Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000425695
Ethics application status
Approved
Date submitted
9/04/2014
Date registered
17/04/2014
Date last updated
16/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A Preliminary Evaluation of an Acceptance and Commitment Therapy Based Program for Adult Congenital Heart Disease Patients.
Scientific title
A Preliminary Evaluation of an Acceptance and Commitment Therapy Based Program for Adult Congenital Heart Disease Patients to improve psychological resilience.
Secondary ID [1] 284410 0
nil
Universal Trial Number (UTN)
U1111-1155-5159
Trial acronym
RACHD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
resilience 291605 0
depression 291606 0
anxiety 291607 0
stress 291608 0
quality of life 291609 0
Adult congenital heart disease 291611 0
Condition category
Condition code
Mental Health 291983 291983 0 0
Depression
Mental Health 291984 291984 0 0
Anxiety
Cardiovascular 292062 292062 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The READY (Resilience for Everyday) intervention was developed by Drs Pakenham and Burton at The University of Queensland (Burton et al., 2010; 2009). The program utilses an Acceptance and Commitment Therapy modality (ACT). ACT (Hayes et al., 2011) is a “third wave” cognitive behavioural therapy based on mindfulness and acceptance processes (Hayes, Luoma, Bond, Masuda & Lillis, 2006). ACT uses six interrelated core therapeutic processes: (1) acceptance - the active and aware embrace of internal experiences without changing their frequency or form, (2) cognitive defusion – observing thoughts rather than taking them literally, (3) contact with the present moment - ongoing non-judgmental and responsive awareness of present moment, (4) self-as context - awareness of one’s own flow of experiences without attachment to them, (5) values – freely chosen verbally constructed and personally meaningful life directions, (6) committed action – values-guided effective action. Further, application of these processes to the practitioner’s own psychology is critical to keeping “his or her therapeutic instrument in tune” (Luoma, Hayes & Walser, 2007). Early evidence suggests that ACT is more effective than control conditions, and that ACT constructs are correlated with better mental and physical health outcomes in a variety of populations including people with chronic medical conditions (for reviews see Hayes, & Masuda et al., 2004; Hayes et al., 2006; Powers, Zum Vorde Sive Vording & Emmelkamp, 2009; Ruiz, 2010).The READY (Resilience for Everyday) program aims to improve an individual’s resilience protective factors identified from empirical literature (i.e. positive emotions, cognitive flexibility, social support, life meaning, and active coping) (Southwick et al, 2005). The strengthening of these protective factors builds resilience towards stress and adversity and improves QoL (Burton et al., 2010).

The READY program in total is 5 sessions and includes one session per week, over a 5 week period. The first session is a 2 hour group session, and the 4 subsequent sessions are over the phone. Telephone consultations last 1 hour each.

