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NET with older adults.
NOVO: NET Onderzoek Voor ouderen.



- candidate number14863
- NTR NumberNTR3987
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-mei-2013
- Secondary IDs1201-053 / NL 40757.058.13, P13.009 / OND1352440; Fonds Nuts Ohra / CCMO / CME LUMC
- Public TitleNET with older adults.
NOVO: NET Onderzoek Voor ouderen.
- Scientific TitleTowards a better trauma treatment for older adults: From comparative research to actual implementation.
- ACRONYMIn Dutch: NOVO
- hypothesisThe treatment-effects of Narrative Exposure Rationale: In mental health services older adults represent a growing, but under-investigated population. However, trauma-related psychopathology for older adults represent robust, but often hidden problems. In general, few psychotherapies are specially designed for older adults. This accounts all the more for traumatized older adults. Recently an exposure intervention with narrative elements is developed: Narrative Exposure Therapy or NET. In this research project NET will be evaluated to answer the question if NET is a feasible and effective trauma treatment for older adults.
Hypothesis: Treatment-effects of Narrative Exposure Therapy with older adults are higher in comparison to the treatment-effects of Present Centered Therapy on symptoms of PTSD, on comorbid depressive symptoms, Quality of Life and Attribution of Meaning.
- Healt Condition(s) or Problem(s) studiedPost-Traumatic Stress Disorder (PTSD), Older adults
- Inclusion criteriaOlder Adults from 55 years of age onwards, who fulfill the classification of PTSD (DSM-IV), full criteria of one less Avoidance criterium (CAPS). Diverse trauma-contexts, mostly complex trauma. For patients an individual traumafocused psychotherapy is indicated and patients speak sufficiently Dutch not to need an interpreter.
- Exclusion criteria1. Dependence of abuse of drugs (MINI-Plus, appropriate section);
2. Minimal remittance should be 3 months;
3. Psychotic disorder (MINI-plus, appropriate section);
4. Manic or bipolair disorder (MINI-plus, appropriate section);
5. Serious depressive disorder with suicidal thoughts of psychotic symptoms (MINI-plus appropriate section);
6. Cognitive impairment or cognitive disorder (MMSE <20).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 3-apr-2013
- planned closingdate31-dec-2015
- Target number of participants80
- Interventions1. Narrative Exposure Therapy (NET);
2. Present Centered Therapy (PCT).

11 weekly session of 90 minutes consisting of NET. The control-group receives 11 weekly sessions of PCT : Present Centered Therapy (Schnurr e.a., 2005).
- Primary outcome1. Clinician Administered PTSD Scale (CAPS);
2. Harvard Trauma Questionnaire (HTQ-16).
- Secondary outcome1. Beck Depression Inventory-II (BDI-II);
2. WHO Quality of Life (WHOQOL-Bref);
3. Self-efficacy Scale (SES);
4. Attribution of Meaning (MoW/ZGL);
5. Anger and Aggression (STAS/ZAV);
6. General mental health (BSI-53);
7. Personal explanation model and process-evaluation (short qualitative interview).
- Timepoints1. Pretest;
2. Posttest;
3. Follow-up (4 months after completing the intervention);
4. Instruments: Mentioned under primary and secondary outcomes.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES R. Jongedijk
- CONTACT for SCIENTIFIC QUERIESProf. Dr. R.J. Kleber
- Sponsor/Initiator Foundation Centrum '45
- Funding
(Source(s) of Monetary or Material Support)
Fonds Nuts-Ohra
- PublicationsN/A
- Brief summaryRationale:
In mental health services older adults represent a growing, but under-investigated population. However, trauma-related psychopathology for older adults represent robust, but often hidden problems. In general, few psychotherapies are specially designed for older adults. This accounts all the more for traumatized older adults. Recently an exposure intervention with narrative elements is developed: Narrative Exposure Therapy or NET. In this research project NET will be evaluated to answer the question if NET is a feasible and effective trauma treatment for older adults.

Central question:
Has NET with older adults with PTSD an additional effect on 1. PTSD-symptoms and 2. comorbid depressive symptoms, quality of life and attribution of meaning, compared with an intervention which is focuesed on the present (Present Centered Therapy or PCT).

Objective:
With this study NET will be evaluated in its effects on older adults. The purpose is to show that NET is an effective evidence based individual intervention for older adults with trauma-related psychopathology. Based on this study a treatment protocol and specific out-patient trauma-services for elderly patients will be developed.

Study design:
The study will be a randomized controlled intervention study (RCT / Randomized Controlled Trial), repeated measures design, mixed methods.

Study population:
80 older adults from 55 years of age, with a diagnosis of PTSD, according to the DSM-IV classification (full criteria or sub threshold PTSD), patients of foundation Centrum '45. To be included as a subject, for him/her an individual outpatient trauma-focused psychotherapy has to be indicated and there is no need of assistance by an interpreter.

Intervention:
11 weekly session of 90 minutes consisting of NET. The control-group receives 11 weekly sessions of PCT : Present Centered Therapy (Schnurr e.a., 2005).

Main study parameters/endpoints:
The observed changes in PTSD-symptoms, measures with CAPS and HTQ-16. Secondary outcomes: the observes changes in comorbid depressive symptoms (BDI-II), quality of life (WHOQOL-bref and SES), attribution of meaning (MoW), general mental health (BSI-53), anger/agression (STAS), explanatory model and process-evaluation (short interview).
The participants will be enrolled in the Netherlands.
- Main changes (audit trail)
- RECORD7-mei-2013 - 14-mei-2013


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