Low Intensity Intervention to Reduce Depression and Anxiety in Women Exposed to Gender-Based Violence

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616000032459
• Date of registration: 18/01/2016
• Prospective Registration: No
• Primary sponsor: Richard Bryant
• Public title: Low Intensity Intervention to Reduce Depression and Anxiety in Women Exposed to Gender-Based Violence
• Scientific title: Randomised Controlled Trial of Problem Management Plus versus Enhanced Treatment as Usual to Reduce Depression and Anxiety in Women Exposed to Gender-Based Violence
• Date of first enrolment: 15/04/2015
• Target sample size: 490
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12616000032459.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Kenya

Contacts

• Name: Prof Richard Bryant

• Name: Prof Richard Bryant

Key inclusion & exclusion criteria

Inclusion criteria: Women exposed to gender-based violence and indicate significant distress as reflected in scores on GHQ > 2 and impaired functioning reflected in scores on WHODAS > 16
Exclusion criteria: (a) Imminent suicidal intent, (b) severe mental disorder, (c) severe cognitive impairment, (d) acute protection risks, (e) exposure to trauma in last month, (f) male gender, (g) acute protection risks

Age minimum: 18 Years
Age maximum: No limit
Gender: Females

Health Condition(s) or Problem(s) studied

Posttraumatic stress disorder;Depression;Anxiety;
Posttraumatic stress disorder
Depression
Anxiety

Mental Health - Anxiety

Mental Health - Other mental health disorders

Mental Health - Depression

Intervention(s)

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 60 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. Attendance at sessions will be monitored via session attendance records. Adherence to strategies will be monitored by checklists of strategies employed. 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.

Primary Outcome(s)

Anxiety and depression are a composite outcome that are measured by mean score on the General Health Questionnaire [Pretreatment (week 1), posttreatment (week 7), follow up (13) ]

Secondary Outcome(s)

Personalised outcomes as measured by the Psychological Outcomes Profile (PSYCHLOPS) scale [Pretreatment (week 1), posttreatment (week 7), follow up (13)]

Mean scores on the World Health Organisation Disability Assessment Schedule 2.0[Pretreatment (week 1), posttreatment (week 7), follow up (13)]

Posttraumatic stress disorder measured by the PTSD Checklist[Pretreatment (week 1), posttreatment (week 7), follow up (13)]

Health service use as measured by reported access of Nairobi health services[Pretreatment (week 1), follow up (13)]

Stressful life events as measured by the Life Events Checklist[Pretreatment (week 1), follow up (13)]

Secondary ID(s)

Nil

Source(s) of Monetary Support

Grand Challenges Canada

Secondary Sponsor(s)

World Vision Kenya

World Health Organisation

Ethics review

Status: Approved
Approval date:
Contact:

World Health Organisation Ethics Review Committee