NCT06687278

Brief Summary

This interventional study aims to examine the impact of the Interpersonal Relationship Psychotherapy-Based Intervention Program on the psychosocial well-being of female victims of intimate partner violence. The main questions to be answered are the following:

  1. 1.Is the Interpersonal Relationship Psychotherapy-Based Intervention Program effective on the interpersonal problems of female victims of intimate partner violence?
  2. 2.Is the Interpersonal Relationship Psychotherapy-Based Intervention Program effective on the mental well-being of female victims of intimate partner violence?

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

November 11, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 13, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

February 3, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

April 29, 2025

Status Verified

April 1, 2025

Enrollment Period

3 months

First QC Date

November 11, 2024

Last Update Submit

April 25, 2025

Conditions

Keywords

Intimate Partner ViolencePsychological Well-BeingInterpersonal RelationsInterpersonal PsychotherapyMental Health

Outcome Measures

Primary Outcomes (6)

  • Inventory of Interpersonal Problems Circumplex Scales (IIP-C)

    The scale was developed by Alden and colleagues for the purpose of assessing interpersonal functioning in the context of personal stress and difficulties. The scale employs a 5-point Likert-type response format, comprising a total of 32 items that assess various domains of interpersonal functioning. The scale comprises eight subscales, each comprising four items. Higher scores on the total scale and its constituent subscales indicate elevated levels of interpersonal stress and the presence of specific interpersonal difficulties. The Turkish validity and reliability study was conducted by Akyunus and Gencoz (2016), and the total scale Cronbach's alpha coefficient was found to be 0.86. The scale has been demonstrated to possess sufficient validity and reliability to be employed in research on interpersonal attitudes and behaviours in Turkey and in clinical applications.

    The scale will be administered during the second individual interview of the intervention phase.

  • Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)

    The scale was developed by Tennant and colleagues as a means of measuring the mental well-being levels of individuals. The scale employs a 5-point Likert scale, with a minimum score of 14 and a maximum score of 70. The scale is scored according to the following key: 1=strongly disagree, 2=disagree, 3=somewhat agree, 4=agree, 5=strongly agree. The scale comprises 14 items, with higher scores indicative of elevated levels of psychological well-being. The reliability of the scale was evaluated in studies conducted with individuals aged 16 and above. The Cronbach alpha coefficient for the scale was found to be 0.89. The test-retest reliability coefficient of the scale was found to be 0.83. The Turkish reliability and validity study of the scale was conducted by Keldal (2015). The Cronbach's Alpha internal consistency reliability coefficient of the Turkish version of the scale was found to be 0.92.

    The scale will be administered during the second individual interview of the intervention phase.

  • Inventory of Interpersonal Problems Circumplex Scales (IIP-C)

    The scale was developed by Alden and colleagues for the purpose of assessing interpersonal functioning in the context of personal stress and difficulties. The scale employs a 5-point Likert-type response format, comprising a total of 32 items that assess various domains of interpersonal functioning. The scale comprises eight subscales, each comprising four items. Higher scores on the total scale and its constituent subscales indicate elevated levels of interpersonal stress and the presence of specific interpersonal difficulties. The Turkish validity and reliability study was conducted by Akyunus and Gencoz (2016), and the total scale Cronbach's alpha coefficient was found to be 0.86. The scale has been demonstrated to possess sufficient validity and reliability to be employed in research on interpersonal attitudes and behaviours in Turkey and in clinical applications.

    The scale will be administered at the close of the eighth session.

  • Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)

    The scale was developed by Tennant and colleagues as a means of measuring the mental well-being levels of individuals. The scale employs a 5-point Likert scale, with a minimum score of 14 and a maximum score of 70. The scale is scored according to the following key: 1=strongly disagree, 2=disagree, 3=somewhat agree, 4=agree, 5=strongly agree. The scale comprises 14 items, with higher scores indicative of elevated levels of psychological well-being. The reliability of the scale was evaluated in studies conducted with individuals aged 16 and above. The Cronbach alpha coefficient for the scale was found to be 0.89. The test-retest reliability coefficient of the scale was found to be 0.83. The Turkish reliability and validity study of the scale was conducted by Keldal (2015). The Cronbach's Alpha internal consistency reliability coefficient of the Turkish version of the scale was found to be 0.92.

    The scale will be administered at the close of the eighth session.

  • Inventory of Interpersonal Problems Circumplex Scales (IIP-C)

    The scale was developed by Alden and colleagues for the purpose of assessing interpersonal functioning in the context of personal stress and difficulties. The scale employs a 5-point Likert-type response format, comprising a total of 32 items that assess various domains of interpersonal functioning. The scale comprises eight subscales, each comprising four items. Higher scores on the total scale and its constituent subscales indicate elevated levels of interpersonal stress and the presence of specific interpersonal difficulties. The Turkish validity and reliability study was conducted by Akyunus and Gencoz (2016), and the total scale Cronbach's alpha coefficient was found to be 0.86. The scale has been demonstrated to possess sufficient validity and reliability to be employed in research on interpersonal attitudes and behaviours in Turkey and in clinical applications.

    The scale will be administered within the fourth week following the eighth session.

  • Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)

    The scale was developed by Tennant and colleagues as a means of measuring the mental well-being levels of individuals. The scale employs a 5-point Likert scale, with a minimum score of 14 and a maximum score of 70. The scale is scored according to the following key: 1=strongly disagree, 2=disagree, 3=somewhat agree, 4=agree, 5=strongly agree. The scale comprises 14 items, with higher scores indicative of elevated levels of psychological well-being. The reliability of the scale was evaluated in studies conducted with individuals aged 16 and above. The Cronbach alpha coefficient for the scale was found to be 0.89. The test-retest reliability coefficient of the scale was found to be 0.83. The Turkish reliability and validity study of the scale was conducted by Keldal (2015). The Cronbach's Alpha internal consistency reliability coefficient of the Turkish version of the scale was found to be 0.92.

    The scale will be administered within the fourth week following the eighth session.

Secondary Outcomes (5)

  • Beck Depression Inventory (BDI)

    in the second interview with the participant

  • Beck Depression Inventory (BDI)

    end of session 8

  • Intervention Program Evaluation Form

    end of session 8

  • Beck Depression Inventory (BDI)

    The scale will be administered within the fourth week following the eighth session.

  • Intervention Program Evaluation Form

    The scale will be administered within the fourth week following the eighth session.

Study Arms (2)

The Initiative Group

EXPERIMENTAL

Participants in this group will receive an Interpersonal Relationship Psychotherapy-Based Intervention Program consisting of eight individual sessions.

Behavioral: Interpersonal Relationship Psychotherapy-Based Intervention Program

The Control Group

NO INTERVENTION

The control group will be left unaltered throughout the course of the study. In the event that participants are already undergoing medical and/or supportive care outside of the parameters of the study, they shall continue to receive such care according to standard protocols.

Interventions

The Interpersonal Relationship Psychotherapy-Based Intervention Program is based on IPR and developed with reference to relevant literature and a previously published study (Cort et all., 2014). Subsequent to the development of the program, a series of expert opinions were obtained from seven specialists in the field. The Interpersonal Relationship Psychotherapy-Based Intervention Program is a 2.5-3 month program comprising eight individual sessions. The program is designed to be administered on a weekly basis, with each session lasting approximately 45-60 minutes. The participants in this group will receive an Interpersonal Relationship Psychotherapy Based Intervention Programme, which consists of eight individual sessions.

The Initiative Group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe research is focused on adult female participants who have experienced violence perpetrated by an intimate partner. Consequently, only individuals of the female gender are eligible to participate.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Proficiency in the Turkish language, including the ability to speak and understand it.
  • Exposure to any form of violence perpetrated by an intimate partner.

You may not qualify if:

  • Exposure to violence by an individual other than an intimate partner for the purpose of maintaining group homogeneity.
  • Presence of sensory loss, including but not limited to hearing and vision.
  • Physical injury and/or disability resulting from violence that precludes participation in the intervention program.
  • Diagnosis of schizophrenia spectrum disorders and other psychotic disorders.
  • Presence of active self-destructive thoughts and/or plans.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florence Nightingale Faculty of Nursing

Istanbul, 34381, Turkey (Türkiye)

RECRUITING

Related Publications (12)

  • Ruiz-Perez I, Plazaola-Castano J. Intimate partner violence and mental health consequences in women attending family practice in Spain. Psychosom Med. 2005 Sep-Oct;67(5):791-7. doi: 10.1097/01.psy.0000181269.11979.cd.

    PMID: 16204440BACKGROUND
  • Mufson, L., Dorta, K.P., Moreau, D. and Weissman, M.M., 2004, Interpersonal Psychotherapy for Depressed Adolescents, 2nd ed., The Guilford Press, New York, ISBN-13: 978-1-59385-042-5.

    BACKGROUND
  • Ravitz P, Watson P, Lawson A, Constantino MJ, Bernecker S, Park J, Swartz HA. Interpersonal Psychotherapy: A Scoping Review and Historical Perspective (1974-2017). Harv Rev Psychiatry. 2019 May/Jun;27(3):165-180. doi: 10.1097/HRP.0000000000000219.

    PMID: 30883446BACKGROUND
  • Cort, N. A., Cerulli, C., Poleshuck, E. L., Bellenger, K. M., Xia, Y., Tu, X., Mazzotta, C. M. and Talbot, N. L., 2014, Interpersonal psychotherapy for depressed women with histories of intimate partner violence, Psychological trauma: theory, research, practice, and policy, 6 (6), 700-707.

    BACKGROUND
  • Almis BH, Kutuk EK, Gumustas F, Celik M. Risk Factors for Domestic Violence in Women and Predictors of Development of Mental Disorders in These Women. Noro Psikiyatr Ars. 2018 Mar 19;55(1):67-72. doi: 10.29399/npa.19355. eCollection 2018 Mar.

    PMID: 30042644BACKGROUND
  • Almis BH, Gumustas F, Kutuk EK, 2020, Effects of Domestic Violence Against Women on Mental Health of Women and Children, Current Approaches in Psychiatry, 12 (2), 232-242. doi: 10.18863/pgy.567635

    BACKGROUND
  • Atar, A.O. & Aydın, P.C., 2019, Evidence for Efficacy of interpersonal psychotherapy, Interpersonal Relations Psychotherapy, In Aydın, N., Omay, O. (ed), Türkiye Clinics, Ankara, 1st ed., 12-18.

    BACKGROUND
  • Akyunus, M., & Gencoz, T., 2016, Psychometric properties of the Inventory of Interpersonal Problems Circumplex Scales short form: a reliability and validity study, Dusunen Adam The Journal of Psychiatry and Neurological Sciences, 29 (1), 36-48. DOI: 10.5350/DAJPN2016290104

    BACKGROUND
  • Alden LE, Wiggins JS, Pincus AL. Construction of circumplex scales for the Inventory of Interpersonal Problems. J Pers Assess. 1990 Winter;55(3-4):521-36. doi: 10.1080/00223891.1990.9674088. No abstract available.

    PMID: 2280321BACKGROUND
  • Keldal, G., 2015, Turkish Version of the Warwick-Edinburgh Mental Well-Being Scale: A validity and reliability study, The Journal of Happiness & Well-Being, 3 (1), 103-115.

    BACKGROUND
  • Hisli, N., 1989, Validity and reliability of Beck Depression Inventory for university students, Journal of Psychology, 7 (23), 3-13.

    BACKGROUND
  • Turgut EO, Cam MO. The Effect of Tidal Model-Based Psychiatric Nursing Approach on the Resilience of Women Survivors of Violence. Issues Ment Health Nurs. 2020 May;41(5):429-437. doi: 10.1080/01612840.2019.1672222. Epub 2020 Mar 18.

    PMID: 32186926BACKGROUND

Related Links

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Cennet Kara Özçalık

    Istanbul Universty-Cerrahpasa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cennet Kara Özçalık

CONTACT

Asst. Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The study will employ a pretest-posttest-follow-up test experimental design with a control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 11, 2024

First Posted

November 13, 2024

Study Start

February 3, 2025

Primary Completion

May 1, 2025

Study Completion

June 1, 2025

Last Updated

April 29, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

The requisite legal and ethical permissions for the research were obtained on the condition that the data would not be shared with third parties.

Locations