Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000023550
Ethics application status
Approved
Date submitted
17/12/2014
Date registered
16/01/2015
Date last updated
11/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Group Therapy for Self-Injury in Young People
Scientific title
The efficacy of group mindfulness based cognitive therapy vs group support for self-injury among young people who self-injure: A randomised controlled trial
Secondary ID [1] 285869 0
Nil
Universal Trial Number (UTN)
U1111-1165-2973
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Self-Injury 293782 0
Condition category
Condition code
Mental Health 294086 294086 0 0
Other mental health disorders
Injuries and Accidents 294158 294158 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mindfulness-Based Cognitive Therapy (MBCT): We will utilise the standard MBCT treatment protocol. Each session combines key elements of cognitive therapy with training in mindfulness meditation. Participants are taught skills designed to foster present moment awareness which include practising mindfulness meditation, body scan, mindful walking and stretching. Cognitive therapy techniques include education about the role of negative thoughts and how rumination, avoidance, suppression, and struggling with unhelpful cognitions and emotions can perpetuate distress rather than resolve it. Participants learn to identify patterns of emotional response and negative thinking that act as warning signals for NSSI and help one another to develop crisis plans and actions to take in the event of future NSSI urges.

Participants in both conditions complete one weekly group therapy session of 2 hours duration, across 8 consecutive weeks. All sessions will be facilitated by 2 psychologists, one fully registered and one provisionally registered. All sessions will be audiotaped with a minimum of 10% of all sessions being checked for adherence to the treatment protocol by an experienced Clinical Psychologist.
Intervention code [1] 290846 0
Treatment: Other
Comparator / control treatment
Active Control: Supportive Group Therapy. The control comparison in this study is Supportive Therapy (ST): Supportive therapy is a widely used active control condition in psychotherapy outcome studies, as it controls for both the non-specific effects of any psychological intervention (i.e. therapeutic relationship) and the unique aspects of group therapy (i.e. social support). Additionally, from an ethical perspective, the group support condition ensures that no participants are left without an intervention. We will use a manualised protocol. In ST, the therapist provides empathy, fosters a supportive environment, and facilitates discussions among group members around NSSI and other life issues. No MBCT techniques are taught by the therapist.

All participants randomised to the control condition will receive weekly 2 -hour group sessions across 8 consecutive weeks. All sessions will be facilitated by 2 psychologists, one fully registered and one provisionally registered. All sessions will be audiotaped with a minimum of 10% of all sessions being checked for adherence to the treatment protocol by an experienced Clinical Psychologist.
Control group
Active

Outcomes
Primary outcome [1] 293874 0
Clinician-Rated Severity of Non-Suicidal Self-Injury: This single item scale assesses the severity of NSSI on a scale of 0=None; 1=Sub-threshold; 2=Mild; 3=Moderate; and 4=Severe. The measure was designed to capture clinically meaningful changes in NSSI severity, based on the proposed DSM-5 criteria. Therapists will rate each participant at the end of each therapeutic session.
Timepoint [1] 293874 0
Completed at the end of each therapy session as well as Pre-treatment, post-treatment and 3 and 6 month follow-up
Primary outcome [2] 293875 0
Self-Injury Monitoring Diary: Participants will complete the Self-Injury Monitoring Diary, developed for this study, across the course of the trial, to assess ongoing frequency and medical severity of NSSI. Each day participants will indicate whether they had an urge to self-injure, the strength of this urge, whether they did self-injure, and the severity of the injury.
Timepoint [2] 293875 0
Pre-treatment, post-treatment, 3 and 6 month follow-up
Primary outcome [3] 293876 0
Beck Depression Inventory - 2nd Edition (BDI-II): The BDI-II is a 21-item measures of depressive symptoms, each rated on a four-point scale. Both a continuous measure indicating severity of symptoms, and clinically meaningful cut-off scores can be obtained. The BDI-II is the gold-standard questionnaire assessment of depression and demonstrates acceptability as a screening tool in both healthy and clinical populations.
Timepoint [3] 293876 0
Pre-treatment, post-treatment, 3 and 6 month follow-up
Secondary outcome [1] 312052 0
Cognitive and Affective Mindfulness Scale - Revised (CAMS-R): The CAMS-R is a brief (12 item) self-report measure designed to assess the capacity an individual has to be mindful. The measure demonstrates internal consistence and convergent validity with similar measures when administered to university students
Timepoint [1] 312052 0
Pre-treatment, post-treatment, 3 and 6 month follow-up
Secondary outcome [2] 312053 0
Ruminative Thought Style Questionnaire (RTSQ): The RTSQ is a 20-item measure describing positive, negative and neutral facets of global rumination (e.g., “I can’t stop thinking about some things” or “I have never been able to distract myself from unwanted thoughts”). Respondents rate each statement on a 7-point Likert scale (1 = not at all descriptive of me, 7 = describes me very well). The RTSQ has demonstrated good convergent validity with the Response Style Questionnaire, the Global Rumination Scale and the Beck Depression Inventory, adequate test-retest reliability and high internal consistency
Timepoint [2] 312053 0
Pre-treatment, post-treatment, 3 and 6 month follow-up
Secondary outcome [3] 312055 0
Distress Tolerance Scale: This 14 item self-report measure assesses an individual’s ability to withstand feeling distressed. The scale assesses an individual’s ability to tolerate emotions, their appraisal of emotional situations, how absorbed they are by negative emotion and emotion regulation using 5-point Likert scales.
Timepoint [3] 312055 0
Pre-treatment, post-treatment, 3 and 6 month follow-up
Secondary outcome [4] 312056 0
Perceived Stress Scale: The Perceived Stress Scale is a 10-item assessment designed to provide a global assessment of perceived stress. Items assess how unpredictable, controllable and overloaded individuals find their lives, without reference to specific events. The scale evidences discriminant validity with depression, and internal consistency.
Timepoint [4] 312056 0
Pre-treatment, post-treatment, 3 and 6 month follow-up
Secondary outcome [5] 312057 0
Cortisol Measurement: Both cortisol awaking response (CAR) and daily slope (DS) will be assessed to obtain total daily cortisol output. Cortisol is a biomarker of stress and anxiety, and varies in response to stress among people who self-injure.
Timepoint [5] 312057 0
We will collect saliva on two consecutive days at each data collection point (pre-treatment, mid-treatment (4th week of intervention), post-treatment, 3 and 6 month follow-up). On each of these days, participants will collect saliva upon waking, 30 and 45 minutes after waking (CAR) and again at 4, 9, and 13 hours after waking (DS)
Secondary outcome [6] 312058 0
Attentional Bias: The differential allocation of attention to emotional stimuli will be assessed in simple reaction time tasks that are presented using a computer. One of these tasks is the so called ‘dot probe’, which assesses the effect of emotional cues on the detection or identification of a probe stimulus.
Timepoint [6] 312058 0
Pre-treatment, mid-treatment (4th week of intervention), post-treatment and 3 and 6 month follow-up.

