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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
A Case Series Evaluation of a Pilot Brief Behavioural Activation Intervention for Pathological Grief
Scientific title
A Case Series Evaluation of a Pilot Brief Behavioural Activation Intervention for Pathological Grief
Secondary ID [1] 291606 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prolonged grief disorder 302716 0
Depression 302717 0
Post-traumatic stress disorder 306404 0
Condition category
Condition code
Mental Health 302258 302258 0 0
Other mental health disorders

Study type
Description of intervention(s) / exposure
This study was approved by the Curtin University Human Research Ethics Committee (approval number: HR2017-0241). This study is also registered as a clinical trial with the Australian New Zealand Clinical Trials Registry (registration number: ACTRN12617000494336p).
Research Design:
In line with goals for feasibility testing of novel treatments, a case series design was employed with two participants to measure symptoms of PGD before, during, and after BATD-R. Participants completed a three-week baseline until stability was established before beginning the intervention.
The participants completed an initial phone screening interview to determine eligibility based on the inclusion/exclusion criteria. Next, participants completed a pre-assessment at the Curtin University Psychology Clinic and then completed week one baseline measures. Week two and three baseline measures were completed remotely and participants received SMS reminders each week. Participants completed the PG-13, BADS-SF, and UGRS at all baseline points, at each weekly treatment session, and at 1-week post-treatment. All other self-report measures were completed at pre-baseline and at 1-week post-treatment.
The treatment protocol and session checklists were based on the BATD revised treatment manual (BATD-R; Lejuez et al. 2011). The protocol was adapted to tailor the treatment rationale for the unique responses in pathological grief and to ensure key elements of the sessions were covered within 6 sessions rather than 10 sessions as outlined in in the BATD-R manual. The treatment comprised six 1.5 hour weekly sessions over six weeks. Although previous studies have shown that one hour BA sessions per week have been effective (e.g. Lejuez et al., 2011; Daughters et al., 2008; Eisma et al., 2015), 1.5 hour sessions were assessed as more feasible to allow time for rapport building, grief story-telling, and completion of weekly measures. The intervention details are outlined below:
Session 1 Psychoeducation about grief, rationale for BATD-R, introduction of daily
monitoring forms
Session 2 Life areas, values, and activities, and daily monitoring
Session 3 Activity selection and ranking and monitoring with activity planning
Session 4 Monitoring with activity planning
Session 5 Contracts and monitoring with activity planning
Session 6 Concept review of key elements, feedback on progress and monitoring with
activity planning

The therapist was a master of clinical psychology student with two years of clinical experience. To assess the integrity of treatment delivery, an adapted version of the BATD-R Adherence Checklists (Lejuez et al., 2011) was completed by the primary researcher at the completion of each treatment session. An independent rater who was familiar with the BATD-R viewed a random sample of 20 percent of video-recorded sessions and rated session adherence. Rater assessment indicated100 percent agreement with the therapist ratings. The therapist also had weekly team meetings with the research team to monitor adherence and obtain feedback on upcoming participant sessions.
Intervention code [1] 297674 0
Comparator / control treatment
No control group
Control group

Primary outcome [1] 301648 0
Prolonged Grief Disorder Scale (PG-13) score
Timepoint [1] 301648 0
Baseline, weekly, post-treatment and follow-up at 3 and 6-months
Primary outcome [2] 301649 0
Changes in activation and avoidance on the Behavioural Activation Scale for Depression-Short Form (BADS-SF)
Timepoint [2] 301649 0
Baseline, weekly, post-treatment and follow-up at 3 and 6-months
Primary outcome [3] 301650 0
Changes in rumination on the Utrecht Grief Rumination Scale (UGRS)
Timepoint [3] 301650 0
Baseline, weekly, post-treatment and follow-up at 3 and 6-months
Secondary outcome [1] 333438 0
Changes in PTSD symptoms on the PCL-17
Timepoint [1] 333438 0
pre-baseline and post-treatment
Secondary outcome [2] 342615 0
Depression, Anxiety and Stress Scale (DASS-21)
Timepoint [2] 342615 0
Pre-baseline and post-treamtnet

Key inclusion criteria
For inclusion, potential participants must meet criteria for PGD specified by Prigerson and colleagues (2009), be 18 years or older, and able to read, write, and understand English. Additionally, participants concurrently taking psychotropic medication must be on a stable dosage for three or more months prior to beginning the study.
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Exclusion criteria are moderate to high risk of suicide (e.g., plan, timeframe, recent self-harm) or a crisis situation in the last 4 weeks (e.g. acute symptoms resulting in hospital admission), receiving concurrent psychotherapy focused on grief symptoms, a history of psychotic symptoms, or alcohol or substance abuse disorders.

Study design
Purpose of the study
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Single group
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Two adults who were bereaved a minimum of six months after the death of a loved one were recruited via Curtin University’s community radio station. This timeframe was chosen since six months post-bereavement is the earliest time period required for a diagnosis of PGD (Prigerson et al., 2009). Inclusion criteria were that participants were over the age of 18 years, and were bereaved by a significant other in the stipulated timeframe.
Graphical presentation and visual inspection of the data is the primary form of analysis for single case research and is a suitable analysis method for preliminary studies into the feasibility and acceptability of novel treatments (Fisher & Wells, 2008). The methodology outlined by Jacobson and Truax (1991) was used to indicate whether participants experienced reliable and clinically significant change. The reliable change index (RCI) was used as an estimate of clinically significant change. This was determined by calculating the magnitude that participants change on each outcome measure from pre-test to post-test and dividing it by the standard error of measurement. A RCI greater than the value of 1.96 was indicative of reliable change. The cutoff for clinically significant change was calculated using the means and standard deviations from normative data in the literature and defined as two standard deviations below the range of the pre-therapy mean (Jacobson & Truax, 1991). Individuals were then classified as “recovered” (both reliable change and clinically significant improvement), “improved” (only reliable change criteria was met), “unchanged” (neither reliable change or clinically significant change was demonstrated), or “deteriorated” (reliable change criteria met but symptom scores increased (Jacobson & Truax, 1991).

Recruitment status
Active, not recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 296092 0
Name [1] 296092 0
Curtin University
Address [1] 296092 0
Kent Street, Bentley WA 6102
Country [1] 296092 0
Primary sponsor type
Curtin University
Kent Street, Bentley WA 6102
Secondary sponsor category [1] 294989 0
Name [1] 294989 0
Address [1] 294989 0
Country [1] 294989 0

Ethics approval
Ethics application status
Ethics committee name [1] 297348 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 297348 0
Kent Street, Bentley WA 6102
Ethics committee country [1] 297348 0
Date submitted for ethics approval [1] 297348 0
Approval date [1] 297348 0
Ethics approval number [1] 297348 0

Brief summary
As Prolonged grief disorder (PGD) is known to persist without appropriate treatment, it is imperative to identify those at risk of PGD and to develop effective treatments. Treatments for PGD thus far are largely based on the cognitive behavioural model and there is a mounting research demonstrating its effectiveness; however, these CBT-based interventions have several components and little is known about which components are essential to alleviate PGD symptomatology (Jordan and Litz, 2014). There is a need to clarify which bereaved individuals are likely to benefit from which types of interventions. Furthermore, given that rumination, avoidance, and disengagement are key maintaining mechanisms of PGD, studying the effects of BA will provide a clearer understanding about the possible underlying maintaining mechanisms underlying post-loss psychopathology. Additionally, many CBT-based grief treatments have required long treatment protocols and while longer protocols of BA have demonstrated preliminary evidence of reducing PGD symptomatology, few studies have investigated whether the same benefits are possible with a briefer BA protocol.
As such, the current study seeks to examine the feasibility of a 6-week intervention of BATD-R among two bereaved individuals with PGD and explore patterns of symptomatic and functional change based upon weekly measures to monitor symptoms and track the hypothesised mechanisms of change. It was hypothesised that: (a) BATD-R will result in pre-post decreases in post-loss psychopathology including PGD, Post-traumatic stress disorder (PTSD), and Major Depressive Disorder (MDD) symptomatology, and (b) activation will be the mechanism of change underlying reductions in rumination, disengagement, and avoidance. If the current 6-week intervention is effective in reducing PGD symptomatology, this may provide a platform for advancing the development and implementation of brief behavioural activation interventions for PGD.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 73778 0
A/Prof Lauren Breen
Address 73778 0
Curtin University, Kent Street, Bentley, Perth, Western Australia 6102
Country 73778 0
Phone 73778 0
Fax 73778 0
Email 73778 0
Contact person for public queries
Name 73779 0
Ms Michelle Karangoda
Address 73779 0
Curtin University, Kent Street, Bentley, Perth, Western Australia 6102
Country 73779 0
Phone 73779 0
Fax 73779 0
Email 73779 0
Contact person for scientific queries
Name 73780 0
Ms Michelle Karangoda
Address 73780 0
Curtin University, Kent Street, Bentley, Perth, Western Australia 6102
Country 73780 0
Phone 73780 0
Fax 73780 0
Email 73780 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary