Gazi University Health Research and Application Center, Gazi Hospital
Ankara, 06790, Turkey (Türkiye)
NCT Number: NCT07442253
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.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Not applicable
Ankara, 06790, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Baskent University
Other
THE EFFECT OF ACCEPTANCE AND STABİLİTY BASED PSYCHOEDUCATİON ON MEANİNG OF LİFE AND CONSCİOUS SELF-CARE İN PATİENTS WİTH DEPRESSİON BASED ON TİDAL MODEL
Acronym: TIDAL-ACT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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