- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07922382
Integrated Attachment Theory
This pilot randomized waitlist-controlled study will evaluate the feasibility and preliminary effects of a 12-week Integrated Attachment Theory (IAT) psychoeducational coaching program in adults ages 18-65 with an insecure attachment pattern identified through study screening.
Eligible participants will be randomized 1:1 to immediate IAT or a 12-week waitlist followed by IAT. The immediate group will complete in-person Boston University assessments before and after IAT; the waitlist group will complete assessments at baseline, after the 12-week waiting period, and after subsequently completing IAT.
The primary objectives are to determine whether the study procedures and intervention are feasible and to estimate the magnitude and variability of pre/post changes. The investigators hypothesize that IAT will be associated with improvement in attachment-related patterns, emotion regulation, interpersonal functioning, and well-being, together with changes in physiological and cortical responses during attachment-related emotion regulation compared with the waitlist period.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Meryem Yücel, PhD
- Numero di telefono: 617-353-1181
- Email: mayucel@bu.edu
Luoghi di studio
-
-
Massachusetts
-
Boston, Massachusetts, Stati Uniti, 02215
- Boston University Center for Life Science & Engineering
-
Contatto:
- Meryem Yücel, PhD
- Numero di telefono: 617-353-1181
- Email: mayucel@bu.edu
-
Contatto:
- Miray Altinkaynak, PhD MPH
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Speak and read English sufficiently to complete study questionnaires and the IAT program
- Meets the PDS attachment-style eligibility criterion for insecure attachment
- Able and willing to attend required in-person Boston University (BU) research visits
- Able and willing, if assigned, to participate in the 12-week remote IAT program.
Exclusion Criteria:
- Self-reported neurological disorder or condition
- Self-reported psychiatric/mental-health disorder
- Patient Health Questionnaire-9 (PHQ-9) total score >14
- Generalized Anxiety Disorder-7 (GAD-7) total score >14
- Failure to meet the PDS attachment-style eligibility criterion
- Inability to complete required study procedures
- A safety concern that makes participation inappropriate.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Immediate Integrated Attachment Theory (IAT)
Participants randomized to this arm will immediately receive the 12 week IAT intervention. |
IAT provides12 consecutive weekly remote Zoom sessions delivered by Personal Development School (PDS). Each session lasts approximately 2.5 hours with about 90 minutes of teaching plus 1 hour of supervised support. Participants will work in small breakout rooms with two participants per room during the support portion. The 12-week curriculum addresses core beliefs, relationship needs, emotional/nervous-system patterns, communication, boundaries, and behaviors. Participants will also complete approximately 10 minutes of daily skills practice/homework. |
|
Comparatore attivo: Waitlist followed by IAT
Participants randomized to this arm will be put on a 12 week waitlist and after will receive the IAT intervention. |
IAT provides12 consecutive weekly remote Zoom sessions delivered by Personal Development School (PDS). Each session lasts approximately 2.5 hours with about 90 minutes of teaching plus 1 hour of supervised support. Participants will work in small breakout rooms with two participants per room during the support portion. The 12-week curriculum addresses core beliefs, relationship needs, emotional/nervous-system patterns, communication, boundaries, and behaviors. Participants will also complete approximately 10 minutes of daily skills practice/homework. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Feasibility of IAT intervention
Lasso di tempo: baseline through 12 weeks
|
Feasibility will be assessed using intervention and study completion. The number and percentage of participants assigned to IAT who complete the 12-week IAT program and the corresponding post-intervention research assessment will be calculated. Higher completion/retention rates will indicate greater feasibility. |
baseline through 12 weeks
|
|
Change in attachment
Lasso di tempo: baseline and 12 weeks
|
Attachment will be assessed using the self-report Personal Development School (PDS) Attachment-Style Questionnaire administered at baseline and again at the post-intervention assessment. The questionnaire characterizes participants' attachment patterns, including secure and insecure attachment styles. Change from baseline to 12 weeks will be evaluated, with movement toward greater attachment security interpreted as improvement. |
baseline and 12 weeks
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in emotion regulation, measured by the Difficulties in Emotion Regulation Scale (DERS-36)
Lasso di tempo: baseline and 12 weeks
|
Emotion regulation will be assessed using the 36-item self-report Difficulties in Emotion Regulation Scale (DERS-36). Items are rated on a 5-point scale from 1 (almost never) to 5 (almost always). The total score ranges from 36 to 180. Higher scores indicate greater difficulties with emotion regulation; therefore, a decrease in score from baseline indicates improvement in emotion regulation. |
baseline and 12 weeks
|
|
Change in interpersonal functioning, measured by the Inventory of Interpersonal Problems-32 (IIP-32)
Lasso di tempo: baseline and 12 weeks
|
Interpersonal functioning will be assessed using the 32-item self-report Inventory of Interpersonal Problems, Short Form (IIP-32). Items are rated from 0 (not at all) to 4 (very much) and assess difficulties across eight interpersonal domains. Higher scores indicate greater interpersonal difficulties; therefore, a decrease from baseline indicates improvement in interpersonal functioning. |
baseline and 12 weeks
|
|
Change in well-being, measured by the WHO-5 Well-Being Index
Lasso di tempo: baseline and 12 weeks
|
Well-being will be assessed using the 5-item self-report World Health Organization 5 (WHO-5) Well-Being Index. Each item is rated from 0 to 5. Raw scores range from 0 to 25 and are multiplied by 4 to yield a score from 0 to 100. Higher scores indicate better well-being; therefore, an increase from baseline indicates improvement. |
baseline and 12 weeks
|
Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Meryem Yücel, PhD, BU, Biomedical Engineering, Neurophotonics Center
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- TBD not assigned
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .