEIR ongoing antidepressant or anxiolytic treatments, and additional psychotherapies other than the ACT intervention.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Gazi University Health Research and Application Center, Gazi Hospital
Ankara, 06790
Yeliz ARSLAN, PhD CANDİDATE, +90 5063895426, ylz26@hotmail.com
Ebru Akgün Çıtak, Professor, +90 312 246 66 66 ext. 6675, citak@baskent.edu.tr
About this study
Official title: THE EFFECT OF ACCEPTANCE AND STABİLİTY BASED PSYCHOEDUCATİON ON MEANİNG OF LİFE AND CONSCİOUS SELF-CARE İN PATİENTS WİTH DEPRESSİON BASED ON TİDAL MODEL
The purpose of this randomized controlled clinical trial is to evaluate the effectiveness of an Acceptance and Commitment Therapy (ACT)-oriented psychoeducation program based on the Tidal Model in patients diagnosed with depression who are receiving transcranial magnetic stimulation (TMS) treatment at a university hospital psychiatry clinic.
The primary objective of this study is to determine whether participation in the psychoeducation program improves meaning in life and conscious self-care compared to usual treatment alone. The main questions this study aims to answer are:
Read more
- Does the ACT-oriented psychoeducation program increase participants' level of meaning in life?
- Does the program improve conscious self-care behaviors in individuals with depression?
Participants will be randomly assigned to either an intervention group or a control group. The intervention group will receive an 8-week structured psychoeducation program in addition to standard TMS treatment. The control group will continue to receive standard treatment without additional psychoeducation.
Participants in the intervention group will attend weekly psychoeducation sessions focusing on psychological flexibility, values clarification, coping strategies, and self-care practices. Outcome measures will be collected at baseline, immediately after the intervention, and one month after completion of the program.
Read the detailed description
Depression is a chronic mental health condition that affects emotional regulation, motivation, and functional capacity. Even with pharmacological treatment and advanced interventions such as transcranial magnetic stimulation (TMS), many individuals continue to experience residual symptoms, including diminished sense of meaning in life, cognitive-emotional avoidance, and reduced self-care behaviors. These residual symptoms may contribute to prolonged recovery and relapse.
Meaning in life has been identified as an important psychological protective factor in recovery from depression. Individuals with a weaker sense of meaning may experience more severe or persistent depressive symptoms. Interventions targeting psychological flexibility, values clarification, and behavioral activation may support long-term recovery.
Acceptance and Commitment Therapy (ACT) offers a comprehensive approach that addresses both existential meaning and behavioral self-care processes. In addition, the Tidal Model, a nursing-based recovery framework, emphasizes person-centered care and individual narratives in mental health treatment.
This randomized controlled trial will be conducted in the psychiatry clinic of a university hospital. Patients receiving TMS treatment for depression will be randomly assigned to either the intervention group or the control group. The intervention group will participate in an 8-week ACT-oriented psychoeducation program based on the Tidal Model, while the control group will continue to receive standard treatment.
Outcome measures will be collected at three time points: baseline (pre-intervention), immediately after the intervention (post-test), and one month after completion (follow-up). The primary objective is to evaluate the effect of the psychoeducation program on meaning in life and conscious self-care.
The findings are expected to contribute to the development of structured nursing-based psychosocial interventions for individuals with treatment-resistant depression.
- Conditions
- Depression - Major Depressive Disorder
- Being tested
- Tidal Model-based ACT
- Keywords
- Acceptance and Commitment Therapy, Tidal Model Meaning in Life Conscious Self-Care, Nursing Intervention, Randomized Controlled Trial, depression, Transcranial Magnetic Stimulation
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tidal Model-based ACTBehavioural
This intervention combines standard Transcranial Magnetic Stimulation (TMS) treatment with an 8-session Acceptance and Commitment Therapy (ACT)-based psychoeducation program structured specifically within the Tidal Model framework. Unlike standard ACT or TMS interventions alone, this program integrates mindfulness, value-based actions, and experiential exercises tailored for patients with depression receiving TMS, aiming to enhance meaning in life and conscious self-care.
| Study group | Role | What they receive |
|---|---|---|
| Control group receiving standard treatment (n=23) | No intervention | Participants receive standard Transcranial Magnetic Stimulation (TMS) treatment only, without additional psychoeducation or behavioral intervention. |
| Experimental group receiving ACT based on Tidal Model (n=23) | Experimental | Participants in the experimental group receive 8-session Acceptance and Commitment Therapy (ACT)-based psychoeducation, structured within the Tidal Model, in addition to standard Transcranial Magnetic Stimulation (TMS) treatment. The program is designed to enhance meaning in life and conscious self-care. Total participants: 23. Receives: Behavioral: Tidal Model-based ACT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Meaning in Life
Measured using the Meaning in Life Questionnaire (MLQ) to assess changes in participants' perceived meaning and purpose in life.
Measured: Baseline (pre-intervention) to immediately post-intervention (8 weeks), and 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start26 Feb 2026 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression - Major Depressive 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention is an Acceptance and Commitment Therapy (ACT)-based psychoeducation program, structured within the framework of the Tidal Model.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YELIZ ARSLAN, Baskent University
- Investigators
- Ebru Akgün Çıtak, Professor, Principal investigator, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07442253
- Sponsor's protocol ID
- TIDALACT-PhD-2026
- Acronym
- TIDAL-ACT
- Status last verified
- Feb 2026
- First submitted
- 24 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual patient data will not be shared to protect participant privacy and confidentiality. Only aggregated, anonymized results will be published.
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF ACCEPTANCE AND STABİLİTY BASED PSYCHOEDUCATİON ON MEANİNG OF LİFE AND CONSCİOUS SELF-CARE İN PATİENTS WİTH DEPRESSİON BASED ON TİDAL MODEL
- ClinicalTrials.gov ID
- NCT07442253
- Acronym / sponsor ID
- TIDAL-ACT / TIDALACT-PhD-2026
- Conditions
- Depression - Major Depressive Disorder
- Keywords
- Acceptance and Commitment Therapy, Tidal Model Meaning in Life Conscious Self-Care, Nursing Intervention, Randomized Controlled Trial, depression, Transcranial Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 26 Feb 2026 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 2 Mar 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 purpose of this randomized controlled clinical trial is to evaluate the effectiveness of an Acceptance and Commitment Therapy (ACT)-oriented psychoeducation program based on the Tidal Model in patients diagnosed with depression who are receiving transcranial magnetic stimulation (TMS) treatment at a university hospital psychiatry clinic.
The primary objective of this study is to determine whether participation in the psychoeducation program improves meaning in life and conscious self-care compared to usual treatment alone. The main questions this study aims to answer are:
- Does the ACT-oriented psychoeducation program increase participants' level of meaning in life?
- Does the program improve conscious self-care behaviors in individuals with depression?
Participants will be randomly assigned to either an intervention group or a control group. The intervention group will receive an 8-week structured psychoeducation program in addition to standard TMS treatment. The control group will continue to receive standard treatment without additional psychoeducation.
Participants in the intervention group will attend weekly psychoeducation sessions focusing on psychological flexibility, values clarification, coping strategies, and self-care practices. Outcome measures will be collected at baseline, immediately after the intervention, and one month after completion of the program.
Detailed description
Depression is a chronic mental health condition that affects emotional regulation, motivation, and functional capacity. Even with pharmacological treatment and advanced interventions such as transcranial magnetic stimulation (TMS), many individuals continue to experience residual symptoms, including diminished sense of meaning in life, cognitive-emotional avoidance, and reduced self-care behaviors. These residual symptoms may contribute to prolonged recovery and relapse.
Meaning in life has been identified as an important psychological protective factor in recovery from depression. Individuals with a weaker sense of meaning may experience more severe or persistent depressive symptoms. Interventions targeting psychological flexibility, values clarification, and behavioral activation may support long-term recovery.
