NCT04758741

Brief Summary

This study is a randomized controlled counseling intervention with pre-test, post-test and control groups. After obtaining informed consent from 80 women affected by domestic violence that referred to the health centers of the villages covered by Al-Kooh Mashhad Health Center (Mashhad Al-Kooh Health Center, Michan, Mosleh Abad) and Mashhad Al-Kobeh Health Center, and are eligible to enter Rct are. A woman who has been subjected to domestic violence is someone who has obtained at least one score on the (cts2) questionnaire . Then, these people are randomly divided into two groups of intervention (n = 40) and control (n = 40). The members of the intervention group in groups of 10 are treated in 8 sessions of 90 minutes once a week based on "acceptance and commitment treatment" based on Hayes (2006) approach by a trained consultant (researcher) in Mashhad AL-koubeh Health Center. The control group also receives 8 counseling sessions once a week by the same "health education" consultant in groups of 10 at the same center. One week after the end of the eighth session and one month later, the questionnaires are completed again by trained questioners for both groups. The instruments studied in this study include demographic questionnaire, conflict resolution tactics questionnaire (cts 2) and resilience questionnaire (Connor-Davidson). Data analysis is performed using descriptive and inferential statistics with SPSS software version 23.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2020

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

November 28, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 17, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

February 17, 2022

Status Verified

February 1, 2022

Enrollment Period

5 months

First QC Date

January 25, 2021

Last Update Submit

February 16, 2022

Conditions

Keywords

Acceptance and commitment therapyResiliencyDomestic violence

Outcome Measures

Primary Outcomes (1)

  • change of Resiliency

    Resilience refers to a person's score on the Connor \& Davidson (2003) Questionnaire (CD-RISC).The minimum score on this scale is zero and the maximum score is 100. A higher score indicates more resilience, meaning a better situation.

    from before the intervention to one week and one month after the intervention

Secondary Outcomes (1)

  • Change in the experience of domestic violence

    from before the intervention to one month after the intervention

Study Arms (2)

Acceptance and commitment treatment

EXPERIMENTAL

The members of the intervention group receive one session of acceptance and commitment treatment per week according to Hayes (2006) approach in groups of 10 in 8 sessions of 90 minutes by a trained counselor (researcher) in Mashhadalkoubeh Health Center.

Behavioral: Acceptance and Commitment Therapy

Health Education

SHAM COMPARATOR

This rct has one arm and health education is done only for the purpose of blinding the study so that the participant does not know which of the control or intervention groups it is in and has no comparative aspect and has nothing to do with resilience.

Other: placebo

Interventions

Investigating the impact of Acceptance and Commitment Therapy on Resiliency in women affected by domestic violence

Acceptance and commitment treatment
placeboOTHER

This rct has one arm and health education is done only for the purpose of blinding the study so that the participant does not know which of the control or intervention groups it is in and has no comparative aspect and has nothing to do with resilience

Health Education

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsHaving experience of domestic violence by the husband for at least the last year.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Giving informed written consent.
  • Having experience of domestic violence by the husband for at least the last six months (obtaining at least one grade from the aggressive form of the cts2 questionnaire).
  • Ability to speak Persian.
  • Having at least a third grade of secondary education (to Reason for being able to understand the concepts related to intervention and being able to do homework)
  • Being Iranian.
  • Being married.
  • Not being pregnant during pregnancy and postpartum (up to 6 months postpartum).
  • Not taking psychedelic, anti-anxiety and anti-depressant drugs In the interval of 6 months before participating in the study and during the study.
  • No consciousness disorder.
  • No history of hospitalization in the psychiatric ward.
  • No incurable physical disease such as cancer Or malignant tumors.
  • Not experiencing any severe stress such as divorce, accident, bereavement of relatives in the last six months.
  • No simultaneous participation in counseling courses with content similar to the present intervention.

You may not qualify if:

  • Not participating in two or more treatment sessions.
  • Experiencing any severe stress during the study, such as incurable physical illness such as cancer or malignant tumors, pregnancy during the study, divorce, accident, bereavement of relatives.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mashhad Alkoubeh Health Center

Arak, Markazi Province, 3815966788, Iran

Location

MeSH Terms

Interventions

Acceptance and Commitment Therapy

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • abed majidi, phd

    STUDY CHAIR
  • azam moslemi, phd

    Arak University of Medical Sciences

    STUDY CHAIR
  • sakineh taherkhani, phd

    Arak University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Sequencing will be centralized in such a way that the list of random allocation sequences is provided to someone outside the research team. As soon as a person is eligible to participate in the study, the sampler contacts the person who has the random assignment sequence and he or she, according to the sequence list, gives the code to the participants to enter the study. Acceptance and commitment therapy sessions are held by a trained researcher. At the evaluation stage, one week and one month after the intervention, the questionnaires are completed by trained questioners. The statistical consultant who will assist in the data analysis will be unaware of the codes of the participants in the groups. Therefore, the study will be of the three-blind type.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Individuals are randomly divided into two groups: intervention (n = 40) and control (n = 40). The members of the intervention group in groups of 10 will receive acceptance and commitment treatment in 8 90-minute sessions once a week according to Hayes (2006) approach in Mashhad Al-Koubeh Health Center by a consultant (researcher) trained. The control group also receives 8 counseling sessions per week by the same "Health Education" consultant in groups of 10 in the same center. One week after the end of the eighth session and one month later, the questionnaires are completed again by trained questioners for both groups
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

January 25, 2021

First Posted

February 17, 2021

Study Start

November 28, 2020

Primary Completion

April 20, 2021

Study Completion

June 1, 2021

Last Updated

February 17, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations