NCT07442253

Brief 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 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 Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
0mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress91%
Feb 2026Jun 2026

First Submitted

Initial submission to the registry

February 24, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

February 26, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 2, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

2 months

First QC Date

February 24, 2026

Last Update Submit

February 24, 2026

Conditions

Keywords

Acceptance and Commitment TherapyTidal Model Meaning in Life Conscious Self-CareNursing InterventionRandomized Controlled TrialdepressionTranscranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (1)

  • Meaning in Life

    Measured using the Meaning in Life Questionnaire (MLQ) to assess changes in participants' perceived meaning and purpose in life.

    Baseline (pre-intervention) to immediately post-intervention (8 weeks), and 1-month follow-up

Study Arms (2)

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.

Behavioral: Tidal Model-based ACT

Interventions

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.

Experimental group receiving ACT based on Tidal Model (n=23)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University Health Research and Application Center, Gazi Hospital

Ankara, 06790, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Ebru Akgün Çıtak, Professor

    Baskent University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yeliz ARSLAN, PhD Candidate

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The intervention is an Acceptance and Commitment Therapy (ACT)-based psychoeducation program, structured within the framework of the Tidal Model.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

February 24, 2026

First Posted

March 2, 2026

Study Start

February 26, 2026

Primary Completion

May 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

March 2, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Individual patient data will not be shared to protect participant privacy and confidentiality. Only aggregated, anonymized results will be published.

Locations