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Trial History Detail on 2015-01-02

CUHK_CCT00378

2013-08-15

Prospective

CRE-2013.160-T

Health and Medical Research Fund

Winnie W. S. Mak

N/A

Winnie W. S. Mak

Department of Psychology, The Chinese University of Hong Kong, 3rd Floor, Sino Building, Shatin, N.T., Hong Kong

39436577

wwsmak@psy.cuhk.edu.hk

The Chinese University of Hong Kong

Winnie W. S. Mak

Department of Psychology, The Chinese University of Hong Kong, 3rd Floor, Sino Building, Shatin, N.T., Hong Kong

39436577

wwsmak@psy.cuhk.edu.hk

The Chinese University of Hong Kong

Cultivation of self-compassion and mindfulness through mobile applications for the promotion of mental well-being: a randomized controlled trial

Cultivation of self-compassion and mindfulness through mobile applications for the promotion of mental well-being: a randomized controlled trial

Cultivation of self-compassion and mindfulness through mobile applications

Hong Kong

Yes

2013-04-12

mental health

Other

Psychological

Mobile self-compassion programme and mobile mindfulness programme

4 weeks, with 3-month follow-up

mobile psychoeducation application

(1) age over 18, (2) read and understand Chinese, (3) own a smartphone/ tablet device, and (4) have consistent access to the mobile internet.

(1)below 18 years old and (2) being unable to read Chinese

18

n/a

Both Male and Female

Interventional

Randomized

Active

Single-blind

Parallel

2015-01-19

558

Not Yet Recruiting

The following measures will be assessed at pre-programme, post-programme, and 3-month follow-up:
(1) Mental well-being: Global mental well-being will be measured by the WHO 5-item Well-being index (WBI). Participants are asked to indicate how they have been feeling over the last two weeks on a 6-point Likert scale from 0 (at no time) to 5 (all of the time). The K6+ self-report measure will also be used. It is a simple measure of psychological distress which involves 6 questions about a person's emotional state. Each question is scored from 0 (None of the time) to 4 (All of the time).

(2)Psychological distress. Psychological distress is measured by two instruments, the 9-item depression scale of the Patient Health Questionnaire (PHQ-9) (Kroenke, Spitzer & Williams, 2001) and the 7-item Generalized Anxiety Disorder Assessment (GAD-7) (Spitzer, Kroenke, Williams & Lowe, 2006). On both instruments, participants are asked about how often they have been bothered by the problems described in each item on a 4-point Likert scale from 0 (not at all) to 3 (nearly every day). The two scales have been shown to have an internal consistency of .92 (GAD-7) and .89 (PHQ-9) by Spitzer and colleagues.

(3) Peace of Mind: To include a well-being measure that fits more with Chinese culture, the 7-item Peace of Mind Scale (PoM), developed by Lee, Lin, Huang & Fredrickson (2013), is used. Peace of mind was defined as an internal state of peacefulness and harmonious state of happiness. Such affective well-being is valued in Chinese culture. Participants rate on a 5-point Likert scale ranging from 1 (not at all) to 5 (all of the time). It was shown to have a reliability coefficient of .91.

Kroenke, K., Spitzer, R. L., & Williams, J. B. W. (2001). The PHQ-9: Validity of a Brief Depression Severity Measure. Journal of General Internal Medicine, 16, 606-613.

Lee, Y. C., Lin, Y. C., Huang, C. L., & Fredrickson, B. L. (2013). The construct and measurement of Peace of Mind. Journal of Happiness Studies, 14, 571-590.

Psychiatric Research Unit. WHO (Five) Well-Being Index (1998 version). WHO Collaborating Center for Mental Health, Frederiksborg General Hospital (Danish); 1998.

The following measures will be assessed at pre-programme, post-programme, and 3-month follow-up:
(1) Self-compassion: To evaluate the effectiveness of the mobile application to enhance ones’ self-compassion, the Self-Compassion Scale, originally developed by Neff (2003) will be used. We will use the 13-item version Self-Compassion Scale established by Mak and colleagues (2014) to assess participants’ reactions towards oneself in difficult times at pre, post and 3-month follow-up. Three factors are confirmed in this version, namely (1) Tenderness and Openness towards the Self, (2) Balanced Perspective of Human Condition, and (3) Shared Emotional Experience. The internal consistency of these factors are .82, .68 and .76 respectively based on a Hong Kong sample (Mak and colleagues, 2014). Participants rate on a 5-point Likert scale ranging from 1 (almost never) to 5 (almost always).

(2) Mindfulness: Three scales are used to evaluate the effectiveness of the mobile application to cultivate mindfulness. They are :
(i) The Five-Facet Mindfulness Questionnaire (FFMQ) (Baer, Smith, Hopkins, Krietemeyer & Toney, 2006) is used to measure participants’ trait-like general tendency to be mindful in daily life at the pre, post and 3-month follow-up. The original questionnaire contains 39 items. A Chinese version of FFMQ was validated by Hou, Wong, Lo, Mak & Ma (2013) and was found to have high internal consistency of .83 in the community sample and .80 in clinical sample. A 20-item short form was developed and was found to have a very high correlation with the full form (r = .96) (Hou and colleagues, 2013). It is on a 5-point Likert Scale ranging from 1 (never or very rarely true) to 5 (very often or always true).

