DepressionNCT06022497
Tidal Model's Effects on Emotion Regulation and Recovery
A study testing Tidal Model Based Emotion Regulation Interventions in people with Depression, run by Izmir Katip Celebi University at 2 sites in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effectiveness of Tidal Model-based emotion regulation interventions on recovery in individuals diagnosed with depression and nursing diagnosis of impaired mood regulation. The research was designed as a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Depression
- What is being tested?
- Tidal Model Based Emotion Regulation Interventions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 23 Jun 2023
- 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 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of moderate Depression according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-V criteria
- Having a nursing diagnosis of Impaired Mood Regulation
- Psychiatrist prescribing serotonin reuptake inhibitor (SSRI)
- Man or Women aged 25-55
- Being followed by the psychiatry outpatient clinic
- Able to provide written informed consent
Who cannot join
- Presence of an additional mental illness
- Diagnosis of severe Depression according to DSM-V criteria
- Presence of suicidal attempts or thoughts
- Presence of another physical illness that affects cognition
- Have received any kind of therapy in the last six months
- Voluntary involvement in another study at the same time
- Inability to read and write
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Ege University
Izmir, Bornova, 35100
Izmir Katip Celebi University
Izmir, Cigli, 35620
About this study
Official title: The Effect of Tidal Model-Based Emotion Regulation Nursing Interventions on Recovery in Individuals Diagnosed With Nursing Diagnosis of Impaired Mood Regulation
The aim of this study is to investigate the effectiveness of Tidal Model-based emotion regulation interventions on recovery in individuals diagnosed with depression and nursing diagnosis of impaired mood regulation. The research was designed as a randomized controlled trial.
The main hypothesis; After nursing interventions for emotion regulation based on the Tidal Model, there is a significant difference between the recovery, difficulty in emotion regulation, depression levels and nursing outcome criteria of individuals in the intervention and control groups.
Read the detailed description
The research carried out with patients followed in psychiatry outpatient clinics. As a result of the G-power analysis, the sample consisted of 23 interventions and 23 control groups. In the study, while the control group received only routine treatment, in the intervention group, Tidal Model-based nursing interventions were applied in addition to the routine treatment. Pre-tests administered before individuals were randomly assigned to the intervention and control groups. Randomization was created using the website randomizer.org. After this randomization was created, it was hidden from the physician who made the diagnosis of depression and from the researcher who conducted the interviews (allocation concealment). After the pre-tests were completed, the researcher (consulting faculty member) who knew the random assignment order was reached and the individuals were randomly assigned to the control or intervention group. Tidal Model-based nursing interventions were structured as 8 sessions in total. Each individual in the intervention group participated in a session for a total of 8 weeks, one session per week. In the eighth session, post-tests were applied to the individuals in the intervention group. Individuals in the control group were asked to come back 8 weeks after the first interviews and post-tests were applied. All interviews were conducted face to face. Recovery Assessment Scale (RAS), Difficulties in Emotion Regulation Scale (DERS), and Nursing Outcomes Criteria (NOC) were used.
- Conditions
- Depression
- Being tested
- Tidal Model Based Emotion Regulation Interventions
- Keywords
- Emotional Regulation, Psychiatric Nursing, Tidal Model, Recovery
- Medical subject headings
- Depression, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tidal Model Based Emotion Regulation InterventionsOther
The Tidal Model is a nursing model and was developed by Phil Barker. It is an important model for psychiatric nursing care. In the research, nursing interventions for emotion regulation were structured by using the Tidal Model.At each session, emotion regulation interventions were applied within the Tidal Model care domains.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | In the intervention group, Tidal Model-based emotion regulation nursing interventions were applied in addition to the routine treatment. Tidal Model-based emotion regulation nursing interventions were structured as eight sessions in total. Each individual in the intervention group participated in a session for a total of 8 weeks, one session per week. All interviews were conducted face to face. Receives: Other: Tidal Model Based Emotion Regulation Interventions |
| Control Group | No intervention | The control group received only routine treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery Assesment Scale
Recovery Assesment Scale was developed by Corrigan et al. (2004), and adapted to Turkish by Guler and Gurkan (2017) who also carried out the validity and reliability. It consist of 24 items, 5 point likert type. A high total score from the scale indicates a high level of improvement.Scale has five factors: personal confidence and hope, willingness to ask for help, goal and success orientation, reliance on others, and no domination by symptoms
Measured: before and end of the interventions (eight weeks)
Difficulties in Emotion Regulation
Difficulties in Emotion Regulation was developed by Gratz and Roemer (2004), and adapted to Turkish by Rugancı and Gencoz (2010) who also carried out the validity and reliability. It consist of 36 items, 5 point likert type. A high score on the scale indicates difficulty in emotion regulation. Scale has six factors: Awareness, Clarity, Impulse, Goals, Non-acceptance, Strategies.
