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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Meryem Yücel, PhD
- Numer telefonu: 617-353-1181
- E-mail: mayucel@bu.edu
Lokalizacje studiów
-
-
Massachusetts
-
Boston, Massachusetts, Stany Zjednoczone, 02215
- Boston University Center for Life Science & Engineering
-
Kontakt:
- Meryem Yücel, PhD
- Numer telefonu: 617-353-1181
- E-mail: mayucel@bu.edu
-
Kontakt:
- Miray Altinkaynak, PhD MPH
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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. |
|
Aktywny komparator: 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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Feasibility of IAT intervention
Ramy czasowe: 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
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in emotion regulation, measured by the Difficulties in Emotion Regulation Scale (DERS-36)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
|
Współpracownicy i badacze
Współpracownicy
Śledczy
- Główny śledczy: Meryem Yücel, PhD, BU, Biomedical Engineering, Neurophotonics Center
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- TBD not assigned
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .