Skip to content

Low Intensity Intervention to Reduce Depression and Anxiety in women Exposed to Adversity

Cluster Randomised Controlled Trial of Problem Management Plus versus Enhanced Treatment as Usual to Reduce Depression and Anxiety in women Exposed to Adversity

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000037404
Enrollment
612
Registered
2016-01-19
Start date
2016-01-11
Completion date
2016-08-21
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The rationale of the study is to evaluate the effectiveness and cost-effectiveness of a low intensity intervention to reduce mental health problems in women in low-resources settings. This study compares the relative effectiveness of (a) Group Problem Management Plus, and (b) Enhanced Treatment as Usual. It is hypothesised that Group Problem Management Plus will lead to greater symptom reduction than Enhanced Treatment as Usual.

Interventions

There are two arms to this trial. Arm 1: Group Problem Management Plus. Arm 2: Enhanced Treatment as Usual. Therapy is administered once weekly over 5 weeks in a group format over 3 hours per session. 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 3 months follow-up assessment and resulting in participation duration

There are two arms to this trial. Arm 1: Group Problem Management Plus. Arm 2: Enhanced Treatment as Usual. Therapy is administered once weekly over 5 weeks in a group format over 3 hours per session. 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 3 months follow-up assessment and resulting in participation duration of around 5 months. Therapy is provided by lay health counselors along with community health workers. Fidelity testing of 10-15% sessions will be done in the field.

Sponsors

Human Development Research Foundation
Lead SponsorCharities/Societies/Foundations

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

GHQ >2 and WHODAS>16

Exclusion criteria

(a) Imminent suicidal intent, (b) severe mental disorder, (c) severe cognitive impairment.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 27, 2026