Measured: before and end of the interventions (eight weeks)
Hamilton Depression Rating Scale
Hamilton Depression Rating Scale was developed Hamilton et al. (1960), and adapted to Turkish by Akdemir et al. (1997) who also carried out the validity and reliability. The highest 51 points can be obtained from the scale.A score of less than 7 indicates that there is no depression, 8 to 15 points of mild depression, 16-28 points of moderate level, and 29 points and above indicate severe depression.
Measured: before and end of the interventions (eight weeks)
Secondary outcomes (1)
Nursing Outcome Criteria
Nursing Outcome Criteria is used to evaluate the patient's condition and is scored on a five-point Likert scale.
Measured: before and end of the interventions (eight weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start1 Apr 2022
- Primary completion5 May 2023
- Study completion23 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Collaborators
- Ege University
- Responsible party
- Principal investigator, Gulsenay TAS SOYLU, Izmir Katip Celebi University
- Investigators
- Mahire Olcay Çam, Prof. Dr., Study director, Ege University, Faculty of Nursing, Department of Pschiatric NursingGulsenay TAS SOYLU, Principal investigator, Izmir KAtip Celebi University, Faculty of Health Sciences, Department of Pschiatric Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06022497
- Sponsor's protocol ID
- IRB Number: 21-11T/23
- Status last verified
- Sep 2023
- First submitted
- 28 Aug 2023
- Last updated
- 8 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tas Soylu G, Cam MO, Zorlu N. The effect of tidal model-based emotion regulation nursing interventions on recovery in individuals with depression: A randomized controlled trial. Arch Psychiatr Nurs. 2026 Feb;60:152028. doi: 10.1016/j.apnu.2025.152028. Epub 2025 Dec 2.
PubMed 41864702
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Tidal Model-Based Emotion Regulation Nursing Interventions on Recovery in Individuals Diagnosed With Nursing Diagnosis of Impaired Mood Regulation
- ClinicalTrials.gov ID
- NCT06022497
- Acronym / sponsor ID
- IRB Number: 21-11T/23
- Conditions
- Depression
- Keywords
- Emotional Regulation, Psychiatric Nursing, Tidal Model, Recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Collaborators
- Ege University
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 5 May 2023 (actual)
- Study completion
- 23 Jun 2023 (actual)
- First posted
- 5 Sep 2023 (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 aim of this study is to investigate the effectiveness of Tidal Model-based emotion regulation interventions on recovery in individuals diagnosed with depression and nursing diagnosis of impaired mood regulation. The research was designed as a randomized controlled trial.
The main hypothesis; After nursing interventions for emotion regulation based on the Tidal Model, there is a significant difference between the recovery, difficulty in emotion regulation, depression levels and nursing outcome criteria of individuals in the intervention and control groups.
