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Trial Detail

CUHK_CCT00453

2015-05-20

Prospective

CRE-2014.063-T

Health and Medical Research Fund

Health and Medical Research Fund

N/A

Winnie W. S. Mak

Department of Psychology, The Chinese University of Hong Kong, Shatin, New Territories, 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, Shatin, New Territories, Hong Kong

39436577

wwsmak@psy.cuhk.edu.hk

The Chinese University of Hong Kong

Internet-based mindfulness and rumination-focused cognitive behavioural therapy as selective prevention of anxiety and depression: A randomised controlled trial

Internet-based mindfulness and rumination-focused cognitive behavioural therapy as selective prevention of anxiety and depression: A randomised controlled trial

網上心理健康計劃

Internet-based mindfulness and rumination-focused cognitive behavioural therapy as selective prevention of anxiety and depression: A randomised controlled trial

Hong Kong

Yes

2014-03-05

Mental Health

Other

Psychological

Internet-based mindfulness and internet-based rumination-focused cognitive behavioural therapy

6 weeks, with 3-month follow-up

Internet-based education control

(1) score above 66th percentile on either measure of worry (≥ 47 on PSWQ) or rumination (40 ≥ on RRS), i.e., at elevated risk because of increased propensity to rumination/worry, (2) at least 18 of age, (3) read and understand Chinese and spoken Cantonese, (4) are computer literate, (5) have consistent access to the internet

(1) having a DSM IV diagnosis of current or past major depressive episodes, generalised anxiety disorder, manic episodes, and psychotic disorders , and (2) actively suicidal

18

999

Both Male and Female

Interventional

Randomized

Active

Single-blind

Parallel

2015-09-01

459

Not Yet Recruiting

The following measures will be assessed at pre-programme, post-programme, and 3-month follow-up.
Depression and anxiety. The 9-item Patient Health Questionnaire (PHQ-9) and the 7-item Generalized Anxiety Disorder (GAD-7) scale will be used to assess depression and anxiety symptoms, respectively. PHQ-9 has been validated and used widely in both medical settings and general population (1) for screening and monitoring the severity of depression with validated cut-offs. At the cut-off of 10 (range 0-27), PHQ-9 has the sensitivity of 0.88 and specificity of 0.88 in detecting major depressive disorder (2). GAD-7 is a brief scale for anxiety symptoms, with cut-offs for probable generalised anxiety disorder. It has good reliability, criterion, construct, factorial, and procedural validity (3). At the cut-off of 10 (range 0-21), GAD-7 has the sensitivity of 0.89 and specificity of 0.82 in detecting generalised anxiety disorder19. The M.I.N.I. will also be used at post- and 3-month follow-up to establish diagnostic status.

1. Martin A, Rief W, Klaiberg A, Braehler E. Validity of the brief patient health questionnaire mood scale (PHQ-9) in the general

2. Kroenke K, Spitzer RL, Williams JB. The PHQ-9: Validity of a brief depression severity measure. Journal of General Internal Medicine. 2001:16:606-613.

3. population. General Hospital Psychiatry. 2006;28(1):71-77
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Archives of Internal Medicine. 2006;166(10):1092-1097

The following measures will be assessed at pre-programme, post-programme, and 3-month follow-up.

Mediators
Rumination and worry. The Ruminative Response Scale of the Response Styles Questionnaire (RRS;1) is a 22-item self-report assessment on the frequency of rumination about the depressed mood, with items relating to the self, symptoms, causes and consequences of the mood. It is rated from 1 (almost never) to 4 (almost always). The Penn State Worry Questionnaire (PSWQ; 2) is a 16-item scale assessing worry. It is rated from 1 (not at all typical of me) to 5 (very typical of me). They are the most commonly used scales to measure repetitive negative thinking and have been used among Chinese samples.


Mindfulness. The mostly commonly used mindfulness measure, the Five Facets Mindfulness Questionnaire (FFMQ;3), will be used to assess five domain of mindfulness including nonreactivity, observing, acting with awareness, describing, and nonjudging. It consists of 39 items rated from 1 (never or very rarely true) to 5 (very often or always true). It has been translated into Chinese and used among local samples by the PI (Mak) and the co-I (Wong).

Behavioural activation. The 25-item Behavioral Activation for Depression Scale (BADS, 4) will be used to assess the level of behavioural activation and avoidance. It consists of four subscales rated from 0 (not at all) to 6 (completely): activation, avoidance/rumination, work/school impairment, and social impairment. Findings demonstrated adequate test-retest reliability, internal consistency, and construct validity using both non-clinical and depressed populations.

Moderator
Tolerance of ambiguity. The 22-item Multiple Stimulus Types Ambiguity Tolerance (MSTAT-I, 5) will be used to assess individual’s tolerance of ambiguity. It has satisfactory internal reliability (alpha = 0.86) and convergent validity. It is rated on a 7-point Likert scale, ranging from 1 (strongly disagree) to 7 (strongly agree).

Receipt of other mental health services and taking of psychotropic medication. Participants will be asked if they are receiving any other mental health/psychiatric services and/or taking any psychotropic medication since they begin the internet-based interventions at post-survey and follow-up survey.

1. Treynor W, Gonzalez R, Nolen-Hoeksema S. Rumination Reconsidered: A Psychometric Analysis, Cognitive Therapy and Research. 2003;27:247-259.

2. Meyer TJ, Miller ML, Metzger RL, Borkovec TD. Development and validation of the Penn State Worry Questionnaire. Behavior Research and Therapy. 1990;28:487-495.

3. Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006;13(1):27-45.

4. Kanter JW, Mulick PS, Busch AM, Berlin KS, Martell CR. The behavioral activation for depression scale (BADS): psychometric properties and factor structure. Journal of Psychopathology and Behavioral Assessment. 2007:29(3):191-202.

5. McLain DL. The MSTAT-I: A new measure of an individual's tolerance for ambiguity. Educational and Psychological Measurement. 1993;53(1):183-189.

No

2015-05-20

ChiCTR-IOR-15006470

2015-05-31

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