(ii) Non-attachment Scale – Five items will be extracted from the 30-item original non-attachment scales (Sahdra et al., 2010) to measure participants level of non-attachment. Questions are rated on a 6-point Likert-type scale ranging from 1 “disagree strongly” to 6 “agree strongly”. These five items were shown to have the highest factor loadings from previous study.

(iii) Mindful Attention and Awareness Scale (MAAS) - Five items will be extracted from the 15-item MAAS (Brown & Richard, 2003) for measuring attention to and awareness across different domains of experience in life. Questions are rated on a 7-point scale, with 1 (almost always) to 6 (almost never). These five items were shown to have the highest factor loadings from previous study.

(3) Self-criticism. Self-criticism is one of the potential moderators in this study. It is measured by The Forms of the Self-Criticizing/Attacking and Self Reassuring Scale (FSCRS). This 22-item scale was developed by Gilbert, Clarke, Hempel, Miles & Irons (2004) to measure how people say or do to themselves when confronted with a set-back. . It is on a 5-point Likert Scale ranging from 0 (not at all like me) to 4 (extremely like me), to tap self-criticism and self-reassurance. The items made up three components, of which two are forms of self-criticalness. They include (1) inadequate self, which focuses on a sense of personal inadequacy, and (2) hated self, which measures the desire to hurt or persecute the self. The third component is reassure self, which measures how likely one reassures the self when confronting with a set-back. For the purpose of this study, only the Inadequate Self and Hated Self subscale are used, which contains a total of 14 items.

(4) Discomfort with Emotion. Discomfort with emotion is another potential moderator in this study. It is measured by the Affective Control Scale (ACS; Williams, Chambless & Ahrens, 1997), which assesses fear of losing control over one’s emotions or fear of one’s behavioral reactions to emotions. Items are rated on 7-point Likert-type scale ranging from 1 (very strongly disagree) to 7 (very strongly agree). The original scale contains a total of 42-items, with 8-item subscales for depression and anger, and 13-item for anxiety and positive affect. In the present study, we decide to extract only three items from each subscale, combining to a 12-item short form of ACS. Pilot test showed that this 12-item short form ACS demonstrated a satisfactory internal consistency of .87.

(5) Tolerance for ambiguity. The third potential moderator, tolerance for ambiguity, is measured by (1) 22-item Multiple Stimulus Types Ambiguity Tolerance (MSTAT-I) (Mclain, 1993) and (2) the 9-item Discomfort with ambiguity subscale from Need for closure scale. For MSTAT-I, participants rate on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree), while for Discomfort with ambiguity subscale from Need for closure scale, items are rated on a 6-point Likert Scale ranging from 1 (Strongly disagree) to 6 (strongly agree).

(6) Client Satisfaction Questionnaire. The 8-item Client Satisfaction Questionnaire (CSQ; Larsen, 1979) to indicate their attitude towards and satisfaction with the smartphone-based interventions on a 4-point Likert scale.


Baer, R. A., Smith, G. T., Hopkins, J., Krietemeyer, J., & Toney, L. (2006). Using self-report assessment methods to explore facets of mindfulness. Assessment, 13, 27-45.

Brown, K. W., & Ricahrd, M. R. (2003). The benefits of being present: Mindfulness and its role in psychological well-being. Journal of Personality and Social Psychology, 84, 822.

Gilbert P, Procter S. Compassionate mind training for people with high shame and self-criticism: Overview and pilot study of a group therapy approach. Clinical Psychology and Psychotherapy. 2006 Nov-Dec; 13:353-379.

Hou, J., Wong, S. Y. S., Lo, H. H. M, Mak, W. W. S. and Ma, H. S. W. (2013). Validation of a Chinese Version of the Five Facet Mindfulness Questionnaire in Hong Kong and development of a Short Form. Assessment, DOI: 10.1177/1073191113485121

Larsen, D. L., Attkisson, C. C., Hargreaves, W. A., & Nguven, T. D. (1979). Assessment of client/patient satisfaction: Development of a general scale. Evaluation and program planning, 2, 197-207.

Mclain, D. L. (1993). The Mstat-I: A new measure of an individual’s tolerance for ambiguity. Educational and Psychological Measurement, 53, 183-189.

Neff KD. The development and validation of a scale to measure self-compassion. Self and Identity. 2003 Jul-Sep; 2(3):223-250.

Sahdra, B. K., Shaver, P. R., & Brown, K. W. (2010). A scale to measure non- attachment: A Buddhist complement Western research on attachment and adaptive functioning. Journal of Personality Assessment, 92, 16-127

Williams, K. E., Chambless, D. L., & Ahrens, A. (1997). Are emotions frightening? An extension of the fear of fear construct. Behavior Research and Therapy, 35, 239-248.

No

2016-01-04

ChiCTR-TRC-13003468


Yes

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