Tidal Model's Effects on Emotion Regulation and Recovery

NCT06022497 | Completed

• 1 other identifier: IRB Number: 21-11T/23
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

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.

Conditions

Depression

Keywords

Emotional Regulation; Psychiatric Nursing; Tidal Model; Recovery

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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.

  before and end of the interventions (eight weeks)

Secondary Outcomes (1)

• Nursing Outcome Criteria

  before and end of the interventions (eight weeks)

Study Arms (2)

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.

Other: Tidal Model Based Emotion Regulation Interventions

Control Group

NO INTERVENTION

The control group received only routine treatment.

Interventions

Tidal Model Based Emotion Regulation Interventions 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.

Intervention Group

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Izmir Katip Celebi University: lead
• Ege University: collaborator

Study Sites (2)

Ege University

Izmir, Bornova, 35100, Turkey (Türkiye)

Location

Izmir Katip Celebi University

Izmir, Cigli, 35620, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Depression; Emotional Regulation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Self-Control; Social Behavior

Study Officials

• Mahire Olcay Çam, Prof. Dr.

  Ege University, Faculty of Nursing, Department of Pschiatric Nursing

  STUDY DIRECTOR

• Gulsenay TAS SOYLU

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: September 5, 2023
• Study Start: April 1, 2022
• Primary Completion: May 5, 2023
• Study Completion: June 23, 2023
• Last Updated: September 8, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)