Cognitive Behaviour TherapyNCT06208111
A Clinical Trial of Cognitive Behavior Therapy for Depression, Stigmatization, Excessive Worries, and Emotional Management Among Women Facing Partner Violence
A study testing cognitive behavioral therapy in people with Cognitive Behaviour Therapy, run by Government College University Faisalabad at 1 site in Pakistan.
Trial summary
1. Aim to investigate the effectiveness of Cognitive Behavior Therapy for Depression, Stigmatization, Excessive Worries, and Emotional Management among Women Facing Partner Violence 2. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cognitive Behaviour Therapy
- What is being tested?
- cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Nov 2023to 10 Apr 2024
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women living in the institutions for at least 2 weeks because of partner violence
- Second eligibility criteria would be women with a minimum of 1 year of marital relationship will be included.
- The age range would be 18 -48 years.
- Women whose scores are above average on the partner violence scale would be included in the study
Who cannot join
- Women greater than 48 years and less than 18 years will be excluded.
- Women with medical and psychiatric comorbidities will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
- Aim to investigate the effectiveness of Cognitive Behavior Therapy for Depression, Stigmatization, Excessive Worries, and Emotional Management among Women Facing Partner Violence
- To explore the effectiveness of CBT in managing depressive symptoms, stigma, worries, and emotional disturbance among women facing partner violence.
Read the detailed description
In this Randomized control trial, N=180 participants would be enrolled for eligibility assessment from different shelter homes in the cities of Punjab after the eligibility assessment and screening 108 participants would be allocated to experimental and waitlist treatment conditions. Participants will be allocated through matchable group characteristics. Participant's age range would be between 18 to 45 years. Each of the group will be comprised of the same number of participants. Both groups will be pre-tested and results will be recorded. A cognitive behavior therapy-based treatment plan will be formulated to address Depression, Stigmatization, Excessive Worries, and Emotional Management among Women Facing Partner Violence. 8-10 CBT-based therapeutic sessions with 60 minutes will be conducted with the participant in a one-on-one setting.
- Conditions
- Cognitive Behaviour Therapy
- Being tested
- cognitive behavioral therapy
- Keywords
- Depression Worries Stigma Emotion Cognitive behavior therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive behavioral therapyBehavioural
cognitive behavioral therapy would be used as intervention strategy for women facing partner violence to Clear about actual problems, re-educate about the issue of domestic problems and mental health, Logical expectations, Identify negative automatic thoughts,Thinking errors, and Improve understanding to identify which stressors trigger negative emotions. Moreover, this intervention will help to Prepare women how to deal with stress and overcome the reaction.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Experimental Group:
participants in the experimental group would receive 8-10 Cognitive Behaviour Therapy-based therapeutic sessions. Receives: Behavioral: cognitive behavioral therapy |
| control group | No intervention | Participants in the control group did not receive the said Cognative Behaviour Therapy intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eligibility Assessment:
Initially, we enroll the women for eligibility assessment. Women who live in shelter home will be part of the study. After choosing, the Participants demographic form will be filled out. In demographic form information related to age, marital status, marriage type, family system, children, education and financial status. After this, eligible participants will be referred for psychological evolution.
Measured: 2-4 weeks
Depression:
Depression will be assessed by using Depression Anxiety Stress Scale. A score of 13, 20, 27 9, 14, 19, 18, 25, 33 corresponding to the categorization of mild moderate and sever level of depression, anxiety and stress respectively.
Measured: after allocation 1 week
Stigmatization:
Intimate Partner Violence Stigma Scale will asses stigmatization. Higher score will indicate high-level stigma whereas low score indicate low level of stigma.
Measured: after allocation 1 week
Excessive Worries:
Excessive worries will be assessed by using Generalized Anxiety Scale GAD-7. A score of 4,9,15 corresponding to the categorization of mild moderate and sever level of worries. Score greater than 15 will show the severe level of Anxiety.
Measured: after allocation 1 week
Emotional Management:
Emotional Management will be assessed by using Emotional Regulation Scale. This scale comprised of ten items. Higher score on items 1,3,5,7,8,10 will show the higher level of Cognitive Reappraisal and higher score on items 2, 4, 6, and 9 will show the higher level of Expressive Suppression. Low score on these items will show the lower level of Cognitive Reappraisal and Expressive Suppression.
Measured: after allocation 1 week
Partner Violence:
Karachi Domestic violence scale will be used to assess the intimate partner violence. The lowest score on KDVSS will be 0 and highest score on this scale will be 105.The cut-off score for indication that person facing the domestic abuse will be <29.
Measured: after allocation 1 week
Secondary outcomes (2)
Duration of illness
They will be assessed through interview information
Measured: at the time of pre assessment (1week)
HISTORY Of Domestic violence
they will be assessed through history taking information
Measured: after allocation at pre assessment (1week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start15 Nov 2023
- Primary completion1 Feb 2024 (estimated)
- Study completion10 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Behaviour TherapyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized control trial design will be used in this study. it would be two arm study and there would be two groups an experimental and a waitlist control group. The experimental group will receive intervention and another group will be placed on the waitlist. in this research parallel group design would be used. we will give treatment to all participants in a parallel way. The allocation ratio and framework would be equivalency i.e, the treatment group and control group be equal number of participants
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Government College University Faisalabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qasir Abbas, Government College University Faisalabad
- Investigators
- Qasir Abbas, PHD, Principal investigator, Government College University Faisalabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06208111
- Sponsor's protocol ID
- GovernmentGUF
- Status last verified
- Jan 2024
- First submitted
- 29 Nov 2023
- Last updated
- 17 Jan 2024
- 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 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial of Cognitive Behavior Therapy for Depression, Stigmatization, Excessive Worries, and Emotional Management Among Women Facing Partner Violence
- ClinicalTrials.gov ID
- NCT06208111
- Acronym / sponsor ID
- GovernmentGUF
- Conditions
- Cognitive Behaviour Therapy
- Keywords
- Depression Worries Stigma Emotion Cognitive behavior therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Government College University FaisalabadUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 10 Apr 2024 (estimated)
- First posted
- 17 Jan 2024 (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.
- Aim to investigate the effectiveness of Cognitive Behavior Therapy for Depression, Stigmatization, Excessive Worries, and Emotional Management among Women Facing Partner Violence
- To explore the effectiveness of CBT in managing depressive symptoms, stigma, worries, and emotional disturbance among women facing partner violence.
Detailed description
In this Randomized control trial, N=180 participants would be enrolled for eligibility assessment from different shelter homes in the cities of Punjab after the eligibility assessment and screening 108 participants would be allocated to experimental and waitlist treatment conditions. Participants will be allocated through matchable group characteristics. Participant's age range would be between 18 to 45 years. Each of the group will be comprised of the same number of participants. Both groups will be pre-tested and results will be recorded. A cognitive behavior therapy-based treatment plan will be formulated to address Depression, Stigmatization, Excessive Worries, and Emotional Management among Women Facing Partner Violence. 8-10 CBT-based therapeutic sessions with 60 minutes will be conducted with the participant in a one-on-one setting.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized control trial design will be used in this study. it would be two arm study and there would be two groups an experimental and a waitlist control group. The experimental group will receive intervention and another group will be placed on the waitlist. in this research parallel group design would be used. we will give treatment to all participants in a parallel way. The allocation ratio and framework would be equivalency i.e, the treatment group and control group be equal number of participants
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Behavioral: cognitive behavioral therapyExperimental Group: participants in the experimental group would receive 8-10 Cognitive Behaviour Therapy-based therapeutic sessions. |
| control group | No intervention | –Participants in the control group did not receive the said Cognative Behaviour Therapy intervention |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women living in the institutions for at least 2 weeks because of partner violence
- Second eligibility criteria would be women with a minimum of 1 year of marital relationship will be included.
- The age range would be 18 -48 years.
- Women whose scores are above average on the partner violence scale would be included in the study
Key exclusion criteria (2 listed)
- Women greater than 48 years and less than 18 years will be excluded.
- Women with medical and psychiatric comorbidities will be excluded.
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 |
|---|---|---|
| cognitive behavioral therapycognitive behavioral therapy would be used as intervention strategy for women facing partner violence to Clear about actual problems, re-educate about the issue of domestic problems and mental health, Logical expectations, Identify negative automatic thoughts,Thinking errors, and Improve understanding to identify which stressors trigger negative emotions. Moreover, this intervention will help to Prepare women how to deal with stress and overcome the reaction. | Behavioural | Treatment group |
Primary outcome
Eligibility Assessment:
Time frame: 2-4 weeks
Initially, we enroll the women for eligibility assessment. Women who live in shelter home will be part of the study. After choosing, the Participants demographic form will be filled out. In demographic form information related to age, marital status, marriage type, family system, children, education and financial status. After this, eligible participants will be referred for psychological evolution.
Depression:
Time frame: after allocation 1 week
Depression will be assessed by using Depression Anxiety Stress Scale. A score of 13, 20, 27 9, 14, 19, 18, 25, 33 corresponding to the categorization of mild moderate and sever level of depression, anxiety and stress respectively.
Stigmatization:
Time frame: after allocation 1 week
Intimate Partner Violence Stigma Scale will asses stigmatization. Higher score will indicate high-level stigma whereas low score indicate low level of stigma.
Excessive Worries:
Time frame: after allocation 1 week
Excessive worries will be assessed by using Generalized Anxiety Scale GAD-7. A score of 4,9,15 corresponding to the categorization of mild moderate and sever level of worries. Score greater than 15 will show the severe level of Anxiety.
Emotional Management:
Time frame: after allocation 1 week
Emotional Management will be assessed by using Emotional Regulation Scale. This scale comprised of ten items. Higher score on items 1,3,5,7,8,10 will show the higher level of Cognitive Reappraisal and higher score on items 2, 4, 6, and 9 will show the higher level of Expressive Suppression. Low score on these items will show the lower level of Cognitive Reappraisal and Expressive Suppression.
Partner Violence:
Time frame: after allocation 1 week
Karachi Domestic violence scale will be used to assess the intimate partner violence. The lowest score on KDVSS will be 0 and highest score on this scale will be 105.The cut-off score for indication that person facing the domestic abuse will be <29.
2 secondary outcomes
Duration of illness
Time frame: at the time of pre assessment (1week)
HISTORY Of Domestic violence
Time frame: after allocation at pre assessment (1week)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- 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.
Qasir Abbas, PHD principal investigator
Government College University Faisalabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive behavioral therapy in people with Cognitive Behaviour Therapy, run by Government College University Faisalabad at 1 site in Pakistan.
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 4 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: status not confirmed, as of the sponsor's last update on 17 Jan 2024. 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 Pakistan. 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. 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?
Results are not available in the source record.
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?
Eligibility Assessment: (time frame: 2-4 weeks). The study lists 6 primary outcomes in all. 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 Jan 2024.