Psychosocial intervention for mental health

• Register: ANZCTR
• Last refreshed on: 25 May 2020
• Main ID: ACTRN12618000307202
• Date of registration: 01/03/2018
• Prospective Registration: Yes
• Primary sponsor: Griffith University
• Public title: Psychosocial intervention for mental health
• Scientific title: Psychosocial intervention to improve mental health, social support, and help-seeking behaviours among abused pregnant women: A mixed method study from Nepal
• Date of first enrolment: 06/06/2018
• Target sample size: 140
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12618000307202.aspx
• Study type: Interventional
• Study design: Purpose: Educational / counselling / training; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Nepal

Contacts

• Name: Mrs Diksha Sapkota

• Name: Mrs Diksha Sapkota

Key inclusion & exclusion criteria

Inclusion criteria: Women will be included in the study if they i) are aged 18 years or older; ii) are 24-34 weeks pregnant; iii) have an identified history of ever experiencing DV in their life using the Abuse Assessment Screening (AAS) tool (at least one affirmative response in AAS); iv) can read and understand Nepali language; and v) have access to a telephone.
Exclusion criteria: Women will be excluded from the study if they i) are at risk of ending their life; ii) are displaying severe mental health disorders (psychotic disorders and substance dependence); iii) have severe cognitive impairment (severe intellectual disability or dementia); or iv) have hearing impairment.

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

Health Condition(s) or Problem(s) studied

Mental Health - Other mental health disorders

Mental health;
Mental health

Public Health - Health promotion/education

Intervention(s)

The intervention will consist of
a. A counselling and education session lasting about 30-40 minutes in the ANC clinic. This one time counselling session will be conducted individually. The session will adhere to the key skills of effective counselling and follow the guidelines provided by the WHO for working with women subjected to DV (WHO 2013, 2014). The researcher is a trained counselor and has previous experience of working with victims of DV. All of the counselling session will be delivered by the same person which will contribute to intervention fidelity. The intervention delivery guide has been prepared and it includes instructions for conducting the intervention and sample scripts to facilitate discussion. This is believed to ensure consistency in the intervention delivery. . This guide is not prescriptive, rather indicative and attempts will be made to conduct the session in a natural conversational style responding to the woman’s individual needs. All topics may not be covered in same depth with every single woman as different women may have different needs, however the student researcher will ensure that the key points outlined in intervention delivery guide are covered.
b. An information booklet has been prepared for this study after critical analysis of existing literature. The content of the booklet has been adapted from "A clinical handbook" by WHO for working with victims of domestic violence and a guide of "Problem management Plus" which deals with promoting mental health of those in adversity including domestic violence. An information booklet will consist of information about stressful life events, stress and problems managing technique, safety planning, social support, and contact details of emergency and support services.
c. Telephone su

Primary Outcome(s)

Mental health measured using Hospital Anxiety and Depression scale validated in Nepali. It consist of 14 items and each item is scored in a four-point Likert scale.[One month after the intervention commencement]

Secondary Outcome(s)

Mean self efficacy score measured using Generalized Self Efficacy Scale consisting of 10 items. Each item will be scored on a four point likert scale.[Baseline, 4 weeks after the intervention commencement, 6 weeks postpartum]

Perceived social support measured using 5 item Medical Outcomes Study Social Support Scale where each item will be scored on a 5-point Likert scale.[Baseline, 4 weeks after the intervention commencement, 6 weeks postpartum]

Help seeking behaviors assessed using self constructed questionnaire asking the participants whether they have used community resources related to domestic violence in past 3 months or not.[Baseline, 4 weeks after the intervention commencement, 6 weeks postpartum]

Use of safety behaviors will be assessed using checklist that is adapted from McFarlane et al., 2002 and it has been modified to meet the local context.[Baseline, 4 weeks after the intervention commencement, 6 weeks postpartum]

Secondary ID(s)

Nil

Source(s) of Monetary Support

Griffith University

Ethics review

Status: Approved
Approval date: 13/03/2018
Contact:

Nepal Health Research Council

Status: Approved
Approval date: 01/06/2018
Contact:

BP Koirala Institute of Health Sciences

Status: Approved
Approval date: 07/06/2018
Contact:

Griffith University Human Research Ethics Committee

Results

• Results available: Yes
• Date Posted: 15/05/2020
• Date Completed: 28/01/2019