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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12614001244695 |
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Date of registration:
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27/11/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Low Intensity Intervention to Reduce Depression and Anxiety in People Exposed to Adversity
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Scientific title:
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Exploratory Randomised Controlled Trial of Problem Management Plus versus Enhanced Treatment as Usual to Reduce Depression and Anxiety in People Exposed to Adversity |
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Date of first enrolment:
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09/04/2014 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://anzctr.org.au/ACTRN12614001244695.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
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Phase:
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Not Applicable
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Countries of recruitment
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Pakistan
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Contacts
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Name:
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Prof Atif Rahman
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Address:
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Institute of Psychology, Health and Society
University of Liverpool
Waterhouse Building, Block B, Brownlow Street,
Liverpool L69 3GL
United Kingdom |
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Telephone:
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+44(0)151 252 5509 |
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Email:
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Atif.Rahman@liverpool.ac.uk |
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Affiliation:
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Name:
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Prof Atif Rahman
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Address:
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Institute of Psychology, Health and Society
University of Liverpool
Waterhouse Building, Block B, Brownlow Street,
Liverpool L69 3GL
United Kingdom |
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Telephone:
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+44(0)151 252 5509 |
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Email:
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Atif.Rahman@liverpool.ac.uk |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: GHQ >1 and WHODAS>16
Exclusion criteria: (a) Imminent suicidal intent, (b) severe mental disorder, (c) severe cognitive impairment, (d) acute protections risks (e) exposure to trauma in last month.
Age minimum:
18 Years
Age maximum:
No limit
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Mental Health - Depression
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Mental Health - Anxiety
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Posttraumatic Stress Disorder;Depression;
Posttraumatic Stress Disorder
Depression
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Intervention(s)
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There are two arms to this trial. Arm 1: Problem Management Plus. Arm 2: Enhanced Treatment as Usual. Therapy is administered once-weekly over
5 weeks on an individual 90 minute basis. Problem Management Plus includes skills in identifying emotional and practical problems that can be managed and strategies to reduce and cope with these problems. The duration of the study for any participant will conclude after immediate post-trial follow-up assessment, resulting in participation duration of 1.5 months. Therapy is provided by local health workers.
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Primary Outcome(s)
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Anxiety and depression are a composite outcome that are measured by mean score on the General Health Questionnaire[Pretreatment (week 1), posttreatment (week 7)]
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Secondary Outcome(s)
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Mean scores on the Posttraumatic Stress Disorder Checklist[Pretreatment (week 1), posttreatment (week 7)]
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Mean scores on the World Health Organization Disability Assessment Schedule 2.0[Pretreatment (week 1), posttreatment (week 7)]
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Source(s) of Monetary Support
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Office of US Foreign Disaster Assistance (OFDA)
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Ethics review
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Status: Approved
Approval date:
Contact:
World Health Organisation Ethics Review Committee
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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