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Evaluating the outcome of mental health interventions in Chechnya


- candidate number18376
- NTR NumberNTR4689
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-jul-2014
- Secondary IDsMSFOCA-010-10 
- Public TitleEvaluating the outcome of mental health interventions in Chechnya
- Scientific TitleOutcome evalualtion of Mental Health Intervention in Chechnya
- ACRONYMMH Study Chechnya
- hypothesisThe individual counselling intervention will significantly
- Healt Condition(s) or Problem(s) studiedMental health
- Inclusion criteria- age 18 years or older
- capable of providing informed consent for inclusion in the study
- no cognitive, visual or other impairments that would limit ability to participate in the study
-score on Hopkins Symptom Checklist (HSCL-25) screening instrument greater than threshold
- willing/able to return to counselling centre for follow-up
- Exclusion criteria- judged at intake interview to be at acute risk of suicide
- presence of a major psychiatric disorder requiring medication (e.g. psychosis, severe depression or bi-polar disease)
- have been enrolled in Medecins Sans Frontieres' counselling services within the last 6 months
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2014
- planned closingdate30-mrt-2015
- Target number of participants136
- InterventionsIndividual counseling will be provided as per standard Medecins Sans Frontieres protocols. The counsellor will determine with the client what the main problem is they are seeking to address with the counselling. This will be used to determine a counselling focus using pre-determined categories as decribed. The intervention will continue until the counsellor judges, together with the client, that the presenting problem has resolved or improved to the point that counselling is no longer needed.
- Primary outcomeChange in functioning as measured by the adapted Short Form (SF-36) with the additional of locally adapted functioning questions.
- Secondary outcome- Change in symptoms as measured on the HSCL-25
- Change in coping strategies as measured by the Coping Strategy Indicator
- Change in perceived social support as measured by the Social Provisions
- Timepoints- Change in status at 3 and 6 months post-intervention compared with the immediate post-intervention scores
- Trial web site
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES Annick Lenglet
- CONTACT for SCIENTIFIC QUERIESDr. Giovanni Pintaldi
- Sponsor/Initiator Arsten Zonder Grenzen/Médecins Sans Frontières, Chechnya State University , John Hopkins University
- Funding
(Source(s) of Monetary or Material Support)
Arsten Zonder Grenzen/Médecins Sans Frontières
- Publications
- Brief summaryStudy Hypotheses: The counselling intervention will significantly improve the functioning of adult clients to the MSF mental health program in Chechnya who have been affected by years of war and ongoing violence.

Study Design: The study will be a randomized controlled trial of the MSF individual counselling intervention using a stepped wedge design. Follow up will be for a period of 8 months from enrolment.

Inclusion criteria: Participants who present for care to the MSF mental health program will be included if they meet the following inclusion criteria:
• age 18 years or older
• capable of providing informed consent for inclusion in the study
• No cognitive, visual or other impairments that would limit ability to participate in the study
• Score on HSCL-25 screening instrument greater than threshold
• Willing/able to return to counselling centre for follow up

Exclusion criteria: Participants will be excluded from the study if they meet the following criteria:
• judged at intake interview to be at acute risk of suicide
• presence of a major psychiatric disorder requiring medication (e.g. psychosis, severe depression, or bipolar disease)
• have been enrolled in MSF’s counselling services within the last 6 months

Intervention: The individual counselling intervention will be provided as per standard MSF protocols. The counsellor will determine with the client what the main problem is they are seeking to address with the counselling. This will be used to determine a counselling focus using pre-determined categories as described. The intervention will continue until the counsellor judges, together with the client, that the presenting problem has resolved or improved to the point that counselling is no longer needed.
Sample Size: The required sample size is 46 per arm. Planning for an expected drop out and loss to follow up rate of 30%, we will aim to enrol 136 subjects, 68 in each arm.

Primary Outcome Measure:
Change in functioning as measured by the adapted SF-36 with the addition of locally adapted functioning questions

Secondary Outcome Measures
• Change in symptoms as measured on the HSCL-25
• Change in coping strategies as measured by the Coping Strategy Indicator
• Change in perceived social support as measured by the Social Provisions Scale
• Change in status at 3 and 6 months post intervention compared with the immediate post-intervention scores
• Incidence of PTSD in the study population as measured by the Harvard Trauma Questionnaire part 2 (HTQ-2)
• Impact of the intervention on PTSD amongst those identified on entry as meeting the symptom criteria for PTSD on the HTQ-2
• Client rated symptoms and functionality scores as compared to gold standard
• Counsellor’s perception of problem status compared to functioning instruments
- Main changes (audit trail)13-aug-2014: "Please note, the study has been approved by the Ethical Review Board of Médecins Sans Frontières and Chenchya State University." - AB 27-jan-2015: Update:
1. We initiated patient enrollment on 15 November, 2014
2. Up to last week Friday (23 January, 2015), we had enrolled 133 patients (split between two arms of the study)
3. As the initial patient enrollment went faster than we anticipated, we almost completed the originally calculated sample size by last week Friday. We submitted therefore amendments to the MSF Ethical Review Board and the Chechnyan Ethical board on 26 January, requesting to extend the period of enrollment such as to complete 168 persons enrolled (86 in each arm). This newly calculated samples size is based on an increase in the expected non-response rate from 30% to 45%.
- RECORD15-jul-2014 - 4-nov-2015


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