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ALERT: Reducing vulnerability for victimization in depressed patients through an online emotion-regulation training.


- candidate number24185
- NTR NumberNTR5822
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-apr-2016
- Secondary IDsNL54940.029.15 NWO
- Public TitleALERT: Reducing vulnerability for victimization in depressed patients through an online emotion-regulation training.
- Scientific TitleReducing vulnerability for victimization in depressed patients through an online emotion-regulation training: a randomized controlled trial.
- ACRONYMALERT
- hypothesisDepressed patients have an increased risk of becoming victim of a violent crime, such as assault, sexual abuse or threat. Emotion regulation is assumed to be an underlying mechanism in both victimization and depression. Emotion dysregulation is considered to be a consequence of prior victimization and a unique predictor of future (re)victimization.
Our research project aims to reduce victimization risk in previously victimized, depressed patients, by developing and implementing an online emotion regulation training that is added to Cognitive Behavioral Therapy (CBT). In this online training, patients will gain control of their negative emotions by learning how to use 4 emotion regulation skills:
awareness, acceptance, analysis and modulation of emotions. Patients will be randomly assigned to either CBT or CBT + online emotion regulation training (ERT). The main hypothesis of this project is that the addition of ERT to CBT reduces violent victimization risk significantly as compared to CBT alone. Therefore, we expect patients in the CBT+ERT condition to become victim of a violent crime less frequently than patients in the CBT condition in the follow-up period of three years.
Therefore, patients in the intervention group will demonstrate a lower frequency of victimization in the follow-up period of 36 months compared to patients in the control group.
- Healt Condition(s) or Problem(s) studiedDepression, Victimization, Emotion regulation problems
- Inclusion criteria(1) Primary diagnosis of a Major Depressive Disorder according to DSM-IV criteria;
(2) Indicated for outpatient CBT treatment;
(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(1) Psychotic symptoms, according to the DSM-IV;
(2) Current high risk for suicide requiring intervention;
(3) Insufficient understanding of the spoken and written Dutch language;
(4) Bipolar disorder;
(5) Substance dependency that requires treatment.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2016
- planned closingdate1-nov-2019
- Target number of participants150
- InterventionsIntervention: Online Emotion Regulation Training. ERT consists of 6 online sessions and online guidance by a therapist via e-mail.
Control intervention: regular Cognitive Behavioral Therapy.
- Primary outcomeVictimization, as measured with the Integrale Veiligheidsmonitor (IVM; self-report questionnaire).
Time-points: Baseline, and 12, 24 and 36 months after baseline.
- Secondary outcome1. Subjective safety (Module 3 of the IVM);
Time points: 0, 12, 24, 36 months
2. Depression (Inventory of Depressive Symptoms; IDS-SR and QIDS);
Time points: 0, 6, 12, 24, 36 months and 8 & 14 weeks.
3. Presence of depression and comorbid disorders (Mini-International Neuropsychiatric Interview; MINI);
Time points: 0 and 12 months
4. Emotion Dysregulation (Difficulties in Emotion Regulation Scale; DERS);
Time points:0, 6, 12, 24, 36 months and 8 & 14 weeks.
5. Mood (Visual Analogue Mood Scale; VAMS);
Time points:0, 6, 12, 24, 36 months and 8 & 14 weeks.
6. PTSD symptoms (Posttraumatic Diagnostic Scale; PDS);
Time points: 0 and 6 months.
7. Coping (Utrechtse Coping Lijst; UCL; two subscales)
Time points:0 and 12 months
8. Dysfunctional attitudes (Dysfunctional Attitudes Scale; DAS-A-17);
Time points: 0 months, 8 weeks, 14 weeks, 6 months and 12 months
9. Brooding (Brooding subscale of the Rumination Response Scale; RSS-NL);
Time points: 0 months, 8 weeks, 14 weeks, 6 months and 12 months
10. Locus of control (Mastery scale);
Time points: 0 months, 8 weeks, 14 weeks, 6 months and 12 months
11. Positive affect (PANAS);
Time points: 0 months, 8 weeks, 14 weeks, 6 months and 12 months
12. Psychiatric distress (Brief Symptom Inventory; BSI);
Time points:0 and 6 months
13. Quality of life (EuroQol; EQ-5D);
Time points: 0, 6 and 12 months
14. Self-esteem (Self-esteem rating scale; SERS-SF-20);
Time points: 0 months
15. Interpersonal functioning (Inventory of Interpersonal Problems; IIP-64);
Time points: 0 and 12 months
16. Direct and indirect costs (Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness; TiC-P);
Time points: 0, 6 and 12 months
17. Working alliance (Working Alliance Inventory-Short Form; WAI-SF);
Time points: 14 weeks
18. Client Satisfaction (Client Satisfaction Questionnaire; CSQ);
Time points: 14 weeks
19. Negative life events (Brugha);
0 and 12 months
20. Personality (NEO Five Factor Inventory; NEO-FFI). Time points: 8 weeks
21. Alliance with online treatment (Technical Alliance Inventory; TAI)
Time points: intervention group only, after last session.
22. Satisfaction with online platform and treatment (System Usability Scale; SUS).
Time points: intervention group only, after last session.
- TimepointsT0: Baseline (0 months)
T1: 8 weeks after start treatment
T2: 14 weeks after start treatment
T3: 6 months after baseline
T4: 12 months after baseline
T5: 24 months after baseline
T6: 36 months after baseline
- Trial web site-
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. Carolien Christ
- CONTACT for SCIENTIFIC QUERIESDr. M.J. Kikkert
- Sponsor/Initiator GGZinGeest, Arkin Institute for Mental Health
- Funding
(Source(s) of Monetary or Material Support)
NWO
- Publications
- Brief summaryDepressed patients have a high risk of being violently victimized. This research project aims to examine the (cost-)effectiveness of an online emotion regulation training added to Cognitive-Behavioral Therapy in reducing victimization risk in previously victimized, depressed patients.
- Main changes (audit trail)
- RECORD4-apr-2016 - 22-jun-2016


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