- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07622654
Effect of Emotion-Focused Acceptance and Commitment Therapy on Obsessive-Compulsive Disorder Symptom Severity (ACT-OCD)
The Effect of Emotion-Focused Acceptance and Commitment Therapy on Obsessive-Compulsive Disorder Symptom Severity: A Randomized Controlled Trial
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This randomized controlled trial investigates the efficacy of an Emotion-Focused Acceptance and Commitment Therapy (ACT) protocol in adults diagnosed with Obsessive-Compulsive Disorder (OCD). Participants will be recruited from the psychiatry outpatient clinic of Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi.
Eligible participants will be randomly assigned to one of two arms:
ACT-based group psychotherapy: Structured group therapy targeting emotional awareness, acceptance of emotional experiences, cognitive defusion, present-moment focus, values clarification, and committed action. Groups will consist of 8-10 participants, meeting once weekly for 10-12 sessions of 2 hours each.
Supportive group psychotherapy (active control): Unstructured supportive group therapy aimed at providing emotional support, enhancing coping with stress, and maintaining current functioning. Groups will consist of 8-10 participants, meeting once weekly for 10-12 sessions of 2 hours each.
Assessments will be conducted at baseline and post-treatment using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), Dimensional Obsessive-Compulsive Scale (DOCS), Vancouver Obsessional Compulsive Inventory (VOCI), SF-36 Quality of Life Scale, Acceptance and Action Questionnaire-II (AAQ-II), Hospital Anxiety and Depression Scale (HADS), and Toronto Alexithymia Scale (TAS-20).
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Mehmet Emrah Karadere
- Telefonnummer: 05332651664
- E-post: memrahkaradere@gmail.com
Studiesteder
-
-
Istanbul
-
Istanbul, Istanbul, Tyrkia (Türkiye), 34722
- Rekruttering
- Goztepe Prof. Dr. Suleyman Yalcin City Hospital
-
Ta kontakt med:
- Mehmet Emrah Karadere
- Telefonnummer: 905332651664
- E-post: memrahkaradere@gmail.com
-
Hovedetterforsker:
- Mehmet Emrah Karadere
-
Underetterforsker:
- Kaasım Fatih Yavuz
-
Underetterforsker:
- Beyza Baran Boz
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Diagnosis of Obsessive-Compulsive Disorder according to DSM-5 criteria
- Age between 18-65 years
- Minimum literacy level
- Willingness to participate and providing informed consent
Exclusion Criteria:
- Age over 65 years
- Diagnosis of alcohol or substance use disorder
- Comorbid psychotic disorder or intellectual disability
- Any change in psychiatric treatment (medication or psychotherapy) in the last 3 months
- Comorbid psychiatric disorder that would impair group therapy compliance
- History of cognitive impairment due to dementia, organic brain syndrome or other neurological/organic pathology
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: ACT-Based Group Psychotherapy
Emotion-focused Acceptance and Commitment Therapy (ACT) based structured group psychotherapy targeting emotional awareness, acceptance, cognitive defusion, present-moment focus, values clarification and committed action.
Groups consist of 8-10 participants, meeting once weekly for 10-12 sessions of 2 hours each.
|
Structured group psychotherapy based on ACT principles targeting emotional awareness, acceptance of emotional experiences, cognitive defusion, present-moment focus, values clarification and committed action.
Sessions are conducted face-to-face, once weekly, 2 hours per session, for 10-12 weeks.
|
|
Aktiv komparator: Supportive Group Psychotherapy
Unstructured supportive group psychotherapy aimed at providing emotional support, enhancing coping with stress and maintaining current functioning.
Groups consist of 8-10 participants, meeting once weekly for 10-12 sessions of 2 hours each.
|
Structured group psychotherapy based on ACT principles targeting emotional awareness, acceptance of emotional experiences, cognitive defusion, present-moment focus, values clarification and committed action.
Sessions are conducted face-to-face, once weekly, 2 hours per session, for 10-12 weeks.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Obsessive-Compulsive Symptom Severity
Tidsramme: Baseline and 10-12 weeks (post-treatment)
|
Change in OCD symptom severity measured by Yale-Brown Obsessive Compulsive Scale (Y-BOCS) from baseline to post-treatment.
|
Baseline and 10-12 weeks (post-treatment)
|
|
OCD Symtom Severity- DOCS
Tidsramme: Baseline and 10-12 weeks
|
Change in OCD symptom severity measured by Dimensional Obsessive-Compulsive Scale (DOCS) from baseline to post treatment.
|
Baseline and 10-12 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Mehmet Emrah Karadere, Goztepe Prof Dr Suleyman Yalcın City Hospital
- Hovedetterforsker: Kaasım Fatih Yavuz, Baglamsal Bilimler ve Psikoterapiler Dernegi
- Studieleder: Beyza Baran Boz, Goztepe Prof Dr Suleyman Yalcın City Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2026/0040
- 2025/0040 (Annen identifikator: Goztepe SUEH Clinical Research Ethics Committee)
Plan for individuelle deltakerdata (IPD)
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