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Trial registered on ANZCTR


Registration number
ACTRN12613001270707
Ethics application status
Approved
Date submitted
25/09/2013
Date registered
18/11/2013
Date last updated
19/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of Metacognitive Therapy for Prolonged Grief Disorder: A Randomised Control Trial.
Scientific title
Randomised controlled trial to measure the efficacy of a metacognitive based treatment for adults with prolonged grief
Secondary ID [1] 283201 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prolonged Grief 290060 0
Condition category
Condition code
Mental Health 290435 290435 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Metacognitive Group Therapy program targets maladaptive coping strategies by eliminating worry/rumination, maladaptive attention strategies, and enhancing metacognitive flexibility, which in turn allows natural processing and normal cognitions to occur. The manual comprises three components: engagement in therapy, metacognitive therapy, and maintenance (Rees & van Koesveld, 2009). Each of the 10 modules of the manual will be reviewed and modified by Associate Professor Clare Rees, Dr Moira O’Connor, Dr Lauren Breen, and I to produce a MCT program for PGD. Chambless and Ollendick (2001) argue treatment manulisation is important in evaluating the effects of a specific treatment, as it allows treatment fidelity assessment and an operational definition of the treatment.
The MCT group intervention will be delivered to the intervention group (groups of no less than 10 participants) face-to-face once a week for 2 hours over 6 weeks. Each group session will contain a module overview, the key message, and materials needed. Participants will be asked to complete homework activities between sessions. Participant attendance will be recorded, to certify treatment is received in its entirety, ensuring internal validity. Each group session will be run at the School of Psychology and Speech Pathology (Curtin University), or a more geographically appropriate community centre if required. Refreshments will be provided. The chief investigator and psychology graduate trainee will run the intervention. A program implementation effectiveness checklist will be completed by the chief investigator and graduate psychology student at completion of each session, to control for protocol adherence. Clinical supervision will be provided by Associate Professor Clare Rees with a minimum of 10% of session videotapes checked for adherence to the MCT protocol.
Intervention code [1] 287924 0
Treatment: Other
Comparator / control treatment
A randomised experimental pre-test/post-test control group design with a three-month and six month follow-up for the intervention group. The wait-list control group will be offered MCT (via Curtin’s Adult Psychology Clinic) following the post-test, to ensure they also benefit from their participation in the study. Therapeutic assistance will not be given to the wait-list group throughout the duration of the study. However, wait-list groups will receive a monthly phone call or email to ensure waiting for treatment is not detrimental and that they remain a part of the study. Wait-list participants demonstrating a need for immediate intervention will be withdrawn from the study and provided referral information (e.g., Crisis Care or Lifeline).
Control group
Active

Outcomes
Primary outcome [1] 290462 0
Prolonged Grief Disorder Scale (PG-13)
Timepoint [1] 290462 0
Baseline, post-intervention, 3-month follow-up and 6-month follow-up.
Primary outcome [2] 290463 0
Depression Anxiety Stress Scales-21
Timepoint [2] 290463 0
Baseline, post-intervention, 3-month follow-up and 6-month follow-up.
Primary outcome [3] 290464 0
The Metacognitions Questionnaire-30
Timepoint [3] 290464 0
Baseline, post-intervention, 3-month follow-up and 6-month follow-up.
Secondary outcome [1] 304560 0
The Quality of Life Enjoyment and Satisfaction Questionnaire – 18
Timepoint [1] 304560 0
Baseline, post-intervention, 3-month follow-up and 6-month follow-up.

Eligibility
Key inclusion criteria
Participant inclusion criteria will be: 1) provision of written informed consent; 2) intense symptoms of grief or PGD (as determined by PG-13) 6 months post the loss of a significant other; 3) if taking medication (namely, antidepressants or other mood stabilisers), the medication must be stable for one month prior to baseline assessment. Participants need to remain on the same dosage and medication throughout the treatment period including follow-up.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participant exclusion criteria will be: 1) a high suicidal risk as measured by the suicidality section of the MINI (Sheehan et al., 1997); 2) participants currently undergoing other psychological treatment; and 3) a pre-existing psychiatric (excluding: anxiety & depression) or neurological history, according to the DSMIV-TR diagnostic criteria, as measured by the SCID. Participants that do not meet the inclusion criteria/or meet the exclusion criteria will be excluded from the study and will be provided referral information (such as Lifeline or Crisis Care), or for those identified with high suicidality we will consult with their psychiatrist or local general practitioner.

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 purposively recruited through volunteer sampling. Following recruitment, phone calls will be conducted by the psychology graduate trainee to discuss the nature of the study, its purpose and the commitment required. An information letter will be provided and informed consent will be obtained for participation in the study prior to commencement of the intervention. Participants will then be screened for clinical disorders and suicidality by a psychology graduate trainee using the SCID and the MINI (at a time and place convenient to the participant). The baseline measures will then be posted to the eligible participants (completion taking approximately 10 minutes each) and returned in a supplied prepaid envelope. Following baseline measures all participants will be randomly allocated to either a treatment or control group via central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Saghaei’s (2004) Random Allocation software version 1.0, which generates randomised number lists will be used to ensure group equivalence.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
All participants will receive the same group intervention at different times (the waitlist-control group will be offered the same intervention as the intervention group following the post-test).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
1. The intervention group will report significantly greater pre-post decreases in PGD symptomatology, metacognitions, rumination, depression, anxiety and stress, compared to the wait-list group.
2. The intervention group will report a significantly greater pre-post increase in quality of life, compared to the wait-list group
3. For the intervention group, post-intervention changes in PGD symptomatology, metacognitions, rumination, depression, anxiety, stress and quality of life will be maintained at the 3- and 6-month follow-up.
4. Symptom change in the intervention group will be mediated by reductions in metacognition and rumination scores.
5. The intervention group will report MCGT to be appropriate, acceptable and useful.

