Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621000189820
Ethics application status
Approved
Date submitted
14/11/2020
Date registered
22/02/2021
Date last updated
11/01/2024
Date data sharing statement initially provided
22/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of a Stepped Care Intervention on Anxiety and Depression In Distressed People in Jordan
Scientific title
Randomised Controlled Trial of a Stepped Care Intervention Comprising Doing What Matters and Problem Management Plus versus Doing What Matters on Anxiety and Depression in Jordanians Experiencing Distress
Secondary ID [1] 302794 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 319751 0
Depression 319752 0
Condition category
Condition code
Mental Health 317684 317684 0 0
Anxiety
Mental Health 317685 317685 0 0
Depression
Mental Health 317686 317686 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are two arms to this trial. Arm 1 is the intervention arm, and comprises Stepped Care. Therapy commences with Doing What Matters (DWM), a guided self-management course involving working through an illustrated workbook (including written and audio content) within a 5-week period at a self-paced manner (this workbook is available at: https://www.who.int/publications/i/item/9789240003927). To support use of DWM strategies, participants will be supported by a lay helper who will conduct three phone calls of 15-minutes duration throughout the 5 weeks. Participants who are not distressed following DWM will continue to be assessed but will receive no further assistance. Participants who are distressed at the end of DWM course will be provided with Problem Management Plus (PM+) in a group format (gPM+). PM+ is a program developed by the World Health Organization. PM+ involves once-weekly 120-minute sessions delivered by a facilitator over 5 weeks delivered groups of 8-10 people at a time. DWM will teach participants strategies in mindfulness and acceptance strategies. PM+ will teach the following stress coping strategies: anxiety reduction, problem solving, behavioural activation, and accessing social support. Facilitators will be local non-specialist psychosocial workers trained in Jordan by the authors of DWM and PM+, and will be supplemented by completion of conducting practice groups under supervision. Sessions will be conducted in clinics in Jordan. All participants in the Stepped care condition will also receive Enhanced Treatment as Usual (ETAU), and this involves referral to local psychosocial services for additional assistance. Treatment adherence will be assessed by facilitators monitoring session attendance. Arm 1 participants will receive 10 weeks of intervention (5 weeks of DWM and 5 weeks of PM+ or 5 weeks of DWM and 5 weeks of monitoring) and 52 weeks of follow-up assessment, resulting in a total participation duration of 62 weeks.
Intervention code [1] 319072 0
Behaviour
Intervention code [2] 319073 0
Treatment: Other
Comparator / control treatment
Arm 2 is the control condition. The control arm is a single intervention. The Single Intervention commences with Doing What Matters (DWM) , a guided self-management course involving working through an illustrated workbook (including written and audio content) within a 5-week period at a self-paced manner (this workbook is available at: https://www.who.int/publications/i/item/9789240003927). To support use of DWM strategies, participants will be supported by a lay helper who will conduct three phone calls of 15-minutes duration throughout the 5 weeks. Facilitators will be local non-specialist psychosocial workers trained in Jordan by the authors of DWM and PM+, and will be supplemented by completion of conducting practice groups under supervision. Participants who are distressed at the end of DWM will be provided with Enhanced Treatment as Usual (ETAU), and this involves follow-up referral session to local psychosocial services for additional assistance. The duration of the study for any participant will conclude after a 12-month follow-up assessment, resulting in participation duration of 62 weeks. Arm 2 participants will receive 5 weeks of DWM and 5 weeks of monitoring) and 52 weeks of follow-up assessment, resulting in a total participation duration of 62 weeks.
Control group
Active

Outcomes
Primary outcome [1] 325729 0
Anxiety and depression represent a composite primary outcome, as measured by the Hopkins Symptom Checklist.
Timepoint [1] 325729 0
Pretreatment (week 1), post-DWM (week 7), post-PM+ or ETAU (week 13) primary follow-up (week 25), additional follow-up (week 61).
Secondary outcome [1] 388921 0
Functioning as measured using the WHO Disability Assessment Scale..
Timepoint [1] 388921 0
Pretreatment (week 1), post-DWM (week 7), post-PM+ or ETAU (week 13), 1st follow-up (week 25), and 2nd follow-up (week 61).
Secondary outcome [2] 388922 0
Pretreatment (week 1), post-DWM (week 7), post-PM+ or ETAU (week 13), 1st follow-up (week 25), and 2nd follow-up (week 61).
Timepoint [2] 388922 0
Pretreatment (week 1), post-DWM (week 7), post-PM+ or ETAU (week 13), 1st follow-up (week 25), and 2nd follow-up (week 61).
Secondary outcome [3] 388923 0
Wellbeing as measured by the WHO5
Timepoint [3] 388923 0
Pretreatment (week 1), post-DWM (week 7), post-PM+ or ETAU (week 13), 1st follow-up (week 25), and 2nd follow-up (week 61).
Secondary outcome [4] 430549 0
Health usage as measured by the Client Service Receipt Inventory.
Timepoint [4] 430549 0
Secondary outcome [5] 430550 0
Health usage as measured by the Client Service Receipt Inventory.
Timepoint [5] 430550 0
Pretreatment (week 1), post-DWM (week 7), post-PM+ or ETAU (week 13), 1st follow-up (week 25), and 2nd follow-up (week 61).
Secondary outcome [6] 430551 0
Quality of life as measured by the EURO-QoL-5D-5L.
Timepoint [6] 430551 0
Pretreatment (week 1), post-DWM (week 7), post-PM+ or ETAU (week 13), 1st follow-up (week 25), and 2nd follow-up (week 61).
Secondary outcome [7] 430552 0
Quality of life as measured by the EURO-QoL-5D-5L.
Timepoint [7] 430552 0
Pretreatment (week 1), post-DWM (week 7), post-PM+ or ETAU (week 13), 1st follow-up (week 25), and 2nd follow-up (week 61).
Secondary outcome [8] 430553 0
Perceived agency as measured by the Agency subscale of the State Hope scale.
Timepoint [8] 430553 0
Pretreatment (week 1), post-DWM (week 7), post-PM+ or ETAU (week 13), 1st follow-up (week 25), and 2nd follow-up (week 61).
Secondary outcome [9] 430554 0
Perceived agency as measured by the Agency subscale of the State Hope scale.
Timepoint [9] 430554 0
Pretreatment (week 1), post-DWM (week 7), post-PM+ or ETAU (week 13), 1st follow-up (week 25), and 2nd follow-up (week 61).

