Tidal Model's Effects on Emotion Regulation and Recovery

NCT ID: NCT06022497

Last Updated: 2023-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2023-06-23

Brief 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.

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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention Group

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.

Group Type: EXPERIMENTAL

Tidal Model Based Emotion Regulation Interventions

Intervention Type: OTHER

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.

Control Group

The control group received only routine treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Tidal Model Based Emotion Regulation Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ege University

OTHER

Sponsor Role: collaborator

Izmir Katip Celebi University

OTHER

Sponsor Role: lead

Responsible Party

Gulsenay TAS SOYLU

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mahire Olcay Çam, Prof. Dr.

Role: STUDY_DIRECTOR

Ege University, Faculty of Nursing, Department of Pschiatric Nursing

Gulsenay TAS SOYLU

Role: PRINCIPAL_INVESTIGATOR

Izmir KAtip Celebi University, Faculty of Health Sciences, Department of Pschiatric Nursing

Locations

Ege University

Izmir, Bornova, Turkey (Türkiye)

Izmir Katip Celebi University

Izmir, Cigli, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

IRB Number: 21-11T/23

Identifier Type: -

Identifier Source: org_study_id