Low Intensity Intervention to Reduce Posttraumatic Stress in People Exposed to Adversity

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614001235695
• Date of registration: 26/11/2014
• Prospective Registration: No
• Primary sponsor: Human Development Research Foundation
• Public title: Low Intensity Intervention to Reduce Posttraumatic Stress in People Exposed to Adversity
• Scientific title: Randomised Controlled Trial of Problem Management Plus versus Enhanced Treatment as Usual to Reduce Posttraumatic Stress in People Exposed to Adversity
• Date of first enrolment: 01/11/2014
• Target sample size: 346
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12614001235695.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

Pakistan

Contacts

• Name: Prof Atif Rahman

• Name: Prof Atif Rahman

Key inclusion & exclusion criteria

Inclusion criteria: Inclusion criteria are GHQ >2 and WHODAS>16. There are no other inclusion criteria.
Exclusion criteria: (a) Imminent suicidal intent, (b) severe mental disorder, (c) severe cognitive impairment.

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Depression;Posttraumatic stress disorder;
Depression
Posttraumatic stress disorder

Mental Health - Anxiety

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 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 a 3-month follow-up assessment, resulting in participation duration of 4.5 months. Therapy is provided by local health workers.

Primary Outcome(s)

Anxiety as measured by mean scores on the Hospital Anxiety and Depression Scale


[Pretreatment (week 1), posttreatment (week 7), 3 Month Follow Up (week 15) ]

Depression as measured by mean scores on the Hospital Anxiety and Depression Scale [Pretreatment (week 1), posttreatment (week 7), 3 Month Follow Up (week 15) ]

Secondary Outcome(s)

Posttraumatic stress disorder as measured by means scores on the Posttraumatic Stress Disorder Checklist[Pretreatment (week 1), posttreatment (week 7), 3 Month Follow Up (week 15) ]

Functioning as measured by means scores on the World Health Organisation Disability Assessment Scale (WHODAS) [Pretreatment (week 1), posttreatment (week 7), 3 Month Follow Up (week 15) ]

Depression as measured by the PHQ-9[Pretreatment (week 1), posttreatment (week 7), follow up (13)]

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

Secondary ID(s)

Nil

Source(s) of Monetary Support

Elhra

Ethics review

Status: Approved
Approval date:
Contact:

Postgraduate Medical Institute