Eligibility
Key inclusion criteria
Inclusion criteria are:
(a) Jordanians or refugees residing in Jordan,
(b) aged at least 18 years,
(c) K10 score of at least 6
(d) Literacy in Arabic
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will include
(a) imminent plans of suicide,
(b) psychotic disorders,
(c) severe cognitive impairment,
(d) identification of risk of the person’s safety (e.g. partner violence), or
(e) plans to return to Syria in next 12 months.
(f) No access to a telephone

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be adults indicating moderate distress. Participants wishing to participate will be randomly allocated according to a random numbers system administered by an individual who independent of the study and who works at a site that is independent from the trial centre.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analyses will focus primarily on intent-to-treat analysis. Using SPSS version 24, hierarchical linear mixed models (HLM) will be used to study differential effects of each treatment condition because this method effectively handles missing data by calculating estimates of trajectories. For the follow-up analyses between the two conditions, analyses will focus on linear time effects, treatment conditions, and interactions. Fixed effects parameters will be tested with the Wald test (t-test, p <.05, two-sided) and 95% confidence intervals. Cohen’s (d) effect size was calculated for all analyses. The primary outcome measure will be the HSCL. The primary outcome timepoint will be the 25 week assessment.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/05/2023
Actual
13/07/2023
Date of last participant enrolment
Anticipated
1/01/2024
Actual
18/09/2023
Date of last data collection
Anticipated
1/03/2025
Actual
Sample size
Target
800
Accrual to date
Final
800
Recruitment outside Australia
Country [1] 23101 0
Jordan
State/province [1] 23101 0

Funding & Sponsors
Funding source category [1] 307221 0
Charities/Societies/Foundations
Name [1] 307221 0
ELRHA
Country [1] 307221 0
United Kingdom
Primary sponsor type
University
Name
UNSW Sydney
Address
Sydney
NSW 2052
Country
Australia
Secondary sponsor category [1] 308165 0
None
Name [1] 308165 0
Address [1] 308165 0
Country [1] 308165 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307318 0
University of Jordan Human Research Ethics Committee
Ethics committee address [1] 307318 0
University of Jordan Research Committee, Amman, 11942
Ethics committee country [1] 307318 0
Jordan
Date submitted for ethics approval [1] 307318 0
17/03/2022
Approval date [1] 307318 0
13/06/2022
Ethics approval number [1] 307318 0
PF.22.10

Summary
Brief summary
Although scalable psychosocial programs are effective for most people, they are limited because (a) many people do not respond to programs, and (b) agencies cannot predict who will be responsive. It is not cost-effective to provide more intensive programs to all people with common psychological disorders. Currently, people only receive single programs and many do not respond to these programs. This study will test how a stepped care program can (a) provide scalable programs to all people who require assistance, and (b) offer much-needed programs to those who do not benefit from initial intervention. This framework tests a cost-effective model of care that addresses the psychological needs of most people, as well as those with persistent mental disorders in humanitarian crises. A randomized controlled trial will randomise distressed people in Jordan to one of two conditions. The intervention arm is a stepped care program in which people initially receive a self-help psychosocial program that comprises an illustrated workbook plus support phone calls from helpers (Doing What Matters), and if they are distressed at the completion of this they will additionally receive small-group based behavioural program that teaches skills in reducing emotional disorders (Problem Management Plus). In the comparator condition participants will receive Dong What Matters and if they are still distressed at the completion of the program, they will receive Enhanced Treatment as Usual. Assessments will occur at pretreatment (week 1), post-DWM (week 7), post-PM+ or EUC (week 13) primary follow-up (week 25), additional follow-up (week 61). It is expected that participants who receive the stepped care program will have greater reductions in mental health problems than those who receive the single intervention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106810 0
Prof Richard Bryant
Address 106810 0
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 106810 0
Australia
Phone 106810 0
+61 293853640
Fax 106810 0
+61 2 93853141
Email 106810 0
[email protected]
Contact person for public queries
Name 106811 0
Richard Bryant
Address 106811 0
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 106811 0
Australia
Phone 106811 0
+61 293853640
Fax 106811 0
+61 2 93853141
Email 106811 0
[email protected]
Contact person for scientific queries
Name 106812 0
Richard Bryant
Address 106812 0
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 106812 0
Australia
Phone 106812 0
+61 293853640
Fax 106812 0
+61 2 93853141
Email 106812 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All treatment-related data, assessment data, and related data dictionaries will be available.
When will data be available (start and end dates)?
Data will be available following publication of all study outcomes. There is no end date for when this data will be available.
Available to whom?
Researchers wishing to conduct re-analyses of the data
Available for what types of analyses?
Meta-analyses or re-analyses of subgroups.
How or where can data be obtained?
By emailing the Principal Investigator (email: [email protected]).


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.