Detailed description
The research carried out with patients followed in psychiatry outpatient clinics. As a result of the G-power analysis, the sample consisted of 23 interventions and 23 control groups. In the study, while the control group received only routine treatment, in the intervention group, Tidal Model-based nursing interventions were applied in addition to the routine treatment. Pre-tests administered before individuals were randomly assigned to the intervention and control groups. Randomization was created using the website randomizer.org. After this randomization was created, it was hidden from the physician who made the diagnosis of depression and from the researcher who conducted the interviews (allocation concealment). After the pre-tests were completed, the researcher (consulting faculty member) who knew the random assignment order was reached and the individuals were randomly assigned to the control or intervention group. Tidal Model-based nursing interventions were structured as 8 sessions in total. Each individual in the intervention group participated in a session for a total of 8 weeks, one session per week. In the eighth session, post-tests were applied to the individuals in the intervention group. Individuals in the control group were asked to come back 8 weeks after the first interviews and post-tests were applied. All interviews were conducted face to face. Recovery Assessment Scale (RAS), Difficulties in Emotion Regulation Scale (DERS), and Nursing Outcomes Criteria (NOC) were used.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Tidal Model Based Emotion Regulation InterventionsIn the intervention group, Tidal Model-based emotion regulation nursing interventions were applied in addition to the routine treatment. Tidal Model-based emotion regulation nursing interventions were structured as eight sessions in total. Each individual in the intervention group participated in a session for a total of 8 weeks, one session per week. All interviews were conducted face to face. |
| Control Group | No intervention | –The control group received only routine treatment. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Diagnosis of moderate Depression according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-V criteria
- Having a nursing diagnosis of Impaired Mood Regulation
- Psychiatrist prescribing serotonin reuptake inhibitor (SSRI)
- Man or Women aged 25-55
- Being followed by the psychiatry outpatient clinic
Key exclusion criteria (7 listed)
- Presence of an additional mental illness
- Diagnosis of severe Depression according to DSM-V criteria
- Presence of suicidal attempts or thoughts
- Presence of another physical illness that affects cognition
- Have received any kind of therapy in the last six months
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 Emotion Regulation InterventionsThe Tidal Model is a nursing model and was developed by Phil Barker. It is an important model for psychiatric nursing care. In the research, nursing interventions for emotion regulation were structured by using the Tidal Model.At each session, emotion regulation interventions were applied within the Tidal Model care domains. | Other | Intervention Group |
Primary outcome
Recovery Assesment Scale
Time frame: before and end of the interventions (eight weeks)
Recovery Assesment Scale was developed by Corrigan et al. (2004), and adapted to Turkish by Guler and Gurkan (2017) who also carried out the validity and reliability. It consist of 24 items, 5 point likert type. A high total score from the scale indicates a high level of improvement.Scale has five factors: personal confidence and hope, willingness to ask for help, goal and success orientation, reliance on others, and no domination by symptoms
Difficulties in Emotion Regulation
Time frame: before and end of the interventions (eight weeks)
Difficulties in Emotion Regulation was developed by Gratz and Roemer (2004), and adapted to Turkish by Rugancı and Gencoz (2010) who also carried out the validity and reliability. It consist of 36 items, 5 point likert type. A high score on the scale indicates difficulty in emotion regulation. Scale has six factors: Awareness, Clarity, Impulse, Goals, Non-acceptance, Strategies.
Hamilton Depression Rating Scale
Time frame: before and end of the interventions (eight weeks)
Hamilton Depression Rating Scale was developed Hamilton et al. (1960), and adapted to Turkish by Akdemir et al. (1997) who also carried out the validity and reliability. The highest 51 points can be obtained from the scale.A score of less than 7 indicates that there is no depression, 8 to 15 points of mild depression, 16-28 points of moderate level, and 29 points and above indicate severe depression.
1 secondary outcome
Nursing Outcome Criteria
Time frame: before and end of the interventions (eight weeks)
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 8 Sep 2023.
- Derived from this study: PubMed 41864702Tas Soylu G, Cam MO, Zorlu N. The effect of tidal model-based emotion regulation nursing interventions on recovery in individuals with depression: A randomized controlled trial. Arch Psychiatr Nurs. 2026 Feb;60:152028. doi: 10.1016/j.apnu.2025.152028. Epub 2025 Dec 2.
- 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.
Mahire Olcay Çam, Prof. Dr. study director
Ege University, Faculty of Nursing, Department of Pschiatric Nursing
Gulsenay TAS SOYLU principal investigator
Izmir KAtip Celebi University, Faculty of Health Sciences, Department of Pschiatric Nursing
2 sites 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 Emotion Regulation Interventions in people with Depression, run by Izmir Katip Celebi University at 2 sites 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 7 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 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Recovery Assesment Scale (time frame: before and end of the interventions (eight weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06022497, which also lists 1 linked publication.
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 8 Sep 2023.