- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07442253
Tidal Model-Based ACT for Depression (TIDAL-ACT)
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:
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yeliz ARSLAN, PhD CANDİDATE
- Phone Number: +90 5063895426
- Email: ylz26@hotmail.com
Study Locations
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Ankara, Turkey (Türkiye), 06790
- Gazi University Health Research and Application Center, Gazi Hospital
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Contact:
- Yeliz ARSLAN, PhD CANDİDATE
- Phone Number: +90 5063895426
- Email: ylz26@hotmail.com
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Contact:
- Ebru Akgün Çıtak, Professor
- Phone Number: 6675 +90 312 246 66 66
- Email: citak@baskent.edu.tr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control group receiving standard treatment (n=23)
Participants receive standard Transcranial Magnetic Stimulation (TMS) treatment only, without additional psychoeducation or behavioral intervention.
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Experimental: Experimental group receiving ACT based on Tidal Model (n=23)
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Meaning in Life
Time Frame: Baseline (pre-intervention) to immediately post-intervention (8 weeks), and 1-month follow-up
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Measured using the Meaning in Life Questionnaire (MLQ) to assess changes in participants' perceived meaning and purpose in life.
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Baseline (pre-intervention) to immediately post-intervention (8 weeks), and 1-month follow-up
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ebru Akgün Çıtak, Professor, Baskent University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TIDALACT-PhD-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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