University of Melbourne
Melbourne School of Psychological Sciences

Author Of 1 Presentation

Clinical Trials Poster Presentation

P0185 - A phase II randomised controlled trial of a cognitive behavioral therapy intervention for depression in those newly diagnosed with MS (ID 1578)

Speakers
Presentation Number
P0185
Presentation Topic
Clinical Trials

Abstract

Background

Depression is a serious and co-morbid condition of MS. Up to 50% of individuals with MS experience clinically significant levels of depressive symptoms at any one time (Arnett et al., 2008). Depression and anxiety are especially high after diagnosis (Giordano et al., 2011; Kiropoulos et al., 2016) with 36% of individuals found to report high levels of depressive symptoms in the first years after diagnosis (Jensens et al., 2003). Cogntitive Behaviour Therapy (CBT) has shown to be effective in reducing symptoms of depression in those with MS (Kiropoulos et al., 2016) with the current study being the first RCT examining the effectiveness of a tailored cognitive behavioural therapy (CBT) intervention, compared to a supportive listening (SL) intervention, for depression in those who have been newly diagnosed with MS (within 5 years of having received a MS diagnosis).

Objectives

To assess efficacy of an early tailored CBT intervention, compared to SL, in producing significant and clinically meaningful reductions in: 1) depressive symptoms; 2) anxiety symptoms and 3) MS-related concerns (such as fatigue, sleep disturbance, pain impact). And to: 4) increase physical and mental health related quality of life, MS illness acceptance, social support, coping and resilience; and 5) to assess cost-effectiveness of providing the CBT intervention. An additional aim is to measure and examine changes in levels of cytokines before and after the interventions.

Methods

This is a two arm, parallel group, active comparator, assessor blinded RCT with the primary site being the Royal Melbourne Hospital. