Domestic ViolenceNCT04758741
Investigating the Impact of Acceptance and Commitment Therapy on Resiliency in Women Affected by Domestic Violence
A study testing Acceptance and Commitment Therapy in people with Domestic Violence, run by Fatemeh Khakshoor at 1 site in Iran.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Domestic Violence
- What is being tested?
- Acceptance and Commitment Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteIran
- Study dates
- 28 Nov 2020to 1 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Sampling:
In this project, (80 people) eligible women (with at least one score from the CTS2 questionnaire) are selected through available health centers in the villages covered by Mashhad-e-Kobeh Health Center and Mashhad-e-Koboeh Health Center by available sampling method. They are randomly divided into intervention and control groups.
Randomization type:
Randomization is blockchain. 20 blocks with a volume of 4 are used, two allocations for the control group and two allocations for the intervention group. Random sequencing is done using a web-based random site (https://www.sealedenvelope.com).
Sequence Hiding: Sequence hiding is when someone outside the research team has a random assignment list. As soon as a person is eligible to participate in the study, the sampler contacts the person who has a random assignment sequence and he / she gives the code to the participants to enter the study according to the sequence list.
Acceptance and commitment therapy sessions are held by a researcher who has learned the workshop before starting the project. In the evaluation phase, one week and one month after the intervention, the questionnaires are completed by trained questioners. The statistical consultant who will help analyze the data is unaware of the codes of the participants in the groups. Therefore, the study will be of the three-blind type.
Data collection method:
Questionnaires are completed by pre-intervention interviews by trained researchers and samplers and in the evaluation phase after the intervention and follow-up by trained interviewers. Before starting the study, questioners with high public and social relations are selected for sampling and during a session, the necessary training is given to them by the researcher. During the briefing, the objectives of the study and the work process, the sampling method, the confidentiality of customer information and the privacy of the participant, and all ethical principles related to domestic violence research are taught to the samplers.
Data collection tools:
The instruments studied in this study include Demographic Questionnaire, CTS2 Conflict Resolution Tactics Questionnaire (to determine the status of violence) and Connor and Davidson Resilience Questionnaire (to determine the status of resilience).
Hypothesis:
Acceptance and commitment to therapy affect women's resilience to domestic violence.
all purpose: The effect of treatment acceptance and commitment on the resilience of women affected by domestic violence is determined.
Specific objectives:
Determining and comparing the mean resilience score in the intervention and control groups, before, one week after the intervention and one month after the intervention.
Functional purpose:
If the effectiveness of acceptance and commitment therapy in improving the resilience of women affected by domestic violence is confirmed, this intervention method can be used in counseling centers and its use can be taught to service providers, especially midwives. Applying this method will probably be effective in reducing the rate of violence and mutual violence against women, promoting women's health, improving marital relations and marital satisfaction, strengthening the family and reducing the rate of divorce.
- Conditions
- Domestic Violence
- Being tested
- Acceptance and Commitment Therapy, placebo
- Keywords
- Acceptance and commitment therapy, Resiliency, Domestic violence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment TherapyBehavioural
Investigating the impact of Acceptance and Commitment Therapy on Resiliency in women affected by domestic violence
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from before the intervention to one week and one month after the intervention
Secondary outcomes (1)
Change in the experience of domestic violence
A violence woman is a woman who has answered at least one question from the (cts2) questionnaire.The minimum score on this scale is zero and the maximum score is 432. A higher score indicates more experience of violence and a worse situation.
Measured: from before the intervention to one month after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start28 Nov 2020
- Primary completion20 Apr 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Domestic ViolenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatemeh Khakshoor
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fatemeh Khakshoor, Arak University of Medical Sciences
- Investigators
- abed majidi, phd, Study chairazam moslemi, phd, Study chair, Arak University of Medical Sciencessakineh taherkhani, phd, Principal investigator, Arak University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04758741
- Sponsor's protocol ID
- IR.ARAKMU.REC.1399.226
- Status last verified
- Feb 2022
- First submitted
- 25 Jan 2021
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Impact of Acceptance and Commitment Therapy on Resiliency in Women Affected by Domestic Violence
- ClinicalTrials.gov ID
- NCT04758741
- Acronym / sponsor ID
- IR.ARAKMU.REC.1399.226
- Conditions
- Domestic Violence
- Keywords
- Acceptance and commitment therapy, Resiliency, Domestic violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Fatemeh KhakshoorUniversity, hospital or other
- Study start
- 28 Nov 2020 (actual)
- Primary completion
- 20 Apr 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 17 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Sampling:
In this project, (80 people) eligible women (with at least one score from the CTS2 questionnaire) are selected through available health centers in the villages covered by Mashhad-e-Kobeh Health Center and Mashhad-e-Koboeh Health Center by available sampling method. They are randomly divided into intervention and control groups.
Randomization type:
Randomization is blockchain. 20 blocks with a volume of 4 are used, two allocations for the control group and two allocations for the intervention group. Random sequencing is done using a web-based random site (https://www.sealedenvelope.com).
Sequence Hiding: Sequence hiding is when someone outside the research team has a random assignment list. As soon as a person is eligible to participate in the study, the sampler contacts the person who has a random assignment sequence and he / she gives the code to the participants to enter the study according to the sequence list.
Acceptance and commitment therapy sessions are held by a researcher who has learned the workshop before starting the project. In the evaluation phase, one week and one month after the intervention, the questionnaires are completed by trained questioners. The statistical consultant who will help analyze the data is unaware of the codes of the participants in the groups. Therefore, the study will be of the three-blind type.
Data collection method:
Questionnaires are completed by pre-intervention interviews by trained researchers and samplers and in the evaluation phase after the intervention and follow-up by trained interviewers. Before starting the study, questioners with high public and social relations are selected for sampling and during a session, the necessary training is given to them by the researcher. During the briefing, the objectives of the study and the work process, the sampling method, the confidentiality of customer information and the privacy of the participant, and all ethical principles related to domestic violence research are taught to the samplers.
Data collection tools:
The instruments studied in this study include Demographic Questionnaire, CTS2 Conflict Resolution Tactics Questionnaire (to determine the status of violence) and Connor and Davidson Resilience Questionnaire (to determine the status of resilience).
Hypothesis:
Acceptance and commitment to therapy affect women's resilience to domestic violence.
all purpose: The effect of treatment acceptance and commitment on the resilience of women affected by domestic violence is determined.
Specific objectives:
Determining and comparing the mean resilience score in the intervention and control groups, before, one week after the intervention and one month after the intervention.
Functional purpose:
If the effectiveness of acceptance and commitment therapy in improving the resilience of women affected by domestic violence is confirmed, this intervention method can be used in counseling centers and its use can be taught to service providers, especially midwives. Applying this method will probably be effective in reducing the rate of violence and mutual violence against women, promoting women's health, improving marital relations and marital satisfaction, strengthening the family and reducing the rate of divorce.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Acceptance and commitment treatment | Experimental | Behavioral: Acceptance and Commitment TherapyThe 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. |
| Health Education | Sham comparator | Other: placeboThis 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and Commitment TherapyInvestigating the impact of Acceptance and Commitment Therapy on Resiliency in women affected by domestic violence | Behavioural | Acceptance and commitment treatment |
| placeboThis 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 | Health Education |
Primary outcome
change of Resiliency
Time frame: from before the intervention to one week and one month after the intervention
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.
1 secondary outcome
Change in the experience of domestic violence
Time frame: from before the intervention to one month after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
abed majidi, phd study chair
azam moslemi, phd study chair
Arak University of Medical Sciences
sakineh taherkhani, phd principal investigator
Arak University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy in people with Domestic Violence, run by Fatemeh Khakshoor at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of Resiliency (time frame: from before the intervention to one week and one month after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2022.