Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000887471
Ethics application status
Approved
Date submitted
30/06/2016
Date registered
6/07/2016
Date last updated
19/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Recovery focused group therapy: Exploring a new treatment for adults with experience of bipolar disorder
Scientific title
Exploring the feasibility and acceptability of a recovery focused group therapy intervention for adults with a bipolar spectrum disorder
Secondary ID [1] 289562 0
None
Universal Trial Number (UTN)
U1111-1184-8003
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bipolar disorder 299290 0
Anxiety 299291 0
Alcohol and other drug misuse 299292 0
Condition category
Condition code
Mental Health 299285 299285 0 0
Other mental health disorders
Mental Health 299362 299362 0 0
Anxiety
Mental Health 299363 299363 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This recovery focused group therapy will be delivered as an adjunct to existing treatment (pharmacological and/ or psychological). The intervention is informed by Acceptance Based Behavioral Therapy (AABT), motivational interviewing (MI) and consumer feedback. ABBT integrates CBT with principles and strategies from Acceptance and Commitment Therapy (ACT; Hayes, Strosahl & Wilson, 2012), dialectical behavior therapy (DBT; Linehan, 1993) and mindfulness-based cognitive therapy (MBCT; Segal, Williams & Teasdale, 2002) to address processes implicated in Generalised Anxiety Disorder (GAD; Roemer & Orsillo, 2009). According to this approach, GAD is maintained by an interplay between a) problematic ways of relating to internal experiences (e.g. restricted/ biased attention; critical, negative and fearful stance); b) rigid strategies aimed at experiential avoidance (i.e. efforts to alter the form, frequency and/ or intensity of internal events; Hayes, Wilson, Gifford, Follette & Strosahl, 1996) and c) subsequent ‘behavioral constriction’ (narrowing or avoidance of meaningful/ valued action; Roemer & Orsillo, 2009). This model of ABBT is particularly relevant to the current trial, since as with anxiety, Bipolar Disorder and substance use are also characterized by problematic reactions to internal events (Jones & Day, 2008; Jones, Mansell & Waaller, 2006; Johnson et al. 2008), experiential avoidance and behavioural constriction (Aldao et al., 2010; Spinhoven et al., 2014).
The current intervention is designed to promote awareness of (i) how participants respond to experiences related to mood, anxiety and substance use, with a particular emphasis on the role of urges (to avoid, approach and/ or protect) and (ii) the relationship between these responses and valued living. The overarching focus will be on using this awareness to promote increased engagement in meaningful action. Sessions will consist of guided discovery, information provision and exercises (e.g. self-monitoring, mindfulness, awareness of thoughts, feelings and urges). Written material will be used to consolidate key concepts and allow participants to document ‘take home points’ of particular relevance to their own experience. The structure and content of written material will be finalised in collaboration with consumers.

Dosage and administration
The intervention will comprise eight sessions of face-to-face group therapy, of between 1.5 to 2 hours (plus a 15-30 minute mid-session break) delivered across 8 weeks. All sessions will be led by the same Clinical Psychologist (>10 years experience in research and mental health settings) and co-facilitated by the same Registered Psychologist (>5 years experience, masters level training). Sessions will be held in a community based private psychology clinic located on the Central Coast, NSW.

Treatment Integrity

Adherence to treatment protocol will be assessed via clinician ratings and separate independent objective rating of audio recorded therapy sessions. At the end of each session, the clinician will complete a rating scale specifically designed for the current study. Audio recordings will be rated using a corresponding fidelity scale specifically designed for the current study (i.e. to assess adherence to and competence in approaches to promote awareness, explore experiential avoidance, facilitate engagement in meaningful action; together with evidence based skills/ strategies for BPSD, anxiety and/ or substance use). This scale will be informed by published recommendations (e.g. Plumb & Roger, 2010; McHugh et al., 2009) and existing fidelity measures applied to ‘third wave’ interventions (e.g. Schimmell-Bristow, Bricker & Comstock, 2012). As we are unsure of how this scale will perform, we may also utilise at least one established instrument for assessing fidelity to CBT (e.g. Cognitive Therapy Scale – revised version).

