Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000783628
Ethics application status
Approved
Date submitted
7/12/2005
Date registered
8/12/2005
Date last updated
19/01/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
An Extension of the Written Disclosure Paradigm to the Psychotherapeutic Context: Can Systematic Changes in Emotion Regulation Strategy Reduce Distress and Improve Immune Function in Cancer Patients Living in Remission.
Scientific title
Evaluation of the Efficacy of Emotion Focused Psychotherapies for Reducing Distress and Improving Immune Function and Quality of Life in Cancer Patients Living in Remission.
Universal Trial Number (UTN)
Trial acronym
EEFP1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychological Distress 940 0
Emotional Inhibition/Suppression 941 0
Immune Function. 942 0
Condition category
Condition code
Cancer 1009 1009 0 0
Mental Health 1010 1010 0 0
Studies of normal psychology, cognitive function and behaviour
Inflammatory and Immune System 1011 1011 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In the first of three studies that aim to the efficacy of psychotherapies focused on the expression of emotion, Pennebaker & Beal's (1986) written disclosure methodology will be applied to an individual psychotherapeutic context. In an extension of the Pennebaker & Beal (1986) paradigm; and in accord with recent theoretical developments (i.e., A to D Emotion Theory; Pennebaker & Chung (In-Press)), Participants allocated to the Treatment group will be encouraged to use emotion labels when expressing their deepest thoughts and feelings with respect to the following topics: Diagnosis (weeks 1 & 6); Treatment/Waiting for Results (weeks 2 & 7); Living in Remission (weeks 3 & 8); Most Distressing/Traumatic Experience (weeks 4 & 5). Participants randomly allocated to the Treatment group will attend 8 x 1 hour, individual sessions.
Intervention code [1] 791 0
None
Comparator / control treatment
The Control group will continue to receive routine care from their respective health care professionals.
Control group
Active

Outcomes
Primary outcome [1] 1348 0
PRIMARY OUTCOME
1. At Time 2 (i.e. immediately post intervention) there will be a 50% decrease in GHQ 12 (General Health Questionnaire; Goldberg, 1992) scores from a Mean of 5.76 in the control group to a Mean of 2.88 in the intervention group, with a common standard deviation of 3.04, with at least 80% power at the 5% significance level
Timepoint [1] 1348 0
Immediately post intervention
Secondary outcome [1] 2399 0
1. At time 2, there will be a 25% increase in NT (lymphocytic-ectonucleotidase) from a Mean of 0.55 in the control group to a Mean of 0.68 in the intervention group, with a common standard deviation of 0.19 (Blake-Mortimer, Winefield & Chalmers, 1996), with 80% power at the 5% significance level.
Timepoint [1] 2399 0
Secondary outcome [2] 2400 0
2. At time 2, there will be a 25% decrease in suppression (measured by the Courtauld Emotional Suppression Scale; Watson et al., 1983 ) from a Mean of 49.17 in the control group to a Mean of 36.87 in the intervention group, with a common standard deviation of 13.45 (Giese-Davis et al., 2002),with at least 80% power at the 5% significance level.
Timepoint [2] 2400 0
Secondary outcome [3] 2401 0
3. At Time 2, there will be a 25% increase in Emotional Approach Coping (EAC; Stanton, 2002) from a Mean of 2.59 in the control group to a Mean of 3.23 in the intervention group, with a common standard deviation of 0.8 (Stanton, 2002), with at least 80% power at the 5% significance level.
Timepoint [3] 2401 0

Eligibility
Key inclusion criteria
Received a diagnosis of Stage I, or II cancer (solid neoplasm) within the past 12 months. Score more than 4 using the General Health Questionnaire (GHQ-12).A minimum of two months must have elapsed since surgery, chemotherapy or radiation therapy. Be able to speak fluent English, have no apparent intellectual impairment.Reside within the Adelaide metropolitan area and be able to attend psychotherapy sessions on a weekly basis (for 1 hour) over an 8 week period.
Minimum age
18 Years
Maximum age
74 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A diagnosis of Heart Disease, Diabetes, Rheumatoid Arthritis, Addisons disease, Cushings Disease or Lupus.Are taking medication that suppresses the immune system, are pregnant or breast feeding.Have an infectious disease such as HIV, HBV, HCV.DSM-IV diagnosis of psychotic disorder.GHQ score less than 4.Are physically unwell at the time of testing, and/or are physically unable to attend trial. Participated in a previous emotion focused psychotherapy trial.

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)
The Randomisation to control and intervention groups will be handled by administrative personnel at the Royal Adelaide Hospital, to ensure researchers involved in the trials are removed from this process. Given the nature of the study, however, it is not possible to conceal whether or not one receives psychotherapy.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Administrative personnel at the Royal Adelaide Hospital will use the facility available on the Microsoft Excel Program to allocate Participants to the Routine Care Group or the Treatment Group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/01/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1114 0
Hospital
Name [1] 1114 0
The Cancer Centre, The Royal Adelaide Hospital
Country [1] 1114 0
Australia
Funding source category [2] 1115 0
University
Name [2] 1115 0
The Psychology Department, The University of Adelaide
Country [2] 1115 0
Australia
Primary sponsor type
Hospital
Name
The Cancer Centre, The Royal Adelaide Hospital
Address
Country
Australia
Secondary sponsor category [1] 973 0
University
Name [1] 973 0
The Psychology Department, The University of Adelaide.
Address [1] 973 0
Country [1] 973 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2422 0
The Royal Adelaide Hospital
Ethics committee address [1] 2422 0
Ethics committee country [1] 2422 0
Australia
Date submitted for ethics approval [1] 2422 0
Approval date [1] 2422 0
Ethics approval number [1] 2422 0
Ethics committee name [2] 2423 0
The Repatriation General Hospital
Ethics committee address [2] 2423 0
Ethics committee country [2] 2423 0
Australia
Date submitted for ethics approval [2] 2423 0
Approval date [2] 2423 0
Ethics approval number [2] 2423 0
Ethics committee name [3] 2424 0
The Flinders Medical Centre
Ethics committee address [3] 2424 0
Ethics committee country [3] 2424 0
Australia
Date submitted for ethics approval [3] 2424 0
Approval date [3] 2424 0
Ethics approval number [3] 2424 0

Summary
Brief summary
Full ethical approval to proceed with the project has been given by all Institutions described above.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35260 0
Address 35260 0
Country 35260 0
Phone 35260 0
Fax 35260 0
Email 35260 0
Contact person for public queries
Name 9980 0
Vikki Knott
Address 9980 0
Department of Psychology
University of Adelaide
Level 4
Hughes Building
Adelaide SA 5005
Country 9980 0
Australia
Phone 9980 0
+61 8 83036785
Fax 9980 0
+61 8 83033770
Email 9980 0
[email protected]
Contact person for scientific queries
Name 908 0
Vikki Knott
Address 908 0
Department of Psychology
University of Adelaide
Level 4
Hughes Building
Adelaide SA 5005
Country 908 0
Australia
Phone 908 0
+61 8 83036785
Fax 908 0
+61 8 83033770
Email 908 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.