Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04832451 |
| Other study ID # |
56786525-050.04.04-6988 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 6, 2018 |
| Est. completion date |
April 24, 2019 |
Study information
| Verified date |
April 2021 |
| Source |
Ankara University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Aim and Design Aiming to investigate the effects of Interpersonal Relational Role Analysis
(IRRA) on nursing students' depressive symptoms and coping styles, this study was conducted
with randomized controlled, pre-test-post-test control group design and follow-up test
patterns.
Research population and sample The study was conducted in the 2018-2019 academic year
(November 2018 - April 2019). The research population comprised second-year nursing students
studying at two different state universities in the 2018-2019 academic year (n=385). Since
the researcher had an instructional relationship with the first-, third-, and fourth-year
students, the study was performed with the second-year students. The number of people to be
included in the groups was calculated in the G*Power (3.1.9.2) package program based on a
research. As a result of the power analysis with an effect size of 0.7, a power of 80%, and
an alpha level (probability of making a type I error) of 0.05, the sample size was calculated
as a total of 16 students (8 in the intervention and 8 in the control group). Considering the
possibility of drop-outs during the study, the research was conducted with a total of 20
students (10 in the intervention and 10 in the control group). Effective implementation of
IRRA requires interaction among the group members; therefore, the intervention group was
composed of students studying in the same class. To prevent interaction between the control
group and the intervention group, the control group was composed of students studying at a
different state university in the same city with the same education program. The students who
met the inclusion criteria and agreed to participate in the study were assigned to the
intervention and control groups with the Research Randomizer program. Randomization was
performed by a researcher who was not included in the research. To make the study a
single-blind study, students were not informed about the group to which they were assigned.
Inclusion/exclusion criteria Inclusion criteria were as follows: (a) being a nursing student
at the university during the research (November 2018-April 2019), (b) not having any
disability that would cause difficulties in filling in the data collection tools or during
sessions, (c) scoring scores indicating mild to moderate depression from the Beck Depression
Inventory, (d) agreeing to participate in the research, and (e) being over 18 years old.
Exclusion criteria were as follows: (a) scoring scores indicating severe depression from the
Beck Depression Inventory (severe depression requires psychopharmacological treatment).
Data Collection Tools Sociodemographic Characteristics Form This form, developed by the
researchers, contains questions about students' sociodemographic characteristics such as age,
gender, marital status, economic status, and parental educational status.
Beck Depression Inventory (BDI) 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.
Coping Styles Inventory (CSI) The scale has 30 items and five sub-dimensions rated on a
four-point Likert-type scale. To calculate the score from the "seeking social support"
sub-dimension, the first and ninth items are reversely scored. The scores of the
sub-dimensions are calculated by dividing the total scores obtained from the items by the
total number of items. High scores from the self-confident approach, optimistic approach, and
seeking social support sub-dimensions indicate that effective methods are used to cope with
stress whereas high scores from the helpless approach and submissive approach sub-dimensions
indicate that ineffective methods are used to cope with stress. Cronbach's alpha reliability
coefficient was calculated as 0.69 for the self-confident approach sub-dimension, 0.63 for
the optimistic approach sub-dimension, 0.72 for the seeking social support sub-dimension,
0.67 for the helpless approach sub-dimension, and 0.68 for the submissive approach
sub-dimension.
Implementation First, the BDI (inclusion criteria) was applied face to face to the students
who constituted the population (n=385) (06-08 November 2018). 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 10 students in the intervention group, they were
informed in a confidential manner about the subject of the research, the duration and content
of the implementation process, what was expected from the participants, session rules, the
place where the sessions would be held, and that sessions would be audio-recorded. Also,
informed consent forms were obtained from them, and pre-tests (BDI, CSI) were applied (14
November 2018). Likewise, the students in the control group were informed about the research,
informed consents were obtained from them, and pre-tests were applied to them (15 November
2018).
A total of 21 90-minute IRRA sessions (two sessions a week) were held with the 10 students in
the intervention group between 16.11.2018 and 20.01.2019. The sessions were chaired by a
group administrator (the researcher) and two observers (faculty members in the field of
mental health nursing). The group administrator received IRRA training from faculty members
who developed the IRRA model. Before the sessions, warm-up exercises were performed in order
to develop a sense of trust and to increase rapport and interaction among the members. In the
first session, an "acquaintance activity" was held, and the session rules, about which the
participants were informed in the preliminary interview, were again presented for everyone's
approval. In the following sessions, after the warm-up exercises, an agenda-setting round (a
process devoted to setting the agenda) was carried out with the participation of each member.
At this stage, each member was asked whether they experienced an important event they wanted
to share with other members, and then each member summarized which IRRA step they were in and
determined on which step they would work throughout that day's session. After this stage, the
members who wanted to work in the group in that day's session worked on the IRRA steps. In
each session, 45-50 minutes were allocated to examining the IRRA steps. During this time,
participants were given opportunities to express themselves, and the IRRA steps of 2-3
members were discussed in each session, depending on the progress of the group members. Due
to individual differences, some members made rapid progress through the IRRA steps, while it
took others longer to complete the steps. At the end of each session, a 15-20 minute
evaluation round was held with the participation of the observers. During the evaluation, the
group administrator summarized what was discussed in the session. Participants were asked how
they felt during the session, their negative feelings were studied, and it was ensured that
no members left the session with negative feelings. The group administrator and observers
gave empathic and positive feedback to each member due to their efforts to improve and change
themselves. Similarities between the experiences and feelings of the participants were
emphasized. The members thanked each other for confiding in each other. In the last session,
a "separation activity" was held, where the members shared the positive aspects they
discovered about each other, as well as their feelings and thoughts about the ending of the
group.
While 21 sessions of IRRA were applied to the intervention group, no intervention was applied
to the control group. Once the IRRA sessions were completed, post-tests (BDI, CSI) were
applied to the intervention and control groups (January 21-24, 2019). Three months later
(April 2019), a follow-up test (BDI, CSI) was applied to both groups. After the follow-up
test, the participants in the control group were referred to the psychological support unit
of the university.
Data Analysis Data were analysed using the Statistical Package for Social Sciences 22.0. In
the evaluation of the data, the Kolmogorov-Smirnov test was applied to determine whether the
data had a normal distribution or not, regarding the steepness and skewness. As a result of
the analysis, it was found out that the significance value of the Kolmogorov-Smirnov test was
higher than 0.05, the steepness and skewness values were between the range of -1 and +1, and
the data had a normal distribution. The independent samples t test and chi-square test were
used to examine the homogeneity of participant characteristics and outcome variables between
the intervention and control group at baseline.
The versatile variance analysis was performed for the comparison of the group, time, and
group×time interaction among means of BDI and CSI subscale score in the intervention and
control groups. To compare the mean scores among the groups one-way variance analysis in
repeated measurements was used, and "the Bonferroni-adjusted t test for dependent samples"
was used to compare the measurements.
Ethical approval This study was approved by a research ethics committee
(56786525-050.04.04-6988). Written and verbal consent was obtained from the students who
agreed to participate in the study.
