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Reducing vulnerability for victimization in depressed patients through emotion-regulation training: a randomized controlled trial.

Reducing vulnerability for victimization in depressed patients through emotion-regulation training: a randomized controlled trial. - ALERT: Anti-victimisation: online emotion-regulation training.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON50172
Enrollment
200
Registered
2016-02-22
Start date
2016-07-06
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Victimisatie (slachtofferschap) Depression mood disorders

Interventions

The experimental intervention will consist of an abbreviated and adapted version of the ER skills training (ERT, a short version of the Affect Regulation Training [ART]) as developed by Berking (200

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: (1) Primary diagnosis of a Major Depressive Disorder according to DSM-IV criteria, or a secondary diagnosis of a Major Depressive Disorder next to a primary anxiety disorder (other than obsessive-compulsive disorder) according to DSM-IV criteria. (2) Indicated for outpatient psychotherapy aimed at a depression or anxiety disorder (3) Having been victim of at least one violent crime (such as a threat, assault or sexual abuse) during the past three years; (4) Access to a computer or tablet with internet connection; (5) Aged 18 years or older.

Exclusion criteria

Exclusion criteria: (1) Psychotic symptoms, according to the DSM-IV, as measured with section L of the M.I.N.I.; (2) Current high risk for suicide requiring intervention; (3) Insufficient understanding of the spoken and written Dutch language; (4) Bipolar disorder, according to section D of the M.I.N.I.; (5) Substance dependency that requires treatment; (6) Obsessive-compulsive disorder, according to the DSM-IV.

Design outcomes

Primary

MeasureTime frame
The primary endpoint is the total number of violent crime occurrences during the three years follow up, as measured with the Integrale Veiligheidsmonitor (IVM).The IVM is developed by the Dutch Central Agency for Statistics, the Ministry of the Interior and Kingdom Relations and the Ministry of Justice. Approximately 65,000 people in the general population are screened yearly with the IVMS to determine national victimization rates. The IVM is a self-report instrument, which is more reliable in measuring victimization than a police report (Hiday, 1999). Other primary outcome measures are depression symptoms (as measured with the IDS-SR) and emotion regulation (as measured with the Difficulties of Emotion Regulation Scale; DERS).

Secondary

MeasureTime frame
The secondary outcome measures are: 1. Subjective safety (Module 3 of the IVM); 2. Depression (Inventory of Depressive Symptoms; IDS-SR and QIDS); 3. Diagnosis of depression and comorbid disorders (Mini-International Neuropsychiatric Interview; MINI); 4. Emotion Dysregulation (Difficulties in ER Scale; DERS); 5. Mood (Visual Analogue Mood Scale; VAMS); 6. Coping (Utrechtse Coping Lijst; UCL) 7. Dysfunctional attitudes (Dysfunctional Attitudes Scale; DAS-A-17); 8. Brooding (Brooding subscale of the Rumination Response Scale; RSS-NL); 9. Locus of control (Mastery scale); 10. Positive affect (PANAS); 11. Psychiatric distress (Brief Symptom Inventory; BSI); 12. Quality of life (EuroQol; EQ-5D); 13. Self-esteem (Self-esteem rating scale; SERS-SF-20); 14. Interpersonal functioning (Inventory of Interpersonal Problems; IIP-64); 15. Direct and indirect costs (Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness; TiC-P); 16. Working alliance (Working Alliance Inventory-Short Form; WAI-SF); 17. Client Satisfaction (Client Satisfaction Questionnaire; CSQ); 18. Personality (NEO-FFI); 19. Posttraumatic Stress symptoms (Posttraumatic Symptoms Diagnostic scale; PDS) 20. Negative Life Events (Brugha) 21. Victimisation during the Covid 19 measures in spring 2020. 22. Psychological complaints due to the Covid 19 measures in spring 2020. Characteristics such as sex, age, level of education, ethnicity, living conditions and area, early victimisation and (sexual) maltreatment in the youth (Childhood Trauma Questionnaire; CTQ-SF), will be used as mediators and moderators.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)