NCT04832451

Brief Summary

Introduction: Interpersonal Relational Role Analysis (IRRA) is a psychosocial group intervention that allows individuals to see the problems they experience in interpersonal relationships and interactions in the group environment and to be handled together with group members. Aim: The present study aims to investigate the effects of IRRA on nursing students' depressive symptoms and coping styles. Method: This study was conducted with randomized controlled, pre-test-post-test control group design and follow-up test patterns. Students with depressive symptoms were randomly assigned to control (n=10) or intervention groups (n=10). Intervention group students received 21 weeks of IRRA intervention. Results: It was determined that IRRA had a positive effect on nursing students' depressive symptoms and coping styles. Discussion: This study is the first to evaluate the effects of IRRA on depressive symptoms and coping styles. Our study provides evidence on the effectiveness of IRRA in reducing the depressive symptoms of nursing students and in managing stress. Implications for Practice: IRRA is a practical and useful intervention that mental health nurses can incorporate and use in their clinical practice while helping individuals to become aware of problems in relationships and roles that may impair their mental health.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
385

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 6, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2019

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 5, 2021

Completed
Last Updated

April 5, 2021

Status Verified

April 1, 2021

Enrollment Period

3 months

First QC Date

April 1, 2021

Last Update Submit

April 1, 2021

Conditions

Keywords

coping stylesdepressive symptomsinterpersonal relational role analysisnursing studentsstress

Outcome Measures

Primary Outcomes (1)

  • Beck Depression Inventory

    The Turkish validity and reliability study of the inventory, which was developed by Beck et al. (1961), was conducted by Hisli (1989). The inventory consists of 21 self-report items that allow evaluating the severity of depressive symptoms rather than the diagnosis of depression. The total score obtained from the scale is evaluated, each item is scored between 0 and 3, and there are no reverse-scored items on the scale. 0-9 points indicate probably no depression, 10-16 points mild depression levels, 17-24 points moderate depression levels, and 25 and above points severe depression. The above-mentioned classification was used in this study. Cronbach's alpha reliability coefficient of the scale was calculated as 0.74 (Hisli, 1989).

    5 months

Secondary Outcomes (1)

  • Coping Styles Inventory

    5 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

The Beck Depression Inventory\[BDI\] (inclusion criteria) was applied face to face to the students who constituted the population (n=385). After the BDI scores were evaluated, the students who met the inclusion criteria were randomly assigned to the intervention and control groups. In a preliminary interview held with the intervention group (n=10), they were informed about the subject of the research, the duration and content of the implementation process, session rules, and that sessions would be audio-recorded. Informed consent forms were obtained from them, and pre-tests (BDI, Coping Styles Inventory\[CSI\]) were applied. A total of 21 90-minute Interpersonal Relational Role Analysis (IRRA) sessions (two sessions a week) were held with the intervention group. 21 sessions of IRRA were applied to the intervention group, once the sessions were completed, post-tests (BDI, CSI) were applied. Three months later, a follow-up test (BDI, CSI) was applied to intervention group.

Behavioral: Interpersonal Relational Role Analysis

Control Group

NO INTERVENTION

The students in the control group were informed about the research, informed consents were obtained from them, and pre-tests (Beck Depression Inventory, Coping Styles Inventory) were applied to them. No intervention was applied to the control group (n=10). Once the Interpersonal Relational Role Analysis sessions were completed, post-tests (Beck Depression Inventory, Coping Styles Inventory) were applied to the control group. Three months later, a follow-up test (Beck Depression Inventory, Coping Styles Inventory) was applied to control groups. After the follow-up test, the participants in the control group were referred to the psychological support unit of the university.

Interventions

Interpersonal Relational Role Analysis (IRRA) is a psychosocial group intervention that allows individuals to see the problems they experience in interpersonal relationships and interactions in the group environment and to be handled together with group members. Similar to Yalom's interactional group therapy model, IRRA sessions comprise warm up, the stages of setting the agenda, working, evaluating, and getting feedback from observers, which are based on the 'here and now' principle. IRRA helps to safely examine the roles in which group members are "stuck," in a group environment which is a small example of social life, and these roles are addressed in six steps.

Intervention Group

Eligibility Criteria

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

You may qualify if:

  • being a nursing student at the university during the research (November 2018-April 2019),
  • not having any disability that would cause difficulties in filling in the data collection tools or during sessions,
  • scoring scores indicating mild to moderate depression from the Beck Depression Inventory,
  • agreeing to participate in the research,
  • being over 18 years old.

You may not qualify if:

  • scoring scores indicating severe depression from the Beck Depression Inventory (severe depression requires psychopharmacological treatment).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University Faculty of Nursing

Ankara, 06230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Gülsüm ANÇEL, PhD

    Ankara University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: randomized controlled, pre-test-post-test control group design and follow-up test patterns
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Dr.

Study Record Dates

First Submitted

April 1, 2021

First Posted

April 5, 2021

Study Start

November 6, 2018

Primary Completion

January 24, 2019

Study Completion

April 24, 2019

Last Updated

April 5, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations