Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000494336
Ethics application status
Approved
Date submitted
3/04/2017
Date registered
5/04/2017
Date last updated
31/01/2018
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
None
Universal Trial Number (UTN)
U1111-1195-0340
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

Intervention/exposure
Study type
Interventional
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
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
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

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
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
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
None
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
None
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
None
Phase
Not Applicable
Type of endpoint/s
Efficacy
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
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
24/04/2017
Actual
19/06/2017
Date of last participant enrolment
Anticipated
15/05/2017
Actual
3/07/2017
Date of last data collection
Anticipated
31/03/2018
Actual
Sample size
Target
4
Accrual to date
Final
2
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 296092 0
University
Name [1] 296092 0
Curtin University
Country [1] 296092 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent Street, Bentley WA 6102
Country
Australia
Secondary sponsor category [1] 294989 0
None
Name [1] 294989 0
-
Address [1] 294989 0
-
Country [1] 294989 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297348 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 297348 0
Ethics committee country [1] 297348 0
Australia
Date submitted for ethics approval [1] 297348 0
02/03/2017
Approval date [1] 297348 0
02/05/2017
Ethics approval number [1] 297348 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73778 0
A/Prof Lauren Breen
Address 73778 0
Curtin University, Kent Street, Bentley, Perth, Western Australia 6102
Country 73778 0
Australia
Phone 73778 0
+61424650733
Fax 73778 0
Email 73778 0
[email protected]
Contact person for public queries
Name 73779 0
Michelle Karangoda
Address 73779 0
Curtin University, Kent Street, Bentley, Perth, Western Australia 6102
Country 73779 0
Australia
Phone 73779 0
+61424650733
Fax 73779 0
Email 73779 0
[email protected]
Contact person for scientific queries
Name 73780 0
Michelle Karangoda
Address 73780 0
Curtin University, Kent Street, Bentley, Perth, Western Australia 6102
Country 73780 0
Australia
Phone 73780 0
+61424650733
Fax 73780 0
Email 73780 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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