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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
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring the feasibility and acceptability of recovery focused group therapy for adults with bipolar disorder and difficulties with anxiety and alcohol or other drug use
Scientific title
Exploring the feasibility and acceptability of recovery focused group therapy for adults with bipolar disorder and difficulties with anxiety and alcohol or other drug use
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
Description:
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
We expect the intervention will comprise up to ten sessions of face-to-face group therapy, of between 1.5 to 2 hours (plus a 15-30 minute mid-session break) delivered across 5-8 weeks. The administration schedule will be finalised in collaboration with consumers via upcoming focus group discussion. 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, currently undertaking postgraduate 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
Description
Participants assigned to treatment as usual (TAU) will receive no additional services, but no services that are normally available will be withheld. TAU participants will be advised to continue their current treatment. Based on Clinical Guidelines for BPSD (NICE, 2015), anxiety (NICE, 2011b) alcohol (NICE, 2011a), substance use (NICE, 2007) and comorbidity (Mills, Deady, Proudfoot, Sannibale, Teesson, Mattick et al., 2010) it is expected that TAU will include one or more of the following:
* Medication management by a psychiatrist and/ or general practitioner (mood stabiliser, antipsychotic and/ or antidepressant; anxiolytic and/ or anticraving)
* Psychosocial therapy by a mental health clinician (e.g. cognitive behavioural therapy, interpersonal and social rhythm therapy, family therapy and/ or motivational interviewing)
* Mutual aid groups (e.g. Alcoholics Anonymous, SMART Recovery, Grow)
* Supported employment programmes and/ or other educational/ occupational support programmes (e.g. pre-vocational training)

TAU will be managed by the participants existing care team. Accordingly, it is not possible to specify the nature, duration and frequency of contact a priori. A key strength of the current trial is that we will collect detailed information at each follow-up occasion regarding treatment received in order to accurately describe TAU for control and intervention participants.

Excluded medications and treatments:

Participants will not be excluded on the basis of concurrent treatment (pharmacological or non-pharmacological). Information regarding any concurrent treatment will be collected at baseline each follow-up occasion.
Control group
Active

Outcomes
Primary outcome [1] 298787 0
Feasibility of delivering and evaluating a recovery focused group therapy intervention for adults with bipolar disorder, anxiety and problematic alcohol/ substance use. Feasibility will be indexed by:
* Accrual (number of referrals, source of referrals, number contacted, number meeting inclusion criteria, number consented into the study, number that agree to be randomised). Where available, reason(s) for ineligibility and withdrawal will be documented.
* Retention (attended vs. rescheduled with reason vs. failed to attend for baseline, follow-up and group therapy sessions). Where available, reason(s) for non-attendance and withdrawal will be documented.
* Number and type of adverse events (if any)
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 weekly for group therapy participants and at all assessment occasions for participants in both arms of the trial).
Primary outcome [2] 298831 0
Acceptability of delivering and evaluating a recovery focused group therapy intervention for adults with bipolar disorder, anxiety and problematic alcohol/ substance use. Acceptability will be indexed by
* Quantitative feasibility data (e.g. number of participants willing to be randomised; 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, mid-treatment, 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, mid-treatment, 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, mid-treatment, 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, mid-treatment, 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, mid-treatment, 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, mid-treatment, 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 (Intervention Group Only)

Eligibility
Key inclusion criteria
* Aged 18-65
* Meeting DSM-V criteria for BPSD (BP I, BPII, Cyclothymia, Other [Un]Specified)
* HADS-A score of > 8
* Hazardous alcohol consumption (as defined by NHMRC 2009) and/ or at least weekly substance use in the preceding one month. ‘’Substance use” will be defined as tobacco, illicit substances and non/outside of prescription use of sedatives and opioids.
* 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
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Once the baseline assessment is complete, consecutively eligible participants will be assigned a unique alphanumeric code and randomly assigned to one of two conditions:
Intervention + treatment as usual or
treatment as usual

Randomisation will be conducted off-site by an independent researcher, with stratification on number of previous mood episodes (<6 vs. >6).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be conducted off-site by an independent researcher, using a web-based randomisation engine (permuted block randomisation), with stratification on number of previous mood episodes (<6 vs. >6)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
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
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Kolling Building, Level 13
Royal North Shore Hospital
St Leonards
NSW 2065
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
Research Services
Research Integrity
Unit NIER, Block C
The University of Newcastle
Callaghan NSW 2308
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
Improving support for people with bipolar disorder is an important priority. Worldwide, bipolar disorder causes more pain and suffering than well-known conditions like heart disease and Alzheimer's. Even with the right medication, people often have symptoms that continue to affect their everyday lives. Problems with anxiety, alcohol and other drug use are also common. Research is needed on an approach to these problems that is useful and easy to access.
This study will develop and test a treatment that aims to combine help for bipolar disorder with help for anxiety, alcohol and other drugs. An important focus of the project is combining what is currently known about what works with feedback from experts, including consumers. The treatment will explore how people notice and react to thoughts, feelings and urges. It will help them work on unhelpful behaviours such as automatically avoiding things that upset them, and helpful actions like doing things that matter to them. We will use up to ten sessions of group therapy. This will make it easier to access in the ‘real world’, as groups not only deliver treatment to more people in the same period of time, they are funded by the Australian government, so can be accessed free of charge.
This initial study will involve 48 people with bipolar disorder who also experience anxiety and use alcohol or other drugs. People will be randomly assigned (i.e. by chance) to the new group treatment plus their usual treatment, or a control group who will get only their usual treatment. We will measure key signs (quality of life, mood, anxiety and alcohol/ drug use) several times before, during and after treatment (baseline, mid-treatment, post-treatment and 3 months post-treatment). We will also ask people to give feedback on their experience of participating in the study and the treatment they received. This will help to improve the treatment and inform a larger trial of its use in practice.
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
Alison.Beck@newcastle.edu.au
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
Alison.Beck@newcastle.edu.au
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
Alison.Beck@newcastle.edu.au

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