NCT04105933

Brief Summary

Women experience negative psychological outcomes long after the violent relationship has ended. Women suffer constant trauma and psychological distress being in emotional and mentally abusive relationship. Present study developed Culturally sensitive cognitive-behaviour therapy (CBT) to fit the client's cultural identity, context, and preferences.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

2 active sites

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

March 12, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2018

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 26, 2019

Completed
Last Updated

October 25, 2019

Status Verified

September 1, 2019

Enrollment Period

9 months

First QC Date

September 25, 2019

Last Update Submit

October 24, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Psychological symptoms

    Brief Symptom Inventory (BSI) was used to assess psychological complaints

    Change from baseline to 16 weeks

Secondary Outcomes (2)

  • Self esteem

    Change from baseline to 16 weeks

  • Forgiveness

    Change from baseline to 16 weeks

Study Arms (2)

CS-CBT

EXPERIMENTAL

Culturally sensitive-CBT intervention was comprised of 16 sessions of cognitive behavioral therapy focused on culturally-specific beliefs and attitude.

Other: CS-CBT

CBT

ACTIVE COMPARATOR

CBT intervention was comprised of 16 sessions of cognitive behavioral therapy.

Other: CBT

Interventions

CS-CBTOTHER

Culturally sensitive Cognitive Behavioural Therapy was delivered individually, focused on potential cultural beliefs and attitudes that might collide with core values of CBT.

CS-CBT
CBTOTHER

CBT was delivered at an individual level, dealing with thoughts, feelings and behaviours in the present. Thoughts are identified and then challenged, to make them more objective and rational.

CBT

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women victim of intimate partner violence
  • Still in relationship with abuser
  • Willing to attend 16-weeks sessions

You may not qualify if:

  • In need of clinical supervision or treatment
  • Severe mental disorders
  • Cognitive disorders
  • Refused to give written consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gyansaneejvani

Būndi, Rajasthan, India

Location

NMP Medical Research Institute

Jaipur, Rajasthan, India

Location

Study Officials

  • Neha Sharma, PhD

    Warwick Research Services

    STUDY DIRECTOR
  • Rachana Khandelwal, PhD

    NMP Medical Research Institute, India

    STUDY CHAIR
  • Anurag Sharma, MPhil

    Patan Girls College, India

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2019

First Posted

September 26, 2019

Study Start

March 12, 2017

Primary Completion

December 15, 2017

Study Completion

February 11, 2018

Last Updated

October 25, 2019

Record last verified: 2019-09

Locations