Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001114932
Ethics application status
Approved
Date submitted
12/10/2011
Date registered
25/10/2011
Date last updated
25/10/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
An examination of the relationship between self-compassion, emotion regulation, happiness and stress in practising psychotherapists, and an a randomized controlled trial of a web-based self-compassion training program for postgraduate psychology trainees
Scientific title
In adult postgraduate psychology students with low self-compassion, is an online self-compassion training program more effective than waitlist control in increasing self-compassion, improving psychological wellbeing, and reducing psychological distress?
Secondary ID [1] 273205 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Self-Compassion 278961 0
Depression Symptoms 278962 0
Anxiety Symptoms 278963 0
Stress Symptoms 278964 0
Happiness 278965 0
Emotion Regulation 278966 0
Self-Criticism 278967 0
Self-Reassurance 278968 0
Condition category
Condition code
Mental Health 279141 279141 0 0
Other mental health disorders
Mental Health 279142 279142 0 0
Depression
Mental Health 279143 279143 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study One will involve conducting a cross-sectional, correlational study of self-compassion amongst practising psychotherapists (including trainees), and using Structural Equation Modelling to explore the relationship between self-compassion and stress, as well as the potential mediating role of happiness and emotion regulation in this relationship. Measures for Study One will be administered online, and the study will be open to participants at least until the requisite sample size is reached (>155). Upon completion of the online measures for Study One, eligible participants will be given the opportunity to register for Study Two.
In Study Two, a randomized controlled trial will be conducted to investigate the utility of a self-guided, self-compassion-based intervention delivered via the Internet for increasing self-compassion, and promoting psychological well-being and resilience to stress amongst postgraduate trainee psychology students currently engaged in clinical work. In Study Two, if participants are randomly allocated to the intervention group, treatment will be based on Germer and Neff's (2011) Mindful Self-Compassion program, adapted for online administration and tailored for postgraduate students. This program is a combination of mindfulness- and self-compassion-based meditations, written and behavioural exercises, psychoeducation, self-monitoring, and feedback aimed at increasing self-compassion, increasing psychological wellbeing, and reducing psychological distress. The program will be provided through the website "Self-Compassion Online". A time period of 8 weeks will be allocated to all participants to complete the program (a total of 8 modules). It is anticipated that each module will take approximately 2 hours to complete.
Intervention code [1] 269538 0
Prevention
Intervention code [2] 269539 0
Lifestyle
Intervention code [3] 269540 0
Treatment: Other
Comparator / control treatment
If participants are randomly allocated to the control group, they will be placed on a no-intervention waitlist for 4 months. At the end of this period, they will receive access to the Self-Compassion Online in the same format as the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 279786 0
Self-Compassion Scale (SCS; Neff, 2003a). The SCS is a 26-item self-report measure comprising six subscales (self-kindness, self-judgment, common humanity, isolation, mindfulness, and over-identification) designed to assess the different facets of self-compassion proposed by Neff (2003a, 2003b). It employs a five-point Likert-type response format, ranging from 1 (almost never) to 5 (almost always).
Timepoint [1] 279786 0
Pre-test, post-test, 2-month follow-up
Primary outcome [2] 279787 0
21-Item Depression Anxiety and Stress Scales (Lovibond & Lovibond, 1995b). The stress subscale of the DASS-21 will also be used to measure stress. The DASS-21 is a 21-item self-report measure with three subscales that measure depression, anxiety and stress. It employs a four-point Likert-type response format to assess how often respondents experienced symptoms of depression, anxiety, and stress over the past week, with possible responses ranging from 0 (did not apply to me at all) to 3 (applied to me very much, or most the time). The Depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest/involvement, anhedonia, and inertia. The Anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. The Stress scale assesses levels of chronic non-specific arousal, such as difficulty relaxing, nervous arousal, and being easily upset/agitated, irritable/over-reactive and impatient.
Timepoint [2] 279787 0
Pre-test, post-test, 2-month follow-up
Primary outcome [3] 279788 0
Authentic Happiness Inventory (AHI; Peterson & Park, 2008). The AHI will be used to measure happiness. The AHI is a 24-item updated version of the Steen Happiness Index (SHI) developed by Seligman et al. (2005). Similar to the SHI, the AHI is designed to measure Seligman et al.'s (2005) conceptualization of happiness, which divides the construct into three dimensions: pleasure, meaning, and engagement. Each item consists of five statements that range from negative (I feel like a failure) to extremely positive (I feel I am extraordinarily successful). Respondents are asked to indicate the statement that best described them during the previous week. Preliminary data support the validity of the authentic happiness construct (Kaczmarek, Stanko-Kaczmarek, & Dombrowski, 2010), and the reliability of this scale, with Cronbach's alphas > .92 for each subscale and the total scale score reported in the literature (e.g., Schiffrin & Nelson, 2010; Silberman, 2007).
Timepoint [3] 279788 0
Pre-test, post-test, 2-month follow-up
Secondary outcome [1] 294427 0
Difficulties with Emotion Regulation Scale (DERS; Gratz & Roemer, 2004). The DERS will be used to measure emotion regulation. The DERS is a 36-item self-report questionnaire designed to measure problems with emotion regulation according to Gratz and Roemer's conceptualization of adaptive emotion regulation as involving four key capacities: (1) emotional awareness and understanding; (2) emotional acceptance; (3) the capacity to control impulsive behaviours when experiencing unpleasant emotions and to behave in accordance with desired goals; and (4) the ability to use appropriate emotion regulation strategies. The DERS uses a five-point Likert-type response format (1 = almost never to 5 = almost always) to measure difficulties with emotion regulation along six dimensions: (1) non-acceptance of emotions; (2) difficulties engaging in goal-directed behaviour; (3) impulse control difficulties; (4) lack of emotional awareness; (5) limited access to emotion regulation strategies; and (6) lack of emotional clarity. The DERS has exhibited good validity (Orgeta, 2009), test-retest reliability, overall internal consistency ( .93) and adequate subscale reliability, with Cronbach's alphas > .80 for each subscale (Gratz & Roemer, 2004).
Timepoint [1] 294427 0
Pre-test, post-test, 2-month follow-up
Secondary outcome [2] 294428 0
Perceived Stress Scale (PSS; Cohen, Kamarck, & Mermelstein, 1983). The PSS will be used to measure stress. The PSS is a 10-item self-report measure of cognitive appraisals of stress. Respondents are asked to rate the frequency of stressful events in the past month on a 5-point Likert-type response scale, ranging from 0 (never) to 4 (very often). The PSS has adequate construct and discriminant validity, and good reliability, with Cronbach's alpha of .85 reported in the literature (Cohen, et al., 1983; Cohen & Williamson, 1988; Roberti, Harrington, & Storch, 2006).
Timepoint [2] 294428 0
Pre-test, weekly during intervention period, post-test, 2-month follow-up
Secondary outcome [3] 294429 0
The Forms of Self-Criticising/Attacking and Self-Reassuring Scale (FSCRS; Gilbert, Clark, Hempel, Miles, & Irons, 2004). The FSCRS is a 22-item scale that measures individual's tendencies to be self-critical or self-reassuring when things go wrong. The scale measures two forms of self-critical cognitions: self-inadequacy and self-hatred, and one form of self-reassurance. Responses are given on a 5-point Likert scale (ranging from 0 = not at all like me, to 4 = extremely like me). Cronbach's alphas were 0.90 for the inadequate-self scale and 0.86 for the hated-self scale and reassured-self scale respectively. In the proposed study, the wording of the FSCRS will be changed to reflect how much the respondents experienced the various cognitions in the past week.
Timepoint [3] 294429 0
Pre-test, weekly during intervention period, post-test, 2-month follow-up

Eligibility
Key inclusion criteria
To be eligible for the study, participants must be postgraduate psychology students currently enrolled in a psychology Master’s, Doctorate, or PhD course at an Australian university, and currently undergoing clinical training, have access to the internet, and have a low self-compassion score on the SCS (i.e., a score of 65 or below; Neff, 2009b).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
NA

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
STUDY ONE: Study One is a cross-sectional, correlational study to test a structural equation model of self-compassion, emotion regulation, happiness, and stress amongst currently practising psychotherapists, including postgraduate students who are currently engaged in clinical training. Participants will be recruited via word-of-mouth, snowball recruitment via email, and advertisement on online psychology groups and websites. All measures will be administered online. Following completion of the online survey, eligible participants will be given the opportunity to register for Study Two.
STUDY TWO: During registration, participants will be asked to read the Participant Information and Consent Form, and asked to indicate whether they consent to participate in the study. Participants will then be administered a demographic screen and the SCS screen, using an online Qualtrics survey, to see if they are eligible for the study. Qualtrics skip logic will be used to direct ineligible participants to the end-of-survey page. Once eligible participants have completed screening measures, they will be asked to complete the remainder of the pre-test measures and to nominate a password. Participants will then be contacted via email/SMS with an identification number and their password. Identification numbers will remain the same throughout the duration of the program, and will be requested for program access, and at each data collection point. The nominated password will be used to access the introductory section of the website (i.e. program overview, structure, instructions for baseline assessment, opt-out information), and will remain active for the duration of the baseline period. At the close of the registration period, an online randomization tool will be used to randomly assign participants to either the waitlist control group, or the intervention group. Participants will be contacted via email/SMS to let them know which group they are in.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Saghei's (2004) Random Allocation computer software will be used to generate random number lists, which will be used to randomly assign participants to either the intervention or waitlist control group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/02/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 270030 0
University
Name [1] 270030 0
Curtin University of Technology
Country [1] 270030 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Clare Rees
Address
School of Psychology,
Curtin University of Technology
Kent Street, Bentley
Western Australia, 6102
Country
Australia
Secondary sponsor category [1] 269004 0
Individual
Name [1] 269004 0
Amy Finlay-Jones
Address [1] 269004 0
School of Psychology, Curtin University of Technology Kent Street, Bentley Western Australia, 6102
Country [1] 269004 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271986 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 271986 0
Ethics committee country [1] 271986 0
Australia
Date submitted for ethics approval [1] 271986 0
30/09/2011
Approval date [1] 271986 0
05/10/2011
Ethics approval number [1] 271986 0
Protocol Approval HR 134/2011

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

Contacts
Principal investigator
Name 33266 0
Address 33266 0
Country 33266 0
Phone 33266 0
Fax 33266 0
Email 33266 0
Contact person for public queries
Name 16513 0
Amy Finlay-Jones
Address 16513 0
School of Psychology and Speech Pathology Curtin University Kent Street, Bentley Western Australia, 6102
Country 16513 0
Australia
Phone 16513 0
+61 433 503 391
Fax 16513 0
Email 16513 0
[email protected]
Contact person for scientific queries
Name 7441 0
Associate Professor Clare Rees
Address 7441 0
School of Psychology and Speech Pathology Curtin University Kent Street, Bentley Western Australia, 6102
Country 7441 0
Australia
Phone 7441 0
+61 8 9266 3442
Fax 7441 0
+61 8 9266 2464
Email 7441 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.