A Generalised Linear Mixed Model (GLMM) will be used to test H1 and H2. The GLMM is ‘generalised’ in the sense that it can handle outcome variables with markedly non-normal distributions; GLMM is ‘mixed’ in the sense that it includes both random and fixed effects. The present GLMM includes one categorical random effect (participant), one categorical fixed effect (group: intervention, control), one ordinal fixed effect (time: pre-test, post-test, 3-month follow-up, 6-month follow-up), and the Group x Time interaction. A second GLMM will be developed to test H3. This GLMM will include one categorical random effect (participant) and one ordinal fixed effect (time: pre-test, post-test, 3-month follow-up, 6-month follow-up) will be implemented through SPSS’s (Version 22) GENLINMIXED procedure. In order to optimise the likelihood of convergence, a separate GLMM analysis will be run for each of the outcome measures (PG-13, CBI, DASS, RTQ, UGRS, MCQ-30, Q-LES-Q-18). Analysing each outcome independently of the others will inflate the family-wise error rate and the per-test alpha will therefore need to be corrected to control the inflation. In order to conserve statistical power, the alpha correction will be applied within groups of conceptually related outcomes rather than across the entire set of outcomes.
GLMM will assume a normal probability distribution for the outcome and link it to the fixed effects (group, time, group*time) with an identity function [64]. If the outcome does not have a normal distribution, then the parameter estimates of the covariance matrix will be computed with robust statistics. In order to make the model robust to violations of sphericity, the covariance matrix will be changed from the default of compound symmetry to autoregressive. Compared to the traditional statistical procedures for analysing behavioural change (e.g., repeated measures ANOVA), GLMM is less sensitive to participant attrition, does not rely on participants providing data at every assessment point, can deal with unequally spaced data collection points, is robust to unequal group sizes, does not require equal variances at each time point, does not require equal covariance between all pairs of time points (i.e., sphericity), and is able to account for correlations among repeated measurements [64]. The mediation effects predicted in H4 will be tested by estimating standardised path estimates and standard errors for the mediation pathways with a bootstrapping procedure based on 1000 draws as implemented by Mplus (Version 5.2). Descriptive statistics will be used to analyse the quantitative responses of the Program Satisfaction Questionnaire, whilst the qualitative responses to each question will be summarised.



Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/02/2014
Actual
2/04/2014
Date of last participant enrolment
Anticipated
Actual
3/11/2014
Date of last data collection
Anticipated
Actual
29/06/2015
Sample size
Target
50
Accrual to date
Final
22
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 7379 0
6102 - Bentley

Funding & Sponsors
Funding source category [1] 288035 0
University
Name [1] 288035 0
Curtin University
Country [1] 288035 0
Australia
Primary sponsor type
Individual
Name
Dr Moira O'Connor
Address
Curtin University
Kent Street, Bentley,
Perth Western Australia 6102
Country
Australia
Secondary sponsor category [1] 286791 0
Individual
Name [1] 286791 0
Associate Professor Clare Rees
Address [1] 286791 0
Curtin University
Kent Street, Bentley
Perth Western Australia 6102
Country [1] 286791 0
Australia
Secondary sponsor category [2] 286792 0
Individual
Name [2] 286792 0
Dr Lauren Breen
Address [2] 286792 0
Curtin University
Kent Street, Bentley,
Perth Western Australia 6102
Country [2] 286792 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289959 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 289959 0
Ethics committee country [1] 289959 0
Australia
Date submitted for ethics approval [1] 289959 0
Approval date [1] 289959 0
19/03/2013
Ethics approval number [1] 289959 0
HR41/2013

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

Contacts
Principal investigator
Name 42862 0
Dr Moira O'Connor
Address 42862 0
Curtin University
Kent Street, Bentley
Perth Western Australia 6102
Country 42862 0
Australia
Phone 42862 0
(+618) 9266 1763
Fax 42862 0
Email 42862 0
m.oconnor@curtin.edu.au
Contact person for public queries
Name 42863 0
Moira O'Connor
Address 42863 0
Curtin University
Kent Street, Bentley,
Perth Western Australia 6102
Country 42863 0
Australia
Phone 42863 0
(+618) 9266 1763
Fax 42863 0
Email 42863 0
m.oconnor@curtin.edu.au
Contact person for scientific queries
Name 42864 0
Clare Rees
Address 42864 0
Curtin University
Kent Street, Bentley,
Perth Western Australia 6102
Country 42864 0
Australia
Phone 42864 0
(+618) 9266 3442
Fax 42864 0
Email 42864 0
C.Rees@curtin.edu.au

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

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEfficacy of metacognitive therapy for prolonged grief disorder: Protocol for a randomised controlled trial.2015https://dx.doi.org/10.1136/bmjopen-2014-007221
EmbaseA pilot randomised controlled trial of metacognitive therapy for prolonged grief.2019https://dx.doi.org/10.1136/bmjopen-2017-021409
N.B. These documents automatically identified may not have been verified by the study sponsor.