Pathological Affective DependenceImRs-PADNCT06670326
Imagery Rescripting for Pathological Affective Dependence and Intimate Partner Violence
A study testing Imagery Rescripting in people with Pathological Affective Dependence, run by University of Amsterdam at 3 sites in 2 countries.
Trial summary
The goal of this multiple baseline case series study is to evaluate the effectiveness of Imagery Rescripting for Pathological Affective Dependence (PAD) in victims of Intimate Partner Violence (IPV). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Pathological Affective Dependence
- What is being tested?
- Imagery Rescripting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Feb 2025to Feb 2026
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Experience of IPV (from a clinical interview)
- Pathological Affective Dependence scale (PADS - Trait, State). As a prerequisite for PAD treatment and study participation, victims of IPV are required to establish a contact with the anti-violence center or shelters to receive co-assistance. The anti-violence center will take care of his/her physical safety and legal aspects.
Who cannot join
- Comorbidity with the following diagnoses: psychosis, schizophrenia, bipolar disorder (conditions derived from a clinical interview or previous diagnostic reports), dissociative disorders (Dissociative Experience Scale, DES).
- Organic brain disease
- Intelligence Quotient (IQ) < 80
- High risk of self-harm or suicide
- Current substance abuse severe level
- Start of new medication within 2 months before beginning the study (medication used for longer periods can be continued; patients are requested to keep medication stable during the course of the study)
Show all 9Show fewer
- Having received ImRs (either as a stand-alone or embedded in a greater treatment such as cognitive behavior therapy (CBT) or schema therapy) within the last year
- No other evidence-based treatment of MDD is allowed during the study.
- Not able to plan enough time for weekly therapy sessions (45-60 minutes); weekly measurements (estimate of 5 minutes) and other measurements (estimate of 20 minutes); and the qualitative post-treatment interview (estimate of 60 minutes) during the study period.
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Netherlands2 sites
Sterk Huis
Amsterdam, Goirle, Rillaersebaan 75 5053 EA
Lenke Balogh, 06-43828325, LenkeBalogh@sterkhuis.nl
University of Amsterdam
Amsterdam
Arnoud Arntz, Phd, Professor, +31 (0)20 525 6810, A.R.Arntz@uva.nl
Arnold van Emmerik, PhD, +31 (0)20 525 6810, a.a.p.vanemmerik@uva.nl
Italy1 site
Associazione Italiana Di Psicoterapia Cognitiva - Aipc
Bari, Italy, 70125
Maria Grazia Foschino Barbaro, Psychology, +39 351 6208206, aipc.scuola@gmail.com
About this study
Official title: Imagery Rescripting As a Treatment for Pathological Affective Dependence: Helping Victims Break Free from Abusive Relationships
The goal of this multiple baseline case series study is to evaluate the effectiveness of Imagery Rescripting for Pathological Affective Dependence (PAD) in victims of Intimate Partner Violence (IPV). The primary research questions are:
Does Imagery Rescripting reduce PAD and/or commitment to the abusive relationship after separation? Does Imagery Rescripting also reduce traumatic symptoms? Does Imagery Rescripting improve general mental health, self-compassion, and resilience in IPV victims? Participants will undergo a waiting period of 5-9 weeks (to assess time effects without treatment), followed by 4 weekly preparation sessions, 12 weekly Imagery Rescripting sessions, and 1 month of post-treatment.
Throughout the study, participants will rate the severity of PAD and relational commitment on a weekly basis. They will also complete more detailed questionnaires assessing mental health, traumatic symptoms, resilience, and self-compassion before each phase, at 1 month post-treatment, 3 months post-treatment, and during follow-ups at 6 and 12 months.
Read the detailed description
In this multiple baseline case series study, the effectiveness of Imagery Rescripting (ImRs) as a treatment for Pathological Affective Dependence (PAD) in victims of Intimate Partner Violence (IPV) will be evaluated. Eighteen victims of IPV with PAD will be randomized to different waitlist lengths (5-9 weeks), after which they will enter a 4-session preparation phase (4 weeks), followed by 12 weekly sessions of ImRs. Follow-up assessments will take place at 4 weeks, 6 months, and 12 months post-treatment.
The primary outcomes are:
PAD severity, which will be assessed weekly using the Pathological Affective Dependence Scale.
Relational commitment, measured using a validated scale. The hypothesis is that primary outcomes will show greater reductions during the treatment phase compared to the waitlist or preparation phases and will either stabilize or show further improvement post-treatment.
Similarly, secondary outcomes such as general mental health (measured by the Patient Health Questionnaire, PHQ-9), resilience (assessed with the The Brief Resilience Scale (RSb), and self-compassion (assessed with the Self-compassion Scale short (SCs) are expected to show the most significant improvements from pre- to post-treatment, with minimal changes during baseline, preparation, and post-treatment phases.
The results will be analyzed using multilevel analysis, pooling the effects across individual cases. In addition, participants will be interviewed 4 weeks post-treatment to gather qualitative feedback on their experiences with the treatment.
- Conditions
- Pathological Affective Dependence
- Being tested
- Imagery Rescripting
- Keywords
- Imagery Rescripting, Pathological Affective Dependence, Treatment, intimate partner violence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imagery RescriptingBehavioural
Also called ImRs
Experimental: Baseline-Preparation-Imagery Rescripting-Post Treatment Each participant follows this sequence: (1) 5-9 weeks waitlist during which no treatment is offered; (2) 4 weekly preparatory sessions. During these sessions the rationale of ImRs will be explained in more detail and a list of painful (childhood) memories to be addressed with ImRs is to be compiled, based on any further input from the patient; and a case conceptualization is made; (3) 12 sessions (45-60 minutes) of ImRs will be offered to participating patients. The treatment for PAD will be based upon the protocol described by Arntz \& Weertman (1999); (4) After end of active treatment (ImRs) 4 weeks follow during which only weekly assessments are done.
| Study group | Role | What they receive |
|---|---|---|
| Baseline-Preparation-Imagery Rescripting-Post Treatment | Experimental | Each participant follows this sequence: (1) 5-9 weeks waitlist during which no treatment is offered; (2) 4 weekly preparatory sessions. During these sessions the rationale of ImRs will be explained in more detail and a list of painful (childhood) memories to be addressed with ImRs is to be compiled, based on any further input from the patient; and a case conceptualization is made; (3) 12 sessions (45-60 minutes) of ImRs will be offered to participating patients. The ImRs treatment will be based upon the protocol described by Arntz \& Weertman (1999). This protocol can be modified to tailor the needs of this study more specifically. (4) After end of active treatment (ImRs) 4 weeks follow during which only weekly assessments are done. Receives: Behavioral: Imagery Rescripting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Affective Dependence Scale (PADS)
The PADS (Pugliese et al., 2024) is a 17-item Likert-type scale designed to assess both the state and trait manifestations of Pathological Affective Dependence (PAD), particularly focusing on the factors that compel individuals to remain in abusive relationships. These factors include internal conflict, the inability to separate from an abusive partner, and experiences of partner abuse. The scale is administered twice, with instructions tailored to measure both state and trait PAD. Each item is rated on a 5-point Likert scale, where 1 = not at all, 2 = slightly, 3 = sometimes, 4 = often, and 5 = always.
Measured: 22-32 weeks plus 3, 6 and 12 months follow-ups
Relational Commitment (RC)
The seven items of the Relationship Commitment scale (Rusbult, Martz, \& Agnew, 1998) include the following items: for example, "I am committed to maintaining my relationship with my partner"; "I want our relationship to last for a very long time"; "I feel very attached to our relationship". Responses are rated on an 8-point scale ranging from 1 (Do not agree at all) to 8 (Agree completely).
Measured: 22-32 weeks plus 3, 6 and 12 months follow-ups
Secondary outcomes (5)
Patient Health Questionnaire (PHQ-9 and PHQ-15)
Patient Health Questionnaire-15 (PHQ-15) is a 15-item self-report tool to measure somatic symptoms. Items responses ranged from 0 (not at all) to 2 (bothered a lot). The total score is calculated by adding all item responses, and scores of 5, 10, and 15 represent cutpoints for low, medium, and high somatic symptom severity, respectively (Spitzer et al., 1999).
- Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-report tool to measure depression symptoms. Item responses ranged from 0 (not at all) to 3 (nearly every day). The total score is calculated by adding all item responses, and scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe, and severe depression, respectively (Kroenke et al., 2001)
Measured: before baseline, before preparatory sessions, before ImRs treatment, 4 weeks after ImRs treatment, 3, 6 and 12 months follow-ups
Self-compassion Scale short (SCs)
Self-Compassion Scale-Short Form (SCS-SF) is a 12-item tool to measure self-compassion. It is composed of six dimensions, each with two items: Self-Kindness (SK), Self-Judgment (SJ), Common Humanity (CH), Isolation (I), Mindfulness (M), and Over-Identification (OI). Items responses ranged from 1 (almost never) to 5 (almost always). Subscale scores are computed by adding item scores, and a total self-compassion score is calculated by reversing the negative subscale items and then adding all subscale scores. Higher scores correspond to higher self-compassion. The internal consistencies ranged between 0.54 to 0.75, and the total Cronbach's alpha was 0.87 (Raes et al., 2011).
Measured: before baseline, before preparatory sessions, before ImRs treatment, 4 weeks after ImRs treatment, 3, 6 and 12 months follow-ups
Psychological General Well-Being Index (PGWB-S)
Patient Health Questionnaire-15 (PHQ-15) is a 15-item self-report tool to measure somatic symptoms. Items responses ranged from 0 (not at all) to 2 (bothered a lot). The total score is calculated by adding all item responses, and scores of 5, 10, and 15 represent cutpoints for low, medium, and high somatic symptom severity, respectively (Spitzer et al., 1999).
- Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-report tool to measure depression symptoms. Item responses ranged from 0 (not at all) to 3 (nearly every day). The total score is calculated by adding all item responses, and scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe, and severe depression, respectively (Kroenke et al., 2001)
Measured: before baseline, before preparatory sessions, before ImRs treatment, 4 weeks after ImRs treatment, 3, 6 and 12 months follow-ups
The Brief Resilience Scale (RSb)
Brief Resilience Scale (BRS): is a 6-item unidimensional tool to measure individual resilience levels. Three items are positively worded, and three are negatively worded. The total score was calculated by reversing items 2, 4, and 6 and then adding all items. Items responses ranged from 1 (strongly disagree) to 5 (strongly agree). Higher scores correspond to higher resilience. Internal consistency ranges from 0.80 to 0.91 (Smith et al., 2008).
Measured: before baseline, before preparatory sessions, before ImRs treatment, 4 weeks after ImRs treatment, 3, 6 and 12 months follow-ups
Generalized Anxiety Disorder 7-item Scale (GAD-7)
Generalized Anxiety Disorder 7-item Scale (GAD-7) is a 7-item self-report tool to measure anxiety symptoms. Item responses ranged from 0 (not at all) to 3 (nearly every day). The total score is calculated by adding all item responses, and scores of 5, 10, and 15 represent cutpoints for mild, moderate, and severe anxiety, respectively (Spitzer et al., 2006)
Measured: before baseline, before preparatory sessions, before ImRs treatment, 4 weeks after ImRs treatment, 3, 6 and 12 months follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start1 Feb 2025 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pathological Affective DependenceStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Multiple baseline case series design: by randomizing participants to different lengths of waitlist (baseline) and comparing means and slopes of weekly reported Pathological Affective Dependence severity and mental health measures, the effectiveness of the treatment is tested.
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Amsterdam
- Sponsor type
- University, hospital or other
- Collaborators
- VU University of Amsterdam, Stichting Achmea Slachtoffer en Samenleving
- Responsible party
- Principal investigator, Erica Pugliese, University of Amsterdam
- Investigators
- Erica Pugliese, PhD, Principal investigator, University of Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06670326
- Sponsor's protocol ID
- FMG-10908
- Acronym
- ImRs-PAD
- Status last verified
- Oct 2024
- First submitted
- 17 Oct 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: because of privacy regulations individual patient data cannot be shared, unless the European Union (EU) regulations on data protection are guaranteed.
Publications
Pugliese E, Uvelli A, Barbaro MGF, Papa C, Visco-Comandini F, Mancini F, van Emmerik AAP. Imagery Rescripting for Pathological Affective Dependence in Intimate Partner Violence (ImRs-PAD): An In-Person Proof-of-Concept Study. Clin Psychol Psychother. 2026 Sep-Oct;33(5):e70339. doi: 10.1002/cpp.70339.
PubMed 42786889
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imagery Rescripting As a Treatment for Pathological Affective Dependence: Helping Victims Break Free from Abusive Relationships
- ClinicalTrials.gov ID
- NCT06670326
- Acronym / sponsor ID
- ImRs-PAD / FMG-10908
- Conditions
- Pathological Affective Dependence
- Keywords
- Imagery Rescripting, Pathological Affective Dependence, Treatment, intimate partner violence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University of AmsterdamUniversity, hospital or other
- Collaborators
- VU University of Amsterdam, Stichting Achmea Slachtoffer en Samenleving
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 1 Nov 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.
The goal of this multiple baseline case series study is to evaluate the effectiveness of Imagery Rescripting for Pathological Affective Dependence (PAD) in victims of Intimate Partner Violence (IPV). The primary research questions are:
Does Imagery Rescripting reduce PAD and/or commitment to the abusive relationship after separation? Does Imagery Rescripting also reduce traumatic symptoms? Does Imagery Rescripting improve general mental health, self-compassion, and resilience in IPV victims? Participants will undergo a waiting period of 5-9 weeks (to assess time effects without treatment), followed by 4 weekly preparation sessions, 12 weekly Imagery Rescripting sessions, and 1 month of post-treatment.
Throughout the study, participants will rate the severity of PAD and relational commitment on a weekly basis. They will also complete more detailed questionnaires assessing mental health, traumatic symptoms, resilience, and self-compassion before each phase, at 1 month post-treatment, 3 months post-treatment, and during follow-ups at 6 and 12 months.
Detailed description
In this multiple baseline case series study, the effectiveness of Imagery Rescripting (ImRs) as a treatment for Pathological Affective Dependence (PAD) in victims of Intimate Partner Violence (IPV) will be evaluated. Eighteen victims of IPV with PAD will be randomized to different waitlist lengths (5-9 weeks), after which they will enter a 4-session preparation phase (4 weeks), followed by 12 weekly sessions of ImRs. Follow-up assessments will take place at 4 weeks, 6 months, and 12 months post-treatment.
The primary outcomes are:
PAD severity, which will be assessed weekly using the Pathological Affective Dependence Scale.
Relational commitment, measured using a validated scale. The hypothesis is that primary outcomes will show greater reductions during the treatment phase compared to the waitlist or preparation phases and will either stabilize or show further improvement post-treatment.
Similarly, secondary outcomes such as general mental health (measured by the Patient Health Questionnaire, PHQ-9), resilience (assessed with the The Brief Resilience Scale (RSb), and self-compassion (assessed with the Self-compassion Scale short (SCs) are expected to show the most significant improvements from pre- to post-treatment, with minimal changes during baseline, preparation, and post-treatment phases.
The results will be analyzed using multilevel analysis, pooling the effects across individual cases. In addition, participants will be interviewed 4 weeks post-treatment to gather qualitative feedback on their experiences with the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multiple baseline case series design: by randomizing participants to different lengths of waitlist (baseline) and comparing means and slopes of weekly reported Pathological Affective Dependence severity and mental health measures, the effectiveness of the treatment is tested.
| Arm | Type | Receives |
|---|---|---|
| Baseline-Preparation-Imagery Rescripting-Post Treatment | Experimental | Behavioral: Imagery RescriptingEach participant follows this sequence: (1) 5-9 weeks waitlist during which no treatment is offered; (2) 4 weekly preparatory sessions. During these sessions the rationale of ImRs will be explained in more detail and a list of painful (childhood) memories to be addressed with ImRs is to be compiled, based on any further input from the patient; and a case conceptualization is made; (3) 12 sessions (45-60 minutes) of ImRs will be offered to participating patients. The ImRs treatment will be based upon the protocol described by Arntz \& Weertman (1999). This protocol can be modified to tailor the needs of this study more specifically. (4) After end of active treatment (ImRs) 4 weeks follow during which only weekly assessments are done. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Experience of IPV (from a clinical interview)
- Pathological Affective Dependence scale (PADS - Trait, State). As a prerequisite for PAD treatment and study participation, victims of IPV are required to establish a contact with the anti-violence center or shelters to receive co-assistance. The anti-violence center will take care of his/her physical safety and legal aspects.
Key exclusion criteria (9 listed)
- Comorbidity with the following diagnoses: psychosis, schizophrenia, bipolar disorder (conditions derived from a clinical interview or previous diagnostic reports), dissociative disorders (Dissociative Experience Scale, DES).
- Organic brain disease
- Intelligence Quotient (IQ) < 80
- High risk of self-harm or suicide
- Current substance abuse severe level
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 |
|---|---|---|
| Imagery RescriptingAlso: ImRsExperimental: Baseline-Preparation-Imagery Rescripting-Post Treatment Each participant follows this sequence: (1) 5-9 weeks waitlist during which no treatment is offered; (2) 4 weekly preparatory sessions. During these sessions the rationale of ImRs will be explained in more detail and a list of painful (childhood) memories to be addressed with ImRs is to be compiled, based on any further input from the patient; and a case conceptualization is made; (3) 12 sessions (45-60 minutes) of ImRs will be offered to participating patients. The treatment for PAD will be based upon the protocol described by Arntz \& Weertman (1999); (4) After end of active treatment (ImRs) 4 weeks follow during which only weekly assessments are done. | Behavioural | Baseline-Preparation-Imagery Rescripting-Post Treatment |
Primary outcome
Pathological Affective Dependence Scale (PADS)
Time frame: 22-32 weeks plus 3, 6 and 12 months follow-ups
The PADS (Pugliese et al., 2024) is a 17-item Likert-type scale designed to assess both the state and trait manifestations of Pathological Affective Dependence (PAD), particularly focusing on the factors that compel individuals to remain in abusive relationships. These factors include internal conflict, the inability to separate from an abusive partner, and experiences of partner abuse. The scale is administered twice, with instructions tailored to measure both state and trait PAD. Each item is rated on a 5-point Likert scale, where 1 = not at all, 2 = slightly, 3 = sometimes, 4 = often, and 5 = always.
Relational Commitment (RC)
Time frame: 22-32 weeks plus 3, 6 and 12 months follow-ups
The seven items of the Relationship Commitment scale (Rusbult, Martz, \& Agnew, 1998) include the following items: for example, "I am committed to maintaining my relationship with my partner"; "I want our relationship to last for a very long time"; "I feel very attached to our relationship". Responses are rated on an 8-point scale ranging from 1 (Do not agree at all) to 8 (Agree completely).
5 secondary outcomes
Patient Health Questionnaire (PHQ-9 and PHQ-15)
Time frame: before baseline, before preparatory sessions, before ImRs treatment, 4 weeks after ImRs treatment, 3, 6 and 12 months follow-ups
Self-compassion Scale short (SCs)
Time frame: before baseline, before preparatory sessions, before ImRs treatment, 4 weeks after ImRs treatment, 3, 6 and 12 months follow-ups
Psychological General Well-Being Index (PGWB-S)
Time frame: before baseline, before preparatory sessions, before ImRs treatment, 4 weeks after ImRs treatment, 3, 6 and 12 months follow-ups
The Brief Resilience Scale (RSb)
Time frame: before baseline, before preparatory sessions, before ImRs treatment, 4 weeks after ImRs treatment, 3, 6 and 12 months follow-ups
Generalized Anxiety Disorder 7-item Scale (GAD-7)
Time frame: before baseline, before preparatory sessions, before ImRs treatment, 4 weeks after ImRs treatment, 3, 6 and 12 months follow-ups
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 1 Nov 2024.
- Derived from this study: PubMed 42786889Pugliese E, Uvelli A, Barbaro MGF, Papa C, Visco-Comandini F, Mancini F, van Emmerik AAP. Imagery Rescripting for Pathological Affective Dependence in Intimate Partner Violence (ImRs-PAD): An In-Person Proof-of-Concept Study. Clin Psychol Psychother. 2026 Sep-Oct;33(5):e70339. doi: 10.1002/cpp.70339.
- Individual participant dataSharing planned: No. because of privacy regulations individual patient data cannot be shared, unless the European Union (EU) regulations on data protection are guaranteed.
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.
Erica Pugliese, PhD principal investigator
University of Amsterdam
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imagery Rescripting in people with Pathological Affective Dependence, run by University of Amsterdam at 3 sites in 2 countries.
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 2 inclusion and 9 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: opening soon, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands, Italy. 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 Erica Pugliese, PhD (+31 (0)20 525 6810, e.pugliese@uva.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Affective Dependence Scale (PADS) (time frame: 22-32 weeks plus 3, 6 and 12 months follow-ups). 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?
On the ClinicalTrials.gov record for NCT06670326, which also lists 1 linked publication.
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 1 Nov 2024.