Eligibility
Key inclusion criteria
Inclusion criteria include: 1) Aged 18-25 years, 2) meet proposed DSM-5 criteria for NSSI.
Minimum age
18 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they: 1) are currently receiving psychological treatment, 2) have attempted suicide in the previous 12 months, 3) exhibit acute psychosis, 4) have a diagnosis of borderline personality disorder (BPD), or 5) have prior experience of MBCT.

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)
A trained psychologist will conduct telephone interviews to assess eligibility with the single-item Clinician-Rated Severity of Non-Suicidal Self-Injury. The MINI Screen will be used to screen for current psychosis and previous suicide attempt exclusion criteria. If a participant passes the phone screen they will be invited to attend a one-on-one session with the research assistant. The participant will be provided with the participant information sheet and consent form at this face-to-face session. The researcher will answer any questions about the study at this point. The research assistant, who will also be a trained provisional psychologist, will conduct an intake assessment to establish diagnosis of mental illness, including acute psychosis and borderline personality disorder (BPD) using the full MINI International Neuropsychiatric Interview (MINI; Version 6.0) and the BPD diagnostic section of the SCID-II. The full MINI diagnostic interview takes approximately 30 mins to administer. If the participant is still eligible for the study, the research assistant will then administer the baseline self-report and cognitive tests and instruct the participant in saliva collection to assess baseline cortisol. Ineligible participants (e.g. due to diagnosis of BPD) will be appropriately referred. However, the likelihood of this will be minimised as a result of the pre-screening for BPD and psychosis. Allocation Concealment Procedure: allocation to condition will be achieved by the use of sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We will implement a computerised block randomisation procedure to ensure equal distribution of participants across conditions. As far as practically possible participants will be blind to group allocation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/04/2015
Actual
2/03/2015
Date of last participant enrolment
Anticipated
Actual
1/05/2016
Date of last data collection
Anticipated
Actual
1/05/2016
Sample size
Target
96
Accrual to date
Final
1
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 290448 0
Charities/Societies/Foundations
Name [1] 290448 0
Australian Rotary Health
Country [1] 290448 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
GPO Box U1987
Bentley, WA, 6847
Country
Australia
Secondary sponsor category [1] 289154 0
None
Name [1] 289154 0
Address [1] 289154 0
Country [1] 289154 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292122 0
Curtin Human Research Ethics Committee
Ethics committee address [1] 292122 0
Ethics committee country [1] 292122 0
Australia
Date submitted for ethics approval [1] 292122 0
Approval date [1] 292122 0
15/12/2014
Ethics approval number [1] 292122 0
4884

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

Contacts
Principal investigator
Name 53622 0
A/Prof Clare Rees
Address 53622 0
School of Psychology and Speech Pathology
Curtin University
GPO Box U1987
Bentley WA 6847
Country 53622 0
Australia
Phone 53622 0
+61 8 9266 3442
Fax 53622 0
Email 53622 0
[email protected]
Contact person for public queries
Name 53623 0
Clare Rees
Address 53623 0
School of Psychology and Speech Pathology
Curtin University
GPO Box U1987
Bentley WA 6847
Country 53623 0
Australia
Phone 53623 0
+61 8 9266 7279
Fax 53623 0
Email 53623 0
[email protected]
Contact person for scientific queries
Name 53624 0
Clare Rees
Address 53624 0
School of Psychology and Speech Pathology
Curtin University
GPO Box U1987
Bentley WA 6847
Country 53624 0
Australia
Phone 53624 0
+61 8 9266 7279
Fax 53624 0
Email 53624 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
EmbaseGroup mindfulness based cognitive therapy vs group support for self-injury among young people: Study protocol for a randomised controlled trial.2015https://dx.doi.org/10.1186/s12888-015-0527-5
N.B. These documents automatically identified may not have been verified by the study sponsor.