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.

Phase 1

• Conditions: Psychological Distress; Emotional Inhibition/Suppression; Immune Function.; Cancer -; Mental Health - Studies of normal psychology, cognitive function and behaviour; Inflammatory and Immune System - Normal development and function of the immune system

• Registration Number: ACTRN12605000783628
• Lead Sponsor: The Cancer Centre, The Royal Adelaide Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-12-08
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 70

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.

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PRIMARY OUTCOME<br>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[Immediately post intervention]

Secondary Outcome Measures

Name	Time	Method
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.[];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.[];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.[]