- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Meryem Yücel, PhD
- Telefonnummer: 617-353-1181
- E-post: mayucel@bu.edu
Studieorter
-
-
Massachusetts
-
Boston, Massachusetts, Förenta staterna, 02215
- Boston University Center for Life Science & Engineering
-
Kontakt:
- Meryem Yücel, PhD
- Telefonnummer: 617-353-1181
- E-post: mayucel@bu.edu
-
Kontakt:
- Miray Altinkaynak, PhD MPH
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
|
Aktiv 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Feasibility of IAT intervention
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in emotion regulation, measured by the Difficulties in Emotion Regulation Scale (DERS-36)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Meryem Yücel, PhD, BU, Biomedical Engineering, Neurophotonics Center
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- TBD not assigned
Läkemedels- och apparatinformation, studiedokument
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