Clinical trial NCT06022497: Tidal Model's Effects on Emotion Regulation and Recovery
Official title: The Effect of Tidal Model-Based Emotion Regulation Nursing Interventions on Recovery in Individuals Diagnosed With Nursing Diagnosis of Impaired Mood Regulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Emotional Regulation
Psychiatric Nursing
Tidal Model
Recovery
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
Collaborators: name: Ege University
First posted: 2023-09-05
Enrollment: 46
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Recovery Assesment Scale
timeFrame: before and end of the interventions (eight weeks)
measure: Difficulties in Emotion Regulation
timeFrame: before and end of the interventions (eight weeks)
measure: Hamilton Depression Rating Scale
timeFrame: before and end of the interventions (eight weeks)
Secondary outcomes:
measure: Nursing Outcome Criteria
timeFrame: before and end of the interventions (eight weeks)
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Ege University
state: Bornova
city: Izmir
country: Turkey
facility: Izmir Katip Celebi University
state: Cigli
Study officials:
affiliation: Ege University, Faculty of Nursing, Department of Pschiatric Nursing
name: Mahire Olcay Çam, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Izmir KAtip Celebi University, Faculty of Health Sciences, Department of Pschiatric Nursing
name: Gulsenay TAS SOYLU
role: PRINCIPAL_INVESTIGATOR
References: