DepressionNCT06252909
Treating Common Mental Disorders in Women in Mozambique by Addressing Intimate Partner Violence in Couples
A study testing Interpersonal Psychotherapy for Couples and Interpersonal Psychotherapy (Individual) in people with Depression and Anxiety, run by New York State Psychiatric Institute.
Trial summary
Adapting mental health treatments to address modifiable interpersonal problems has the potential to improve and sustain outcomes in low-resource settings where treatment gaps persist. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety, PTSD
- What is being tested?
- Interpersonal Psychotherapy for Couples and Interpersonal Psychotherapy (Individual)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 30 Nov 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both partners aged ≥18;
- both partners identify each other as one of (in case of polygamous marriage) their primary sexual partners of the opposite sex;
- partnered for at least 3 months;
- woman screens positive for a CMD using the Mental Wellness Tool developed and validated by our PRIDE team in Mozambique;
- couples have mild to moderate forms of situational IPV (Ongoing Abuse Scale score = 1 or above). See below exclusion criteria for how severity will be determined.;
- both partners desire to maintain the relationship;
- woman identifies marital dispute as the main interpersonal problem area causing CMD symptoms.
Who cannot join
- Any indicators of severe IPV. The determination of severity will be assessed using items (presence or absence) on the Conflict Tactics Scale (CTS). If any couple member answers yes to both of the following items: "I punched or hit my partner with something that could hurt" and "I kicked my partner," couples will be excluded. Couple members who answer yes to any of the following items: "I used a knife or gun on my partner," "I choked my partner," "I slammed my partner against a wall," "I beat up my partner," "I burned or scalded my partner on purpose," will be excluded. Finally, if any couple member reports that a violent behavior was repeated at least six times in a year by their partner or themselves, violence will be considered severe.;
- (2) discrepancy (>2) in reporting of frequency of violence on CTS in overall average scores of the partners or for any single behavior in the scale. For example, if the female partner reports that her male partner slapped her three times, but the male partner reports that he never slapped his female partner, the couple will be excluded for discrepant reporting for the act of slapping.;
- history of violent legal offences;
- male partner has severe CMD symptoms (PHQ-9 score of 20 or above; GAD-7 score of 15 or above; and PCL-C score of 45 or above); and either partner demonstrates/reports
- serious mental illness,
- cognitive impairment,
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- history of mania (Psychosis Screening Questionnaire score = 1),
- hazardous alcohol use (AUDIT score of 8 or above),
- current suicidality,
- not speaking Portuguese,
- feeling unsafe to participate,
- inability to complete the study.
Trial locations and contacts
No sites are listed yet.
About this study
Adapting mental health treatments to address modifiable interpersonal problems has the potential to improve and sustain outcomes in low-resource settings where treatment gaps persist. This K23 Award will prepare the candidate to become an independent investigator with high-impact public health research and expertise in couple-based interventions that address interrelated mental health problems and intimate partner violence in couples by gaining expertise in engagement and treatment of men, adapting an evidence-based treatment for common mental disorders to address IPV in couples, designing and conducting randomized controlled trials with couples, and professional skills development. This work has applicability for low-resource low-income countries and US populations that experience couple-based violence and the mental health treatment gap. With its focus on intimate partners, the intervention also has the potential to benefit health and wellbeing of children.
- Conditions
- Depression, Anxiety, PTSD, Intimate Partner Violence
- Being tested
- Interpersonal Psychotherapy for Couples, Interpersonal Psychotherapy (Individual)
- Medical subject headings
- Depression, Anxiety Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpersonal Psychotherapy for CouplesBehavioural
Interpersonal Psychotherapy for Couples (IPT-C) consists of 8 weekly conjoint sessions. The clinical goals are to "promote resolution of the role dispute via renegotiation of role relations between the marriage partners" and improve common mental disorders in the woman. Like Interpersonal Psychotherapy, IPT-C has an initiation phase (Session 1-2), middle phase (Sessions 3-6), and termination phase (Sessions 7-8).
Interpersonal Psychotherapy (Individual)Behavioural
Interpersonal Psychotherapy (IPT) is an evidence-based treatment to reduce depression and other common mental disorders. It focuses on helping patients resolve interpersonal problems of disagreements, loneliness, life changes, and grief, and/or change their orientation to the problem.
| Study group | Role | What they receive |
|---|---|---|
| Interpersonal Psychotherapy for Couples | Experimental | Not described Receives: Behavioral: Interpersonal Psychotherapy for Couples |
| Interpersonal Psychotherapy (Individual) | Active comparator | Not described Receives: Behavioral: Interpersonal Psychotherapy (Individual) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Client Satisfaction Questionnaire Client Satisfaction Questionnaire - 8 (CSQ-8)
The Client Satisfaction Questionnaire - 8 measures respondents' opinions about services they have received. Responses are based on a four-point scale (ranging from very negative to very positive), but the options differ depending on the item. Scores range from 8 to 32; higher values indicate higher satisfaction. Scores are calculated by summing scores across all items.
Measured: measured at week 8
IPT Fidelity Checklist
The IPT Fidelity Checklist measures provider fidelity to Interpersonal Therapy. Providers are assessed for low (1), moderate (2), or high (3) adherence to each treatment element. A total score is calculated y summing individuals items. The PRIDE team has adapted this Checklist for Interpersonal Counseling, which will be further adapted in the proposed study for couple-based treatment.
Measured: measured up to 8 weeks
Mental Wellness Tool
The Mental Wellness Tool was developed and validated by the PRIDE team in Mozambique to screen for and differentiate cases according to presence or absence of common mental disorders, severe mental illness, substance use disorders, and suicidal risk. Patients are asked three initial questions. If they respond positively to any of the 3 items, they are asked 10 additional items. The Mental Wellness Tool will be used to screen patients for common mental disorders and exclude patients with severe mental illness, substance use disorders, or suicidality. It will additionally be used to track metrics to determine Reach (i.e., number in need).
Measured: measured at pre-treatment and weeks 8, 12, 20, 32
Secondary outcomes (6)
Patient Health Questionnaire - 9 (PHQ-9)
The PHQ-9 is an instrument for screening, diagnosing, monitoring, and measuring severity of depression. Score cut offs for depression are 5 (mild), 10 (moderate), 15 (moderately severe) and 20 (severe).
Measured: measured at pre-treatment and weeks 8, 12, 20, 32
Generalized Anxiety Disorder - 7 (GAD-7)
GAD-7 is a screening instrument with seven items to assess presence and severity of generalized anxiety severity. Scores range from 0 (not at all) to 3 (nearly every day) for a total range of 0 to 21. Score cut off points are 5 (mild), 10 (moderate), 15 (severe) anxiety.
Measured: measured at pre-treatment and weeks 8, 12, 20, 32
PTSD Checklist - Civilian Version (PCL-C)
The PCL-C is a standardized self-report scale for PTSD comprised of 17 items. It uses a 5-point scale where respondents indicate how much they have been bothered by a symptom (1 = Not at All
- 5 = Extremely). Items are totaled for a severity score (range = 17-85; 17-29 = little to no severity; 30-44 = moderate to moderately high severity; 45-85 = high severity).
Measured: measured at pre-treatment and weeks 8, 12, 20, 32
Revised Conflict Tactics Scale
The Revised Conflict Tactics Scale measures physical, psychological, and sexual intimate partner violence. It consists of 39 items are asked twice: once for respondent and once for partner. Item responses gauge frequency and range from "Never" to "20 or more times." It has five subscales: Negotiation, Psychological Aggression, Physical Assault, Injury, and Sexual Coercion.
Measured: measured at pre-treatment and weeks 8, 12, 20, 32
Dyadic Adjustment Scale
The Dyadic Adjustment Scale (32 Likert items) measures relationship functioning and satisfaction. The four subscales include: Dyadic Satisfaction, Dyadic Consensus, Dyadic Cohesion, and Dyadic Affectional Expression. The score range is 1-151. A higher score indicates better adjustment to marriage.
Measured: measured at pre-treatment and weeks 8, 12, 20, 32
Alcohol Use Disorders Identification Test (AUDIT)
The AUDIT is comprised of 10 items that screen for hazardous or dependent drinking levels. Questions range from 0 to 4 with the exception of items 9 and 10 which have three response options and are scored 0, 2, 4. Items are summed. Score cut off points are 8 (hazardous drinking) and 13 women/15 men (alcohol dependence).
Measured: measured at pre-treatment and weeks 8, 12, 20, 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start1 May 2025 (estimated)
- Primary completion15 Sep 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Mootz, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06252909
- Sponsor's protocol ID
- K23MH122661
- Status last verified
- May 2024
- First submitted
- 24 Jan 2024
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Common Mental Disorders in Women in Mozambique by Addressing Intimate Partner Violence in Couples
- ClinicalTrials.gov ID
- NCT06252909
- Acronym / sponsor ID
- K23MH122661
- Conditions
- Depression, Anxiety, PTSD, Intimate Partner Violence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 12 Feb 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.
Adapting mental health treatments to address modifiable interpersonal problems has the potential to improve and sustain outcomes in low-resource settings where treatment gaps persist. This K23 Award will prepare the candidate to become an independent investigator with high-impact public health research and expertise in couple-based interventions that address interrelated mental health problems and intimate partner violence in couples by gaining expertise in engagement and treatment of men, adapting an evidence-based treatment for common mental disorders to address IPV in couples, designing and conducting randomized controlled trials with couples, and professional skills development. This work has applicability for low-resource low-income countries and US populations that experience couple-based violence and the mental health treatment gap. With its focus on intimate partners, the intervention also has the potential to benefit health and wellbeing of children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interpersonal Psychotherapy for Couples | Experimental | Behavioral: Interpersonal Psychotherapy for Couples |
| Interpersonal Psychotherapy (Individual) | Active comparator | Behavioral: Interpersonal Psychotherapy (Individual) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Both partners aged ≥18;
- both partners identify each other as one of (in case of polygamous marriage) their primary sexual partners of the opposite sex;
- partnered for at least 3 months;
- woman screens positive for a CMD using the Mental Wellness Tool developed and validated by our PRIDE team in Mozambique;
- couples have mild to moderate forms of situational IPV (Ongoing Abuse Scale score = 1 or above). See below exclusion criteria for how severity will be determined.;
Key exclusion criteria (12 listed)
- Any indicators of severe IPV. The determination of severity will be assessed using items (presence or absence) on the Conflict Tactics Scale (CTS). If any couple member answers yes to both of the following items: "I punched or hit my partner with something that could hurt" and "I kicked my partner," couples will be excluded. Couple members who answer yes to any of the following items: "I used a knife or gun on my partner," "I choked my partner," "I slammed my partner against a wall," "I beat up my partner," "I burned or scalded my partner on purpose," will be excluded. Finally, if any couple member reports that a violent behavior was repeated at least six times in a year by their partner or themselves, violence will be considered severe.;
- (2) discrepancy (>2) in reporting of frequency of violence on CTS in overall average scores of the partners or for any single behavior in the scale. For example, if the female partner reports that her male partner slapped her three times, but the male partner reports that he never slapped his female partner, the couple will be excluded for discrepant reporting for the act of slapping.;
- history of violent legal offences;
- male partner has severe CMD symptoms (PHQ-9 score of 20 or above; GAD-7 score of 15 or above; and PCL-C score of 45 or above); and either partner demonstrates/reports
- serious mental illness,
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 |
|---|---|---|
| Interpersonal Psychotherapy for CouplesInterpersonal Psychotherapy for Couples (IPT-C) consists of 8 weekly conjoint sessions. The clinical goals are to "promote resolution of the role dispute via renegotiation of role relations between the marriage partners" and improve common mental disorders in the woman. Like Interpersonal Psychotherapy, IPT-C has an initiation phase (Session 1-2), middle phase (Sessions 3-6), and termination phase (Sessions 7-8). | Behavioural | Interpersonal Psychotherapy for Couples |
| Interpersonal Psychotherapy (Individual)Interpersonal Psychotherapy (IPT) is an evidence-based treatment to reduce depression and other common mental disorders. It focuses on helping patients resolve interpersonal problems of disagreements, loneliness, life changes, and grief, and/or change their orientation to the problem. | Behavioural | Interpersonal Psychotherapy (Individual) |
Primary outcome
Client Satisfaction Questionnaire Client Satisfaction Questionnaire - 8 (CSQ-8)
Time frame: measured at week 8
The Client Satisfaction Questionnaire - 8 measures respondents' opinions about services they have received. Responses are based on a four-point scale (ranging from very negative to very positive), but the options differ depending on the item. Scores range from 8 to 32; higher values indicate higher satisfaction. Scores are calculated by summing scores across all items.
IPT Fidelity Checklist
Time frame: measured up to 8 weeks
The IPT Fidelity Checklist measures provider fidelity to Interpersonal Therapy. Providers are assessed for low (1), moderate (2), or high (3) adherence to each treatment element. A total score is calculated y summing individuals items. The PRIDE team has adapted this Checklist for Interpersonal Counseling, which will be further adapted in the proposed study for couple-based treatment.
Mental Wellness Tool
Time frame: measured at pre-treatment and weeks 8, 12, 20, 32
The Mental Wellness Tool was developed and validated by the PRIDE team in Mozambique to screen for and differentiate cases according to presence or absence of common mental disorders, severe mental illness, substance use disorders, and suicidal risk. Patients are asked three initial questions. If they respond positively to any of the 3 items, they are asked 10 additional items. The Mental Wellness Tool will be used to screen patients for common mental disorders and exclude patients with severe mental illness, substance use disorders, or suicidality. It will additionally be used to track metrics to determine Reach (i.e., number in need).
6 secondary outcomes
Patient Health Questionnaire - 9 (PHQ-9)
Time frame: measured at pre-treatment and weeks 8, 12, 20, 32
Generalized Anxiety Disorder - 7 (GAD-7)
Time frame: measured at pre-treatment and weeks 8, 12, 20, 32
PTSD Checklist - Civilian Version (PCL-C)
Time frame: measured at pre-treatment and weeks 8, 12, 20, 32
Revised Conflict Tactics Scale
Time frame: measured at pre-treatment and weeks 8, 12, 20, 32
Dyadic Adjustment Scale
Time frame: measured at pre-treatment and weeks 8, 12, 20, 32
Alcohol Use Disorders Identification Test (AUDIT)
Time frame: measured at pre-treatment and weeks 8, 12, 20, 32
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Interpersonal Psychotherapy for Couples and Interpersonal Psychotherapy (Individual) in people with Depression and Anxiety, run by New York State Psychiatric Institute.
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 7 inclusion and 12 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 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Jennifer Mootz (6467746409, jennifer.mootz@nyspi.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Client Satisfaction Questionnaire Client Satisfaction Questionnaire - 8 (CSQ-8) (time frame: measured at week 8). The study lists 3 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 20 Mar 2025.