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Co-delivery of tele trial Behavioural Activation in people in custody with depression: a feasibility Randomised Controlled Trial

Investigating the feasibility of a Tele trial Behavioural Activation program for people in custody with mild to moderate depression

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000346673
Acronym
TBCD
Enrollment
29
Registered
2023-04-03
Start date
2023-11-09
Completion date
2025-02-10
Last updated
2024-07-15

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

Conditions

None listed

Brief summary

People in custody are at high risk of developing depression. Accessing psychological treatments such as Cognitive Behavioural Therapy (CBT) in a prison setting is a particular challenge in part due to difficulties in accessing specialist mental health workers. An alternative treatment, Behavioural Activation (BA), is just as effective as CBT for depression in adults who are not in prison settings. The application of Behavioural Activation may increase access to an effective treatment for people in custody with depression. However, we lack trial data concerning its acceptability and feasibility. This study will establish the feasibility and acceptability of preparing custodial health nurses to deliver BA to improve depression symptoms in people in custody. Findings from the study may provide opportunities for scaling up BA to support people in custody living with depression.

Interventions

A sample of 60 people in custody aged over 18 years or older with presenting symptoms of depression as assessed using the PHQ 9 scale (with a score of 5-14 mild to moderate depression) will participate in the trial. Recruited people in custody will be randomised to receive Behavioural Activation (BA) plus treatment as usual (TAU) or TAU for depression provided by custodial health nurses. Eight custodial health nurses will be recruited from four rural prisons in South Australia. The BA interven

A sample of 60 people in custody aged over 18 years or older with presenting symptoms of depression as assessed using the PHQ 9 scale (with a score of 5-14 mild to moderate depression) will participate in the trial. Recruited people in custody will be randomised to receive Behavioural Activation (BA) plus treatment as usual (TAU) or TAU for depression provided by custodial health nurses. Eight custodial health nurses will be recruited from four rural prisons in South Australia. The BA intervention will involve custodial nurses preparing people in custody to monitor their mood, identify triggers that can impact mood, identify activities that may enhance mood, and enable each participating person in custody to formulate an activity schedule. Next the custodial nurses will provide participants six 1-1 BA conversations with people in custody once a week for six weeks. The custodial nurses will be supervised by experts in BA via a tele health format. Each conversation will last up to 30minutes in duration. The custodial health nurses that join the study will be trained to deliver BA. The training on BA techniques will be based on an academically accredited and established online “Professional Certificate in BA for Depression” program offered by the University of South Australia. The 10-week online training program consists of five modules: (a) the evidence base of BA (b) introduction to BA (c) assessment and mood monitoring (d) functional analysis, and (e) activity scheduling.

Sponsors

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

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
Yes

Inclusion criteria

The study will comprise two groups of participants: Custodial health nurses and people in custody with depressive symptoms. (a) Custodial health nurses Custodial health nurses employed by CALHN who complete training in BA and agree to participate in the study. (b) People in custody that are: (i) Aged 18 years or above. (ii) Receiving a primary health care service by SA health nurses provided by CALHN at any of the four participating prison sites. (iii) Experiencing mild to moderate depressive symptoms as demonstrated with a baseline score of 5-14 (mild to moderate depression) (18) on the PHQ-9 scale. (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) Custodial health nurses Custodial health nurses employed by CALHN who have not completed training in BA Custodial health nurses employed by CALHN who are planning to leave the service within the next twelve months. (b) People in custody We will exclude people in custody who: (i) Have depressive symptoms and achieve a baseline score of 15+ on the PHQ-9 scale or acute depression. These people will be excluded from the study for their safety. (ii) Express suicidal ideation or are at risk of self-harm, suicide, homicide, or present a risk to others. These potential participants will be referred to a general practitioner or mental health professional for support. (iii) Have multiple mental health diagnoses. (iv) Have a Department for Corrections (DCS) Notice of Concern (NOC) and are placed for High-Risk Assessment Team (HRAT) review. (v) Are actively being treated by Mental Health or Forensic Mental Health team. (vi) Have a disorder that impedes effective communication (eg, severe sensory impairment) or experience difficulty communicating effectively in English. (vii) Are unable to provide informed consent to participate in the study.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 6, 2026