All sessions will be rated by an independent assessor masked to study protocol. To maximise masking, the independent researcher will be located off-site. A 20% sample will be re-rated by a second, independent masked-rater for inter-rater reliability.
Intervention code [1] 295168 0
Treatment: Other
Intervention code [2] 295210 0
Behaviour
Intervention code [3] 295211 0
Lifestyle
Comparator / control treatment
All consenting participants will be invited to participate in the recovery focused group therapy intervention (in addition to any usual treatment).
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298787 0
Feasibility of developing and delivering an eight session recovery focused group therapy intervention for adults with BPSD. Feasibility will be indexed by enrolment (including the number of participants referred, the proportion who were eligible and the number consented); Frequency, duration and source of referrals (self vs. various service providers across each month of the trial); Number of group therapy sessions attended (and the reasons for any non-attendance); Retention to the study (including screening, baseline, intervention and follow-up) and reasons for ineligibility/ withdrawal); Number and type of adverse events (if any); Detailed participant feedback to explore their experience of and satisfaction with the intervention
Timepoint [1] 298787 0
Assessment and data collection will be ongoing throughout the trial (across baseline, intervention and follow-up periods) using a spreadsheet developed for the trial. Adverse events will be assessed at each point of contact with study participants (including during weekly group therapy sessions and at all assessment occasions ).
Primary outcome [2] 298831 0
Acceptability of delivering and evaluating an eight session recovery focused group therapy intervention for adults with BPSD. Acceptability will be indexed by * Quantitative feasibility data (e.g. number of participants willing to consent; number of sessions attended; number of drop-outs) * Semi-structured qualitative interviews with a subsample of study participants.
Timepoint [2] 298831 0
Qualitative data will be collected via semi-structured interviews conducted within one month post-treatment.
As per primary outcome 1, quantitative feasibility data collection will be ongoing throughout the trial (across baseline, intervention and follow-up periods) using a spreadsheet developed for the trial.
Secondary outcome [1] 325195 0
Measures of Clinical Outcome will be recorded at baseline and follow-ups to provide preliminary data on the effectiveness of the intervention.

Quality of life as indexed by The Brief Quality of Life in Bipolar Disorder Questionnaire. (QoL.BD; Michalak et al., 2010)
Timepoint [1] 325195 0
Baseline, post-treatment and 3 months post-treatment
Secondary outcome [2] 325196 0
Self-reported recovery as indexed by The Bipolar Recovery Questionnaire (BRQ; Jones et al., 2013)
Timepoint [2] 325196 0
Baseline, post-treatment and 3 months post-treatment
Secondary outcome [3] 325197 0
Relapse, as indexed by (i) time to first episode, (ii) number of weeks out of episode and (iii) number of weeks without impairment will be assessed by The Longitudinal Interval Follow-Up Evaluation (LIFE; Keller et al., 1987). The SCID-LIFE includes items from the SCID, the Hamilton Depression Rating Scale (HDRS; Hamilton, 1960) and the BecheRafaelsen Mania Rating Scale (MAS; Bech, Rafaelsen, Kramp, & Bolwig, 1978).
Timepoint [3] 325197 0
Baseline, post-treatment and 3 months post-treatment
Secondary outcome [4] 325198 0
Self-reported symptoms of depression as indexed by the depression subscale of the short-form version of the Depression, Anxiety and Stress Scales (DASS-21; Lovibond & Lovibond, 1995)
Timepoint [4] 325198 0
Baseline, post-treatment and 3 months post-treatment
Secondary outcome [5] 325199 0
Self-reported symptoms of anxiety as indexed by the anxiety subscale of the short-form version of the Depression, Anxiety and Stress Scales (DASS-21; Lovibond & Lovibond, 1995)
Timepoint [5] 325199 0
Baseline, post-treatment and 3 months post-treatment
Secondary outcome [6] 325200 0
Self-reported symptoms of stress as indexed by the stress subscale of the short-form version of the Depression, Anxiety and Stress Scales (DASS-21; Lovibond & Lovibond, 1995)
Timepoint [6] 325200 0
Baseline, post-treatment and 3 months post-treatment
Secondary outcome [7] 325201 0
Level of risk associated with alcohol use as indexed by the alcohol subscale of The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST 3.1; World Health Organisation, 2010)
Timepoint [7] 325201 0
Baseline, post-treatment and 3 months post-treatment
Secondary outcome [8] 325202 0
Level of risk associated with tobacco use as indexed by the tobacco subscale of The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST 3.1; World Health Organisation, 2010)
Timepoint [8] 325202 0
Baseline, post-treatment and 3 months post-treatment
Secondary outcome [9] 325203 0
Level of risk associated with cannabis use as indexed by the cannabis subscale of The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST 3.1; World Health Organisation, 2010)
Timepoint [9] 325203 0
Baseline, post-treatment and 3 months post-treatment
Secondary outcome [10] 325204 0
Level of risk associated with cocaine use as indexed by the cocaine subscale of The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST 3.1; World Health Organisation, 2010)
Timepoint [10] 325204 0
Baseline, post-treatment and 3 months post-treatment
Secondary outcome [11] 325348 0
Level of risk associated with amphetamine-type stimulant use as indexed by the amphetamine-type stimulant subscale of The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST 3.1; World Health Organisation, 2010)
Timepoint [11] 325348 0
Baseline, post-treatment and 3 months post-treatment
Secondary outcome [12] 325349 0
Level of risk associated with inhalant use as indexed by the inhalant subscale of The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST 3.1; World Health Organisation, 2010)
Timepoint [12] 325349 0
Baseline, post-treatment and 3 months post-treatment
Secondary outcome [13] 325350 0
Level of risk associated with sedative use as indexed by the sedatives or sleeping pills subscale of The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST 3.1; World Health Organisation, 2010)
Timepoint [13] 325350 0
Baseline, post-treatment and 3 months post-treatment
Secondary outcome [14] 325351 0
Level of risk associated with hallucinogen use as indexed by the hallucinogens subscale of The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST 3.1; World Health Organisation, 2010)
Timepoint [14] 325351 0
Baseline, post-treatment and 3 months post-treatment
Secondary outcome [15] 325352 0
Level of risk associated with opioid use as indexed by the opioid subscale of The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST 3.1; World Health Organisation, 2010)
Timepoint [15] 325352 0
Baseline, post-treatment and 3 months post-treatment
Secondary outcome [16] 325353 0
Level of risk associated with other substance use as indexed by the other subscale of The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST 3.1; World Health Organisation, 2010)
Timepoint [16] 325353 0
Baseline, post-treatment and 3 months post-treatment
Secondary outcome [17] 325354 0
The following process measures will be used to explore the relationship between psychological/ therapeutic processes and potential change in clinical outcome.
Mindfulness as indexed by the 24-item short form (Bohlmeijer et al. 2011) of The Five Facet Mindfulness Questionnaire (FFMQ; Baer et al., 2006).
Timepoint [17] 325354 0
Baseline, post-treatment and 3 months post-treatment
Secondary outcome [18] 325355 0
Psychological flexibility as indexed by the acceptance and action questionnaire (AAQ-2; Bond et al., 2011)
Timepoint [18] 325355 0
Baseline, post-treatment and 3 months post-treatment
Secondary outcome [19] 325356 0
Engagement in values driven behaviour as indexed by The Valuing Questionnaire (VQ; Smout et al., 2014).
Timepoint [19] 325356 0
Baseline, post-treatment and 3 months post-treatment
Secondary outcome [20] 325357 0
Medication adherence as indexed by The Medication Adherence Rating Scale (MARS; Thompson, Kulkarni & Sergejew, 2000).
Timepoint [20] 325357 0
Baseline, post-treatment and 3 months post-treatment
Secondary outcome [21] 325365 0
Group-therapy alliance as indexed by the Group Session Rating Scale (GSRS; Duncan & Miller, 2007)
Timepoint [21] 325365 0
At the completion of every group therapy session
Secondary outcome [22] 333355 0
Health service and medication use as indexed by an adapted version of The Client Service Receipt Inventory (CSRI) – ‘Generic’ UK Mental Health (Beecham & Knapp, 2001).
Timepoint [22] 333355 0
Baseline, post-treatment and 3 months post-treatment
Secondary outcome [23] 333356 0
Social and occupational functioning as indexed by The Social and Occupational Functioning Assessment Scale (SOFAS;(Goldman, Skodol et al. 1992)
Timepoint [23] 333356 0
Baseline, post-treatment and 3 months post-treatment
Secondary outcome [24] 333357 0
Health related quality of life and quality adjusted life years (QALY) as indexed by The EuroQol-five dimensions questionnaire (EQ-5D-L; Herdman, Gudex, Lloyd, Janssen, Kind, Parkin et al., 2011)
Timepoint [24] 333357 0
Baseline, post-treatment and 3 months post-treatment
Secondary outcome [25] 333358 0
Impulsivity as indexed by The Positive Urgency Measure (PUM; Cyders et al., 2007); The Urgency Subscale of the Urgency, Premeditation, Perseverance and Sensation seeking scale (Whiteside and Lynam, 2001) and The Self-control Schedule (Rosenbaum, 1980)
Timepoint [25] 333358 0
Baseline, post-treatment and 3 months post-treatment

Eligibility
Key inclusion criteria
* Aged 18-65
* Meeting DSM-V criteria for BPSD (BP I, BPII, Cyclothymia, Other [Un]Specified)
* Able to comprehend English at a level sufficient to complete self-report instruments and clinical interview (i.e. reading age of 12)
* Willing to have group therapy sessions audio recorded
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Acute mood episode (as per DSM-V criteria for mania or depression) currently or in the preceding four weeks
* Current suicidal ideation with intent
* Unable or unwilling to provide informed consent

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)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Single group
Other design features
To help inform the development of a future trial, the assessment tools listed under secondary outcomes will be used to assess a number of clinical outcomes and process measures to explore the following parameters: The feasibility of recruiting participants with bipolar disorder who also have experience of anxiety and substance related comorbidities, as indexed by the number of participants recruited who also demonstrate comorbid anxiety and substance (mis)use; The feasibility and acceptability of data collection methods (including the number, frequency, duration, content and delivery method), as indexed by the number of assessments completed; amount of missing data and detailed participant feedback; Concurrent treatment and support services accessed by study participants (including type, amount, frequency and duration) – to allow us to comment on what ‘treatment as usual’ is likely to consist of and potential similarities/ differences to the recovery focused group therapy intervention; The most appropriate primary outcome measure – informed by a combination of detailed participant feedback, feasibility data and effect size estimates; Potential mechanisms of change – to understand the processes that may underlie the impact of the intervention- including (i) mindfulness (ii) experiential avoidance (iii) meaningful action (iv) impulsivity and/ or (v) behaviours and/ or attitudes towards medication
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
In light of the primary aim of exploring feasibility and acceptability, outcome data will primarily utilise descriptive statistics (summarizing recruitment, demographics, attendance, attrition and intervention adherence). We intend to use repeated-measures analysis of covariance to analyse data on clinical outcome measures across all time points (including change, effect size and variability); this will minimise the number of statistical tests and reduce the risk of inflated type I error. This approach also provides an omnibus test, which if significant, will preserve type I error when doing post-hoc analyses of pairwise contrasts, e.g. baseline vs midpoint, baseline vs final, baseline vs post treatment values.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/07/2016
Actual
15/07/2017
Date of last participant enrolment
Anticipated
31/07/2017
Actual
2/08/2017
Date of last data collection
Anticipated
31/12/2018
Actual
23/11/2017
Sample size
Target
24
Accrual to date
Final
4
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 13491 0
2250 - Erina

Funding & Sponsors
Funding source category [1] 293947 0
Other Collaborative groups
Name [1] 293947 0
NHMRC Centre of Research Excellence in Mental Health and Substance Use (Stipend)
Country [1] 293947 0
Australia
Primary sponsor type
Individual
Name
Dr Alison Beck
Address
Postdoctoral Research Associate
University of Newcastle, NHMRC CREMS
Level 5, McCauley Building
Calvary Mater Hospital
Waratah, NSW 2298

Clinical Psychologist
R.E.A.D. Clinic
20/24 Karalta Rd,
Erina, NSW 2250
Country
Australia
Secondary sponsor category [1] 292769 0
University
Name [1] 292769 0
University of Newcastle
Address [1] 292769 0
School of Medicine & Public Health
Level 5, McAuley Centre
Calvary Mater Hospital
Edith Street
Waratah, NSW, 2298
Country [1] 292769 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295370 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 295370 0
Ethics committee country [1] 295370 0
Australia
Date submitted for ethics approval [1] 295370 0
29/02/2016
Approval date [1] 295370 0
11/04/2016
Ethics approval number [1] 295370 0
RESP/16/45; HREC/16/HAWKE/69
Ethics committee name [2] 295371 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 295371 0
Ethics committee country [2] 295371 0
Australia
Date submitted for ethics approval [2] 295371 0
07/04/2016
Approval date [2] 295371 0
24/05/2016
Ethics approval number [2] 295371 0
H-2016-0107

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

Contacts
Principal investigator
Name 66990 0
Dr Alison Beck
Address 66990 0
Postdoctoral Research Associate
School of Medicine & Public Health
University of Newcastle & NHMRC CREMS
Level 5, McCauley Building
Edith Street
Calvary Mater Hospital
Waratah, 2298
Country 66990 0
Australia
Phone 66990 0
+61 2 40335690
Fax 66990 0
Email 66990 0
[email protected]
Contact person for public queries
Name 66991 0
Alison Beck
Address 66991 0
Postdoctoral Research Associate
School of Medicine & Public Health
University of Newcastle & NHMRC CREMS
Level 5, McCauley Building
Edith St
Calvary Mater Hospital
Waratah, 2298
Country 66991 0
Australia
Phone 66991 0
+61 2 40335690
Fax 66991 0
Email 66991 0
[email protected]
Contact person for scientific queries
Name 66992 0
Alison Beck
Address 66992 0
Postdoctoral Research Associate
School of Medicine & Public Health
University of Newcastle & NHMRC CREMS
Level 5, McCauley Building
Edith Street
Calvary Mater Hospital
Waratah, 2298
Country 66992 0
Australia
Phone 66992 0
+61 2 40335690
Fax 66992 0
Email 66992 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

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseExploring the feasibility and acceptability of a recovery-focused group therapy intervention for adults with bipolar disorder: Trial protocol.2018https://dx.doi.org/10.1136/bmjopen-2017-019203
N.B. These documents automatically identified may not have been verified by the study sponsor.