Depression Anxiety DisorderEFCT-BCTNCT06892613
EFCT vs. BCT for Depression and Anxiety in Married Couples
A study testing Emotion-Focused Couples Therapy (EFCT) and Behavioral Couples Therapy (BCT) in people with Depression Anxiety Disorder and Anxiety, run by Beykoz University at 1 site in Turkey (Türkiye).
Trial summary
This study compares the effectiveness of Emotion-Focused Couples Therapy (EFCT) and Behavioral Couples Therapy (BCT) in reducing depression and anxiety symptoms in married couples. A total of 150 married couples aged 18-65 will be screened, and 60 couples with high depression and anxiety levels will be selected. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression Anxiety Disorder, Anxiety
- What is being tested?
- Emotion-Focused Couples Therapy (EFCT) and Behavioral Couples Therapy (BCT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 15 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Married couples aged between 18 and 65 years
- Married for at least one year
- No current psychiatric diagnosis or history of psychiatric treatment
- Not receiving any form of psychological therapy at the time of recruitment
- Ability to provide informed consent
- Willingness to participate in all therapy sessions and assessments
Who cannot join
- Current or past psychiatric diagnosis (excluding mild transient conditions)
- Ongoing psychological therapy or psychiatric treatment
- Severe mental health disorders (e.g., schizophrenia, bipolar disorder), Substance abuse or dependency
- Severe medical conditions that may interfere with participation
- Refusal to participate in follow-up assessments
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Beykoz University
Istanbul, Istanbul, 34820
Eda Yılmazer, Phd, +905322575880, edayilmazer@beykoz.edu.tr
Metin Çınaroğlu, Phd, 09053247320, metincinaroglu@gmail.com
About this study
Official title: A Comparison of the Effectiveness of Emotion-Focused Couples Therapy and Behavioral Couples Therapy in Reducing Depression and Anxiety Symptoms in Married Couples
This study compares the effectiveness of Emotion-Focused Couples Therapy (EFCT) and Behavioral Couples Therapy (BCT) in reducing depression and anxiety symptoms in married couples. A total of 150 married couples aged 18-65 will be screened, and 60 couples with high depression and anxiety levels will be selected. These couples will be randomly assigned to one of three groups: EFCT, BCT, or a control group. Therapy sessions will be conducted weekly for 12 weeks, with assessments before therapy, after the 6th and 12th sessions, and at a 3-month follow-up. The study aims to determine which therapy is more effective in improving mental health outcomes in couples.
Read the detailed description
Detailed Description:
This randomized controlled trial (RCT) is designed to compare the effectiveness of Emotion-Focused Couples Therapy (EFCT) and Behavioral Couples Therapy (BCT) in reducing depression and anxiety symptoms among married couples. The study will involve 150 married couples aged between 18 and 65, who have been married for at least one year, have no current psychiatric diagnosis, and are not undergoing any form of psychological therapy at the time of recruitment. Recruitment will be conducted through advertisements, social media platforms, and referrals from community centers and family counseling services in Istanbul.
Study Design:
The study will follow a parallel-group design with a 1:1:1 allocation ratio. After an initial screening process, participants will complete a sociodemographic form and two standardized psychological assessments: the Beck Depression Inventory-II (BDI-II) and the Beck Anxiety Inventory (BAI). Based on the assessment results, 60 couples with high levels of depression and anxiety symptoms will be selected for the intervention phase. A computer-generated randomization process will assign 20 couples to the EFCT group, 20 couples to the BCT group, and 20 couples to a control group that will not receive therapy during the study period.
Intervention Protocol:
The EFCT intervention will consist of 12 weekly therapy sessions, each lasting 50 minutes, facilitated by trained clinical psychologists experienced in EFCT. The therapy will focus on enhancing emotional expression, addressing attachment-related insecurities, and fostering emotional bonding between partners. The EFCT framework will follow the standard intervention model, encompassing the three stages of de-escalation, restructuring of interactions, and consolidation.
The BCT intervention will also include 12 weekly 50-minute sessions, focusing on modifying maladaptive behavioral patterns, improving communication, and developing effective problem-solving skills within the relationship. The BCT approach will be guided by the established protocols emphasizing behavioral exchange, communication training, and cognitive restructuring techniques.
The control group will not receive any therapeutic intervention during the 12-week study period but will be offered counseling sessions after the completion of the study to ensure ethical integrity and participant well-being.
Assessment Timeline and Outcome Measures:
Participants will undergo assessments at four key time points:
Baseline (Pre-Intervention): Before the first therapy session, all couples will complete the BDI-II and BAI.
Mid-Intervention: After the 6th therapy session, the BDI-II and BAI will be administered again to evaluate initial changes in depression and anxiety levels.
Post-Intervention: Upon completion of the 12th therapy session, participants will complete the BDI-II and BAI to measure the immediate effects of the intervention.
Follow-Up: Three months after the final therapy session, couples will complete the BDI-II and BAI to assess the sustainability of the therapeutic outcomes.
Data Collection and Management:
Data will be collected using paper-based forms and subsequently entered into a secure electronic database by research assistants. Double data entry will be implemented to minimize errors. All data will be anonymized, and participants will be assigned unique identification codes to ensure confidentiality. The principal investigator will oversee data management and ensure adherence to the study protocol.
Data Analysis Plan:
Statistical analysis will be conducted using SPSS software (version 28.0). Repeated measures ANOVA will be employed to examine within-group and between-group differences over time, focusing on changes in BDI-II and BAI scores. Post-hoc tests (Bonferroni correction) will be used to identify specific differences between the EFCT, BCT, and control groups at each assessment point. Effect sizes (Cohen's d) will be calculated to determine the magnitude of therapeutic effects. Missing data will be handled using multiple imputation methods to maintain the integrity of the dataset.
Ethical Considerations:
The study has received ethical approval from Üsküdar University (Reference number: 61351342/020-675) on December 29, 2024. All participants will provide written informed consent prior to participation. Confidentiality will be maintained throughout the study, and participants will have the right to withdraw at any time without any consequences. The study adheres to the ethical guidelines outlined in the Declaration of Helsinki.
Clinical Significance:
This study aims to provide empirical evidence on the comparative effectiveness of EFCT and BCT in alleviating depression and anxiety symptoms in married couples. The findings are expected to contribute to the development of evidence-based therapeutic interventions in marital counseling, highlighting the potential benefits of both emotion-focused and behavioral approaches in improving mental health and relationship quality.
- Conditions
- Depression Anxiety Disorder, Anxiety
- Being tested
- Emotion-Focused Couples Therapy (EFCT), Behavioral Couples Therapy (BCT)
- Keywords
- Depression, Anxiety, Emotion-Focused Couples Therapy, Behavioral Couples Therapy, Mental Health, Psychotherapy, Marital Counseling
- Medical subject headings
- Anxiety Disorders, Depression, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotion-Focused Couples Therapy (EFCT)Behavioural
EFCT is a structured approach to couples therapy that focuses on helping partners understand and express their emotions, address attachment insecurities, and strengthen their emotional connection.
Behavioral Couples Therapy (BCT)Behavioural
BCT is a form of therapy that aims to improve relationship satisfaction through behavioral change, communication training, and problem-solving techniques.
| Study group | Role | What they receive |
|---|---|---|
| Emotion-Focused Couples Therapy (EFCT) Group | Experimental | Participants in this group will receive Emotion-Focused Couples Therapy, consisting of 12 weekly 50-minute sessions focused on emotional expression, attachment needs, and improving emotional bonds between partners. Receives: Behavioral: Emotion-Focused Couples Therapy (EFCT) |
| Behavioral Couples Therapy (BCT) Group | Experimental | Participants in this group will receive Behavioral Couples Therapy, consisting of 12 weekly 50-minute sessions focused on modifying maladaptive behaviors, enhancing communication, and developing problem-solving strategies. Receives: Behavioral: Behavioral Couples Therapy (BCT) |
| Control Group | No intervention | Participants in this group will receive no therapeutic intervention during the study period but will be offered therapy after the study is completed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Beck Depression Inventory-II (BDI-II)
The Beck Depression Inventory-II (BDI-II) will be used to measure changes in depression symptoms over time. Scores range from 0 to 63, with higher scores indicating more severe depressive symptoms.
Measured: Baseline, after the 6th session (6 week), after the 12th session (12 week), and at 3-month follow-up (24 week)
The Beck Anxiety Inventory (BAI)
The Beck Anxiety Inventory (BAI) will be used to measure changes in anxiety symptoms over time. Scores range from 0 to 63, with higher scores indicating more severe anxiety symptoms.
Measured: Baseline, after the 6th session (6 week), after the 12th session (12 week), and at 3-month follow-up (24 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start1 Jan 2025
- Primary completion1 Aug 2025 (estimated)
- Study completion15 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression Anxiety DisorderStudies 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
- Participants will be randomly assigned to one of three parallel groups: Emotion-Focused Couples Therapy (EFCT), Behavioral Couples Therapy (BCT), or a control group. Each intervention group will receive 12 weekly therapy sessions, while the control group will receive no intervention during the study period.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beykoz University
- Sponsor type
- University, hospital or other
- Collaborators
- Uskudar University, Istanbul Nisantasi University
- Responsible party
- Principal investigator, Eda Yilmazer, Beykoz University
- Investigators
- Eda Yılmazer, Phd, Principal investigator, Beykoz UniversityMetin Çınaroğlu, Phd, Principal investigator, Istanbul Nisantasi UniversitySelami VArol Ülker, Phd, Principal investigator, Üsküdar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06892613
- Sponsor's protocol ID
- EFCT_BCT_Anxiety_Depression_20
- Acronym
- EFCT-BCT
- Status last verified
- Mar 2025
- First submitted
- 16 Feb 2025
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Effectiveness of Emotion-Focused Couples Therapy and Behavioral Couples Therapy in Reducing Depression and Anxiety Symptoms in Married Couples
- ClinicalTrials.gov ID
- NCT06892613
- Acronym / sponsor ID
- EFCT-BCT / EFCT_BCT_Anxiety_Depression_20
- Conditions
- Depression Anxiety Disorder, Anxiety
- Keywords
- Depression, Anxiety, Emotion-Focused Couples Therapy, Behavioral Couples Therapy, Mental Health, Psychotherapy, Marital Counseling
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Beykoz UniversityUniversity, hospital or other
- Collaborators
- Uskudar University, Istanbul Nisantasi University
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 15 Sep 2025 (estimated)
- First posted
- 25 Mar 2025 (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 compares the effectiveness of Emotion-Focused Couples Therapy (EFCT) and Behavioral Couples Therapy (BCT) in reducing depression and anxiety symptoms in married couples. A total of 150 married couples aged 18-65 will be screened, and 60 couples with high depression and anxiety levels will be selected. These couples will be randomly assigned to one of three groups: EFCT, BCT, or a control group. Therapy sessions will be conducted weekly for 12 weeks, with assessments before therapy, after the 6th and 12th sessions, and at a 3-month follow-up. The study aims to determine which therapy is more effective in improving mental health outcomes in couples.
Detailed description
Detailed Description:
This randomized controlled trial (RCT) is designed to compare the effectiveness of Emotion-Focused Couples Therapy (EFCT) and Behavioral Couples Therapy (BCT) in reducing depression and anxiety symptoms among married couples. The study will involve 150 married couples aged between 18 and 65, who have been married for at least one year, have no current psychiatric diagnosis, and are not undergoing any form of psychological therapy at the time of recruitment. Recruitment will be conducted through advertisements, social media platforms, and referrals from community centers and family counseling services in Istanbul.
Study Design:
The study will follow a parallel-group design with a 1:1:1 allocation ratio. After an initial screening process, participants will complete a sociodemographic form and two standardized psychological assessments: the Beck Depression Inventory-II (BDI-II) and the Beck Anxiety Inventory (BAI). Based on the assessment results, 60 couples with high levels of depression and anxiety symptoms will be selected for the intervention phase. A computer-generated randomization process will assign 20 couples to the EFCT group, 20 couples to the BCT group, and 20 couples to a control group that will not receive therapy during the study period.
Intervention Protocol:
The EFCT intervention will consist of 12 weekly therapy sessions, each lasting 50 minutes, facilitated by trained clinical psychologists experienced in EFCT. The therapy will focus on enhancing emotional expression, addressing attachment-related insecurities, and fostering emotional bonding between partners. The EFCT framework will follow the standard intervention model, encompassing the three stages of de-escalation, restructuring of interactions, and consolidation.
The BCT intervention will also include 12 weekly 50-minute sessions, focusing on modifying maladaptive behavioral patterns, improving communication, and developing effective problem-solving skills within the relationship. The BCT approach will be guided by the established protocols emphasizing behavioral exchange, communication training, and cognitive restructuring techniques.
The control group will not receive any therapeutic intervention during the 12-week study period but will be offered counseling sessions after the completion of the study to ensure ethical integrity and participant well-being.
Assessment Timeline and Outcome Measures:
Participants will undergo assessments at four key time points:
Baseline (Pre-Intervention): Before the first therapy session, all couples will complete the BDI-II and BAI.
Mid-Intervention: After the 6th therapy session, the BDI-II and BAI will be administered again to evaluate initial changes in depression and anxiety levels.
Post-Intervention: Upon completion of the 12th therapy session, participants will complete the BDI-II and BAI to measure the immediate effects of the intervention.
Follow-Up: Three months after the final therapy session, couples will complete the BDI-II and BAI to assess the sustainability of the therapeutic outcomes.
Data Collection and Management:
Data will be collected using paper-based forms and subsequently entered into a secure electronic database by research assistants. Double data entry will be implemented to minimize errors. All data will be anonymized, and participants will be assigned unique identification codes to ensure confidentiality. The principal investigator will oversee data management and ensure adherence to the study protocol.
Data Analysis Plan:
Statistical analysis will be conducted using SPSS software (version 28.0). Repeated measures ANOVA will be employed to examine within-group and between-group differences over time, focusing on changes in BDI-II and BAI scores. Post-hoc tests (Bonferroni correction) will be used to identify specific differences between the EFCT, BCT, and control groups at each assessment point. Effect sizes (Cohen's d) will be calculated to determine the magnitude of therapeutic effects. Missing data will be handled using multiple imputation methods to maintain the integrity of the dataset.
Ethical Considerations:
The study has received ethical approval from Üsküdar University (Reference number: 61351342/020-675) on December 29, 2024. All participants will provide written informed consent prior to participation. Confidentiality will be maintained throughout the study, and participants will have the right to withdraw at any time without any consequences. The study adheres to the ethical guidelines outlined in the Declaration of Helsinki.
Clinical Significance:
This study aims to provide empirical evidence on the comparative effectiveness of EFCT and BCT in alleviating depression and anxiety symptoms in married couples. The findings are expected to contribute to the development of evidence-based therapeutic interventions in marital counseling, highlighting the potential benefits of both emotion-focused and behavioral approaches in improving mental health and relationship quality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to one of three parallel groups: Emotion-Focused Couples Therapy (EFCT), Behavioral Couples Therapy (BCT), or a control group. Each intervention group will receive 12 weekly therapy sessions, while the control group will receive no intervention during the study period.
| Arm | Type | Receives |
|---|---|---|
| Emotion-Focused Couples Therapy (EFCT) Group | Experimental | Behavioral: Emotion-Focused Couples Therapy (EFCT)Participants in this group will receive Emotion-Focused Couples Therapy, consisting of 12 weekly 50-minute sessions focused on emotional expression, attachment needs, and improving emotional bonds between partners. |
| Behavioral Couples Therapy (BCT) Group | Experimental | Behavioral: Behavioral Couples Therapy (BCT)Participants in this group will receive Behavioral Couples Therapy, consisting of 12 weekly 50-minute sessions focused on modifying maladaptive behaviors, enhancing communication, and developing problem-solving strategies. |
| Control Group | No intervention | –Participants in this group will receive no therapeutic intervention during the study period but will be offered therapy after the study is completed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Married couples aged between 18 and 65 years
- Married for at least one year
- No current psychiatric diagnosis or history of psychiatric treatment
- Not receiving any form of psychological therapy at the time of recruitment
- Ability to provide informed consent
Key exclusion criteria (5 listed)
- Current or past psychiatric diagnosis (excluding mild transient conditions)
- Ongoing psychological therapy or psychiatric treatment
- Severe mental health disorders (e.g., schizophrenia, bipolar disorder), Substance abuse or dependency
- Severe medical conditions that may interfere with participation
- Refusal to participate in follow-up assessments
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 |
|---|---|---|
| Emotion-Focused Couples Therapy (EFCT)EFCT is a structured approach to couples therapy that focuses on helping partners understand and express their emotions, address attachment insecurities, and strengthen their emotional connection. | Behavioural | Emotion-Focused Couples Therapy (EFCT) Group |
| Behavioral Couples Therapy (BCT)BCT is a form of therapy that aims to improve relationship satisfaction through behavioral change, communication training, and problem-solving techniques. | Behavioural | Behavioral Couples Therapy (BCT) Group |
Primary outcome
The Beck Depression Inventory-II (BDI-II)
Time frame: Baseline, after the 6th session (6 week), after the 12th session (12 week), and at 3-month follow-up (24 week)
The Beck Depression Inventory-II (BDI-II) will be used to measure changes in depression symptoms over time. Scores range from 0 to 63, with higher scores indicating more severe depressive symptoms.
The Beck Anxiety Inventory (BAI)
Time frame: Baseline, after the 6th session (6 week), after the 12th session (12 week), and at 3-month follow-up (24 week)
The Beck Anxiety Inventory (BAI) will be used to measure changes in anxiety symptoms over time. Scores range from 0 to 63, with higher scores indicating more severe anxiety symptoms.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
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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.
Eda Yılmazer, Phd principal investigator
Beykoz University
Metin Çınaroğlu, Phd principal investigator
Istanbul Nisantasi University
Selami VArol Ülker, Phd principal investigator
Üsküdar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotion-Focused Couples Therapy (EFCT) and Behavioral Couples Therapy (BCT) in people with Depression Anxiety Disorder and Anxiety, run by Beykoz University at 1 site in Turkey (Türkiye).
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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 25 Mar 2025. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eda Yılmazer, Phd (+905322575880, edayilmazer@beykoz.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Beck Depression Inventory-II (BDI-II) (time frame: Baseline, after the 6th session (6 week), after the 12th session (12 week), and at 3-month follow-up (24 week)). The study lists 2 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 25 Mar 2025.