The READY program is delivered by psychologists or provisionally registered psychologists who are currently completing postgraduate training and who receive supervision from an accredited supervisor.
Intervention code [1] 289156 0
Prevention
Intervention code [2] 289157 0
Lifestyle
Intervention code [3] 289158 0
Behaviour
Comparator / control treatment
The study will be a pre-post group (n = less than 30) intervention evaluation with three-month follow up assessment. Quantitative and qualitative data will be collected via questionnaires at pre-intervention, post-intervention and at three months follow-up.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291883 0
Resilience. The 15-item Resilience Scale (RS-15; Neill & Dias, 2001) was used to assess psychological resilience. Each positively-phrased item is scored on a 7-point likert scale (1 = disagree; to 7 = agree) and asks participants to assess their beliefs about their ability to manage stress (e.g. “I have self-discipline”). Item scores are summed, with higher scores indicating higher global resilience. The RS-15 is a refined version of the original 25 item measure by Wagnild and Young (1993), with demonstrated improved reliability (Neill, 2011). Windle et al. (2011) note the RS-15 had the widest application of reviewed measures of resilience. The measure possesses a Cronbach’s alpha of .91 (Neill & Dias, 2001).
Timepoint [1] 291883 0
Pre intervention (approximately two weeks before intervention), post intervention (approximately two weeks post), and three month follow-up.
Primary outcome [2] 291939 0
Quality of life. WHOQOL-BREF. The 26-item The World Health Organisation Quality of Life Questionnaire – Brief Form (WHOQOL-BREF; WHO, 1998) was used to assess quality of life. It provides a measure of global quality of life and four dimensions of quality of life (WHO, 1996): physical QoL (e.g. “How satisfied are you with your sleep?”; 1 = Very dissatisfied to 5 = Very satisfied); psychological QoL (e.g. “To what extent do you feel your life to be meaningful?”; 5 = Not at all to 1 = An extreme amount); social relations QoL, (“How satisfied are you with your personal relationships?”; 1 = Very dissatisfied to 5 = Very satisfied); and environmental QoL (“How healthy is your physical environment?”; 1 = Not at all to 5 = Extremely). Some items are reverse scored (“To what extent do you feel that physical pain prevents you from doing what you need to do?”; 5 = Not at all to 1 = An extreme amount). To develop scale sores, relevant items are reverse scored, domain items are summed, and the mean of this total score provides the domain score. Higher scores indicate higher quality of life. The WHOQOL BREF possesses similar psychometric properties to the full measure, demonstrating good discriminant validity, content validity, and test-retest reliability (WHO; 2004). The measure is a reliable and established measure of how disease impacts an individual’s subjective wellbeing (WHO; 1997). Cronbach’s alpha values for each of the six domain scores ranged from .71 (domain 4) to .86 (domain 5) (WHO, 1998). An interesting addition to the current study’s assessment of QoL was analysis of self-rated QoL and health satisfaction. The WHOQOL-BREF Manual (WHO, 1997) recommends individual examination of Question 1 (“How would you rate your quality of life?”) and Question 2 (“How satisfied are you with your health?”).
Timepoint [2] 291939 0
Pre intervention (approximately two weeks before intervention), post intervention (approximately two weeks post), and three month follow-up.
Primary outcome [3] 291940 0
Mood (DASS21). The Short Version of the Depression Anxiety Stress Scale (DASS-21; Lovibond & Lovibond, 1995) was used to assess mood. The DASS-21 uses 21 self report items to assess the presence of negative affective states over the past two weeks. There are three subscales: depression (e.g. “I couldn’t seem to experience any positive feelings at all”); anxiety (e.g. “I felt I was using a lot of nervous energy”); stress (e.g. “I felt that I was rather touchy”). In the present study, instructions were modified to query the presence of symptoms “over the past week”. This was done to reduce overlap with the intervention (i.e. assessing two weeks, rather than one, would have gained data on participants’ emotional states prior to the intervention being completed). Items are scored on a 4-point likert scale (0 = not at all to 3 = most of the time). Items are summed for each subscale, and then multiplied by two to give scores comparable to the full version, and higher scores indicate greater intensity of symptoms (DASS-42; Lovibond & Lovibond, 1995). The measure possesses excellent psychometric properties, with good convergent validity, and excellent internal consistency, temporal stability, and discriminant and convergent validity in both clinical and community samples (Brown et al., 1997; Lovibond & Lovibond, 1995). Alpha coefficients for the depression, anxiety, and stress subscales were .91, .84, and .90 respectively (Lovibond & Lovibond, 1995).
Timepoint [3] 291940 0
Pre intervention (approximately two weeks before intervention), post intervention (approximately two weeks post), and three month follow-up.
Secondary outcome [1] 307732 0
The Acceptance and Action Questionnaire II (AAQII; (Bond et al., 2011) assessed psychological flexibility and experiential avoidance. The AAQII asks participants to respond to ten 7-point likert-scaled items (1 = never true to 7 = always true) that examine willingness to accept uncomfortable feelings and thoughts (e.g. “I’m afraid of my feelings”). Items are summed, and higher scores indicate greater acceptance, less experiential avoidance, and higher values-based, committed action. The measure demonstrates adequate structure, reliability, and validity (Bond et al., 2011), acceptable criterion validity, factorial validity (Hayes et al., 2006), and discriminant validity (Bond et al., 2011), and satisfactory reliability with group comparisons, with good incremental and construct validity (Fledderus et al., 2012). Alpha coefficients range from .80 - .87 (Bond et al., 2011).
Timepoint [1] 307732 0
Pre intervention (approximately two weeks before intervention), post intervention (approximately two weeks post), and three month follow-up.
Secondary outcome [2] 307884 0
Health Behaviours (HBS-CHD). The Health Behaviour Scale-Congenital Heart Disease (HBS-CHD) measure includes 25 questions on 22 components of health risk behaviour, which evaluates the domains of; alcohol use, tobacco use, illicit drug use, dental hygeine, and physical activity levels. Items include, "do you consume alcohol from time to time? (by alcohol is meant: beer, wine, liquor, coolers)." The measure has been found to have good content validity, and capacity to detect clinical changes in health behaviour over time (Goossens, Luyckx, Mommen, Gewillig, Budts, Zupancic, & Moons, 2013).
Timepoint [2] 307884 0
Pre intervention (approximately two weeks before intervention), post intervention (approximately two weeks post), and three month follow-up.

Eligibility
Key inclusion criteria
Participants has an adult congenital heart defect and is being treated at the Prince Charles Hospital
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not having a congenital heart disease
Significant intellectual impairment
Under 16 years of age

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



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To date there have been no evaluation of psychological interventions with adult CHD patients (Kovacs, 2006). This is surprising given adult patients with CHD have indicated that they would like assistance with the following areas: stress management, coping, managing mood and anxiety, anger management, relationship difficulties and assistance with substance abuse (Kovacs et al., 2009). The aim of the proposed study is therefore to formally pilot an evaluation of the effectiveness of a psychological resilience training intervention called READY for adult patients with CHD.
Quantitative analyses involving analysis of variance (ANOVAs), as well as qualitative analyses, that being thematic analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2014
Actual
21/01/2015
Date of last participant enrolment
Anticipated
4/11/2015
Actual
13/06/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
17
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 2305 0
The Prince Charles Hospital - Chermside

Funding & Sponsors
Funding source category [1] 289058 0
University
Name [1] 289058 0
The University of Queensland
Country [1] 289058 0
Australia
Funding source category [2] 289059 0
Charities/Societies/Foundations
Name [2] 289059 0
HeartKids Queensland
Country [2] 289059 0
Australia
Primary sponsor type
Hospital
Name
The Prince Charles Hospital
Address
Rode Road, Chermside, QLD, 4032
Country
Australia
Secondary sponsor category [1] 287726 0
University
Name [1] 287726 0
The University of Queensland
Address [1] 287726 0
St Lucia, Brisbane, Queensland, 4072
Country [1] 287726 0
Australia
Other collaborator category [1] 278704 0
Individual
Name [1] 278704 0
Bronwyn Steele
Address [1] 278704 0
C/O) The School of Psychology, The University of Queensland, St Lucia QLD 4072.
Country [1] 278704 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290857 0
Human Research Ethics Committee - Metro North Hospital and Health Service, The Prince Charles Hospital
Ethics committee address [1] 290857 0
Ethics committee country [1] 290857 0
Australia
Date submitted for ethics approval [1] 290857 0
Approval date [1] 290857 0
31/03/2014
Ethics approval number [1] 290857 0
HREC/14/QPCH/31
Ethics committee name [2] 293857 0
The University of Queensland
Ethics committee address [2] 293857 0
Ethics committee country [2] 293857 0
Australia
Date submitted for ethics approval [2] 293857 0
Approval date [2] 293857 0
02/10/2014
Ethics approval number [2] 293857 0

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

Contacts
Principal investigator
Name 47610 0
Dr James Kirby
Address 47610 0
1 Campbell Drive, Parenting and Family Support Centre, The University of Queensland, St Lucia, QLD, 4072
Country 47610 0
Australia
Phone 47610 0
+61 7 3365 7290
Fax 47610 0
Email 47610 0
[email protected]
Contact person for public queries
Name 47611 0
James Kirby
Address 47611 0
1 Campbell Drive, Parenting and Family Support Centre, The University of Queensland, St Lucia, QLD, 4072
Country 47611 0
Australia
Phone 47611 0
+61 7 3365 7290
Fax 47611 0
Email 47611 0
[email protected]
Contact person for scientific queries
Name 47612 0
James Kirby
Address 47612 0
1 Campbell Drive, Parenting and Family Support Centre, The University of Queensland, St Lucia, QLD, 4072
Country 47612 0
Australia
Phone 47612 0
+61 7 3365 7290
Fax 47612 0
Email 47612 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
No additional documents have been identified.