NCT05118438

Brief Summary

Objectives: We aimed to (1) develop a caring program for health promotion among women who experienced trauma and (2) evaluate its effect on post-traumatic stress, depression, health-promoting behaviors, and self-esteem. Methods: We conducted a quasi-experimental study using a group pre-test/post-test design. Data were collected from 14 women recruited from a self-sufficiency support center for sexually exploited women who experienced trauma, during December 2019-May 2020. Participants were assessed at pre-test, post-test, and at a one-month follow-up. We analyzed changes in outcome variables over time using repeated-measures analysis of variance and paired t-tests.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2019

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 2, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2020

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 12, 2021

Completed
Last Updated

November 12, 2021

Status Verified

November 1, 2021

Enrollment Period

6 months

First QC Date

October 29, 2021

Last Update Submit

November 10, 2021

Conditions

Outcome Measures

Primary Outcomes (4)

  • post-traumatic stress

    PTS was measured using the PCL-5, which was developed by Weathers et al. (1993), revised by Weathers et al. (2013) as per the revised PTSD definition in the DSM-5, and translated into Korean by Kim et al. (2017). The Korean version of the PCL for the DSM-5 (PCL-5-K) contains 20 items, and each scored from 0 (not at all) to 4 (extremely). The score depended on the severity of the symptom caused by stress related to traumatic events during the past month. Possible scores ranged from 0 to 80, with a score of 37 or above indicating a PTSD diagnosis, and higher scores suggesting severe PTSD symptoms (Kim et al., 2017). Cronbach's alpha coefficient for the PCL-5-K was .97 among Korean veterans of the Vietnam War (Kim et al., 2017) and .89 in the current study.

    one month after the intervention

  • depression

    Depression was assessed using the Center for Epidemiologic Studies Depression Scale (CES-D), developed by Radloff (1977), and translated into Korean by Chon and Rhee (1992). The Korean version of the CES-D contains 20 items rated on a 4-point Likert scale (0 = rarely or never; to 3 = all the time), according to how respondents felt during the past week. Possible scores ranged from 0 to 60, with a score of 16 or above indicating depressive symptoms, and higher scores indicating higher levels of depression (Radloff, 1977). Cronbach's alpha coefficient for the Korean CES-D was .89 among Korean adults (Chon \& Rhee, 1992) and .78 in our study.

    one month after the intervention

  • health-promoting behaviors

    Health-promoting behaviors were measured using the Health Promoting Lifestyle Profile-II (HPLP-II), developed by Walker et al. (1995) and translated into Korean by Yun and Kim (1999). The Korean version of the HPLP-II comprises 52 items under six subscales: health responsibility (scores ranging from 9-36), physical activity (scores ranging from 8-32), nutrition (scores ranging from 9-36), spiritual growth (scores ranging from 9-36), interpersonal relations (scores ranging from 9-36), and stress management (scores ranging from 8-32). It was rated on a 4-point Likert scale (1=never, 2=sometimes, 3=often, 4=routinely). Possible scores ranged from 52 to 208, with higher scores indicating higher levels of health-promoting behaviors. Cronbach's alpha coefficients were .78, .87, .69, .77, .81, and .73 for health responsibility, physical activity, nutrition, spiritual growth, interpersonal relations, and stress management, respectively.

    one month after the intervention

  • self-esteem

    Self-esteem was assessed using the Rosenberg Self Esteem Scale (RSES), developed by Rosenberg (1965), and translated into Korean by Bae et al. (2014). The Korean version of the RSES (K-RSES) comprises ten items rated on a 4-point Likert scale, ranging from strongly agree to strongly disagree. Possible scores ranged from 10 to 40, with higher scores indicating higher self-esteem. Cronbach's alpha coefficient for the K-RSES was .90 among Korean adults (Bae et al., 2014) and .90 in our study.

    one month after the intervention

Study Arms (1)

Nursing intervention

EXPERIMENTAL

The recruited participants were clients of a self-sufficiency support center for sexually exploited women located in South Korea, recruited through snowball sampling after obtaining permission from the director of the support center.

Other: Health Promotion Nursing Intervention

Interventions

A one-on-one program was conducted over six sessions, with each session ranging from 60 to 120 minutes. The caring program for health promotion included the following concepts: understanding the self; sharing traumatic events and negative emotions; re-framing the meaning of traumatic events; identifying thoughts and physical and emotional responses; developing health-promoting activities; and maintaining a positive attitude during the process of change .

Nursing intervention

Eligibility Criteria

Age20 Years - 37 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOur study targeted sexually exploited women by family member, previous boyfriends, and strangers.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • women aged over 18 years who had experienced a traumatic event, and
  • a PTS score of 64 or lower on the PTSD checklist for DSM-5 (PCL-5) developed by Weathers et al. (1993), revised by Weathers et al. (2013), and translated into Korean by Kim et al. (2017).

You may not qualify if:

  • presence of psychiatric conditions with hallucinations and delusions, and
  • diagnosis of an intellectual disability that would make understanding the intervention procedure difficult. Although a standard cut-off was not present in the PCL-5, women who exceeded 80% (64 points) of the total score were excluded to rule out high-risk women with severe trauma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Location

Study Officials

  • Go-Un Kim

    College of Nursing and Mo-Im Kim Nursing Research Institute, Yonsei University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2021

First Posted

November 12, 2021

Study Start

December 2, 2019

Primary Completion

May 30, 2020

Study Completion

May 30, 2020

Last Updated

November 12, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations