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

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614001244695

Enrollment

Registered

2014-11-27

Start date

2014-04-09

Completion date

2014-08-26

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 pilot study is to evaluate the feasibility of conducting a definitive RCT of a low intensity intervention to reduce mental health problems in people in low-resources settings. This study compares the relative efficacy of (a) Problem Management Plus, and (b) Enhanced Treatment as Usual. It is hypothesised that Problem Management Plus will lead to greater symptom reduction than Enhanced Treatment as Usual.

Interventions

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

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 No maximum

Healthy volunteers

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.

Outcome results