Acceptance and Commitment Therapy (ACT) offers a comprehensive approach that addresses both existential meaning and behavioral self-care processes. In addition, the Tidal Model, a nursing-based recovery framework, emphasizes person-centered care and individual narratives in mental health treatment.
This randomized controlled trial will be conducted in the psychiatry clinic of a university hospital. Patients receiving TMS treatment for depression will be randomly assigned to either the intervention group or the control group. The intervention group will participate in an 8-week ACT-oriented psychoeducation program based on the Tidal Model, while the control group will continue to receive standard treatment.
Outcome measures will be collected at three time points: baseline (pre-intervention), immediately after the intervention (post-test), and one month after completion (follow-up). The primary objective is to evaluate the effect of the psychoeducation program on meaning in life and conscious self-care.
The findings are expected to contribute to the development of structured nursing-based psychosocial interventions for individuals with treatment-resistant depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The intervention is an Acceptance and Commitment Therapy (ACT)-based psychoeducation program, structured within the framework of the Tidal Model.
| Arm | Type | Receives |
|---|---|---|
| Control group receiving standard treatment (n=23) | No intervention | –Participants receive standard Transcranial Magnetic Stimulation (TMS) treatment only, without additional psychoeducation or behavioral intervention. |
| Experimental group receiving ACT based on Tidal Model (n=23) | Experimental | Behavioral: Tidal Model-based ACTParticipants in the experimental group receive 8-session Acceptance and Commitment Therapy (ACT)-based psychoeducation, structured within the Tidal Model, in addition to standard Transcranial Magnetic Stimulation (TMS) treatment. The program is designed to enhance meaning in life and conscious self-care. Total participants: 23. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18 and 65 years
- Receiving treatment for depression for at least 6 months
- Within the 6-month period following TMS treatment
- Able to communicate in Turkish without difficulty
- No hearing problems, cognitive impairments, or additional psychiatric disorders
Key exclusion criteria (4 listed)
- Participant withdraws voluntarily from the study
- Relapse of depression during the study period requiring psychiatric hospitalization
- Sİtuation in which participants do not attend two consecutive sessions
- Starting participants on other psychotropic medications (e.g., ANTIPSYCHOTIC, MOOD STABILIZER, etc.) IN ADDITION TO THEIR ongoing antidepressant or anxiolytic treatments, and additional psychotherapies other than the ACT intervention.
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 |
|---|---|---|
| Tidal Model-based ACTThis intervention combines standard Transcranial Magnetic Stimulation (TMS) treatment with an 8-session Acceptance and Commitment Therapy (ACT)-based psychoeducation program structured specifically within the Tidal Model framework. Unlike standard ACT or TMS interventions alone, this program integrates mindfulness, value-based actions, and experiential exercises tailored for patients with depression receiving TMS, aiming to enhance meaning in life and conscious self-care. | Behavioural | Experimental group receiving ACT based on Tidal Model (n=23) |
Primary outcome
Meaning in Life
Time frame: Baseline (pre-intervention) to immediately post-intervention (8 weeks), and 1-month follow-up
Measured using the Meaning in Life Questionnaire (MLQ) to assess changes in participants' perceived meaning and purpose in life.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Individual participant dataSharing planned: No. Individual patient data will not be shared to protect participant privacy and confidentiality. Only aggregated, anonymized results will be published.
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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.
Ebru Akgün Çıtak, Professor principal investigator
Baskent University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tidal Model-based ACT in people with Depression - Major Depressive Disorder, run by Baskent 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 6 inclusion and 4 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: opening soon, as of the sponsor's last update on 2 Mar 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yeliz ARSLAN, PhD Candidate (+90 5063895426, ylz26@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Meaning in Life (time frame: Baseline (pre-intervention) to immediately post-intervention (8 weeks), and 1-month follow-up). 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 Mar 2026.