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Co-delivery of tele trial Behavioural Activation in people experiencing depression and financial distress: a feasibility protocol

Changes in depressive symptoms following a tele trial of Behavioural Activation for people experiencing depression and financial distress

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000377639
Acronym
BAFD
Enrollment
60
Registered
2023-04-14
Start date
2024-09-02
Completion date
2025-06-30
Last updated
2024-07-29

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

Conditions

None listed

Brief summary

Poor financial health and wellbeing are known to affect psychological wellbeing in adults. There is good evidence that financial stress can result in a low mood. Behavioral Activation is known to treat depression in adult patients. Potentially, Behavioral Activation (BA) may have a role to play in treating depression in people experiencing financial distress. We are not aware of any studies that have tested the feasibility and acceptability of BA conjunctively delivered with financial support service care for financially stressed adults with depression. This study will examine the feasibility and acceptability of implementing a BA tele-trial delivered collaboratively with the Financial Wellbeing & Capability Programs – Outback SA (FWCP) financial support service offered by Centacare Catholic Country SA, a not-for-profit organization in South Australia. Methods A sample of 60 FWCP clients aged 18 years or above with symptoms of depression as indicated by the PHQ-9 scores of 5-14 (mild to moderate depression) and eight Financial Capability Workers will be recruited from across six sites in regional, rural, and remote South Australia. Study participants will be randomized to receive Behavioral Activation plus FWCP financial support service care or FWCP financial support service care alone. The Behavioral Activation component will involve 6 sessions of 30-minute duration which will be delivered twice weekly over six weeks. Specific BA techniques that will be applied include the identification of depressed behaviors; analysis of the triggers and consequences of depressed behaviors; monitoring of activities; development of alternative goal-orientated behaviors; scheduling of activities; and the development of alternative behavioral responses to rumination. The Financial Capability Workers will complete a 10-week online training program in BA comprising five modules: (a) the evidence base of BA (b) introduction to BA (c) assessment and mood monitoring (d) functional analysis, and (e) activity scheduling before they can deliver the psychotherapy to their clients. Changes in depression symptoms will be assessed at three-time points: (a) at baseline, at 6 weeks, and 3-month follow-ups. Quality of life will be assessed at two-time points: (a) at baseline and (b) immediately at postintervention after six weeks. Descriptive statistics and thematic analysis will be used to assess feasibility and acceptability. Discussion The findings from the study will inform the design of a full-scale randomized controlled trial to test the effectiveness preparing FCW to deliver BA to people in financial distress who are depressed.

Interventions

A sample of 60 clients in support of a financial support service aged 18 years or above with symptoms of depression as indicated by the PHQ-9 scores of 5-14 (mild to moderate depression) and six Financial Capability Workers (FCW) will be recruited from across six sites in regional, rural, and remote South Australia. Study participants will be randomized to receive Behavioral Activation (BA) plus FWC financial support service care (intervention arm) or FWC financial support service care alone (co

A sample of 60 clients in support of a financial support service aged 18 years or above with symptoms of depression as indicated by the PHQ-9 scores of 5-14 (mild to moderate depression) and six Financial Capability Workers (FCW) will be recruited from across six sites in regional, rural, and remote South Australia. Study participants will be randomized to receive Behavioral Activation (BA) plus FWC financial support service care (intervention arm) or FWC financial support service care alone (comparator). The BA component will involve 6 1-1 sessions of 30-minute duration which will be delivered once a week over six weeks. Specific BA techniques that will be applied include the identification of depressed behaviors; analysis of the triggers and consequences of depressed behaviors; monitoring of activities; development of alternative goal-orientated behaviors; scheduling of activities; and the development of alternative behavioral responses to rumination. The FCW will complete a 10-week online training program in BA comprising five modules: (a) the evidence base of BA (b) introduction to BA (c) assessment and mood monitoring (d) functional analysis, and (e) activity scheduling before they can deliver the psychotherapy to their clients. Competency is assessed by asking online participants to complete three video recorded conversations demonstrating the skills to deliver BA, therefore structuring a session, mood monitoring and activity scheduling. If they demonstrate competency, participants are awarded a University of South Australia Professional Certificate in Behavioral Activation. The online training of FCW will occur three months before delivering the six sessions of BA to the participants. Experts in BA will provide supervision to the FCW via a tele health digital platform. This will involve group supervision and, as appropriate, the BA expert will supervise the FCW delivering BA to a client via a secure video link. The tele health digital platform will be used to provide assurance that the FCW are adhering the BA intervention.

Sponsors

SA/NT Regional Clinical Trial Coordinating Centre (SA/NT RCCC)
Lead SponsorOther

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

The study will comprise two groups of participants: Financial Capability Workers and FWC clients with depressive symptoms. (a) Financial Capability Workers Financial Capability Workers employed by the FWCP who complete training in BA and agree to participate in the study. (b) FWCP clients with mild-to-moderate depressive symptoms as determined using the PHQ-9 scale Adults clients of the FWCP who agree to participate in the study, and: (i) Are aged 18 years or above. (ii) Are receiving a financial service through FWCP at any of the six participating sites. (iii) Are experiencing clinically meaningful depressive symptoms and achieve a baseline score of 5-14 (mild to moderate depression) on the PHQ-9 scale as determined via a telehealth platform by the research nurse employed by the Tele-trial team. (iv) Understand, read, write, and speak English. (v) Provide informed consent. Prior or current use of medication or psychotherapy will not be a precluding factor.

Exclusion criteria

a) Financial Capability Workers Workers will not be invited to participate if they advise us that they intend to leave the service in the next 12 months. b) FWCP Clients FWCP clients with depressive symptoms who achieve a baseline score of 15+ on the PHQ-9 scale will be excluded from the study for their safety. Similarly, the FWCP clients who express suicidal ideation or present a risk to themselves or others will be excluded for their safety as well as that of the Financial Capability Workers. These potential participants who are excluded will be referred to a general practitioner or mental health professional for support. The FWCP clients already receiving antidepressant medication or any other psychotherapies will be excluded from the study to reduce confounding.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026