Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00650

2 Trial Registration Date

2018-12-28

i Registration Status

Prospective

3 Secondary IDs

N/A

4 Source(s) of Funding

N/A

5 Primary Sponsor

N/A

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Silvia Lee

ii Address

Castle Peak Hospital,
15 Tsing Chung Kwun Road,
Tuen Mun, N.T.
Hong Kong

iii Phone

2456 8909

iv Email

1006362900@link.cuhk.edu.hk

v Affiliation

Clinical Psychologist

vi Country

Hong Kong

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Lee Sze Wai

ii Address

Castle Peak Hospital,
15 Tsing Chung Kwun Road,
Tuen Mun, N.T.
Hong Kong

iii Phone

24568909

iv Email

leeszewai@gmail.com

v Affiliation

Department of Psychology, The Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

An open uncontrolled trial of Imagery Rescripting for Depression

10 Public Title

Research on Imagery Rescripting for Depression

i Public Title in Chinese 研究名稱

抑鬱症意象重組治療研究計劃

11 Short Title (Optional)

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2018-11-30

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2018.362

14 Medical Condition Being Studied

Depression

15 Intervention

i Types of intervention

Behavior

Please specify

ii Description/ name of Intervention/article

Imagery Rescripting

iii Dosage form of the intervention

Psychological treatment session

iv Dosage of the intervention

4-12 sessions

v Duration of the intervention

4-12 weeks

vi Frequency of the intervention

once weekly

16 Comparative Treatments

i Description/ name of comparative treatments

N/A

ii Dosage form of the comparative treatments

N/A

iii Dosage of the comparative treatments

N/A

iv Duration of the comparative treatments

N/A

v Frequency of the comparative treatments

N/A

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Age between 18-65

Use Chinese as primary written language

Primary diagnosis is Major Depressive Disorder

Experienced involuntary negative memory of at least one significant event in the past month

ii Exclusion Criteria

Diagnoses of psychotic disorders, organic brain disease, current substance abuse or intellectual disability

Diagnoses of Post-traumatic Stress Disorder, Dissociative Disorders and Personality Disorders

In high risk of self-harm or suicide

Unable to give informed consent

Undergoing concurrent psychotherapy, or in medication adjustment phase

iii Age Minimum

18

iv Age Maximum

65

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Not Applicable

Please specify

ii Nature of control

Uncontrolled

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Single group

v Study Phase

2

Please specify

vi Study Objectives (Optional)

To test the effectiveness of Imagery Rescripting as an intervention for depression

20 Anticipated trial start date

2018-12-29

21 Target Sample Size

26

22 Recruitment Status

Recruiting

23 Primary Outcome

i The Name of the outcome

Diagnosis of Depression

ii The metric or method of measurement used

The M.I.N.I. International Neuropsychiatric Interview (M.I.N.I. 7.0.2)(Sheehan et al., 1998)

iii The timepoint(s) of primary interest

Pre-treatment and post-treatment

Primary Outcome

i The Name of the outcome

Symptoms of Depression

ii The metric or method of measurement used

Chinese Version of the Beck Depression Inventory-II (C-BDI-II) ( Chinese Behavioral Sciences Society, 2000)

iii The timepoint(s) of primary interest

Pre-treatment, post-treatment and at 3-months follow-up

Primary Outcome

i The Name of the outcome

Intrusive Memories

ii The metric or method of measurement used

Intrusive Memories Interview (Patel et al, 2007)

iii The timepoint(s) of primary interest

Pre-treatment, every session, post-treatment and at 3-months follow-up

24 Secondary Outcome

i The Name of the outcome

Rumination

ii The metric or method of measurement used

Chinese version of The Rumination Response Scale (RRS; Nolen-Hoeksema & Morrow, 1991; Lo, Ho & Hollon, 2008)

iii The timepoint(s) of primary interest

Pre-treatment, post-treatment and at 3-months follow-up.

Secondary Outcome

i The Name of the outcome

Symptoms of Depression

ii The metric or method of measurement used

Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2001)

iii The timepoint(s) of primary interest

Pre-treatment, every session, post-treatment and at 3-months follow-up

Secondary Outcome

i The Name of the outcome

Symptoms of Anxiety

ii The metric or method of measurement used

Generalized Anxiety Disorder 7 (GAD-7; Spitzer, Kroenke, Williams, & Löwe, 2006)

iii The timepoint(s) of primary interest

Pre-treatment, every session, post-treatment and at 3-months follow-up

Secondary Outcome

i The Name of the outcome

Self-compassion

ii The metric or method of measurement used

Self-compassion scale-short form (Raes, Pommier, Neff, Van Gucht, 2011)

iii The timepoint(s) of primary interest

Pre-treatment, every session, post-treatment and at 3-months follow-up

Secondary Outcome

i The Name of the outcome

Subjective Satisfaction towards treatment

ii The metric or method of measurement used

Subjective Satisfaction towards treatment scale

iii The timepoint(s) of primary interest

Post-treatment only

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2021-03-19

27 Primary Registry and Trial Identifying Number

ChiCTR1900021047

28 Date of Registration in Primary Registry

2018-12-28

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Trial History Detail on 2020-01-30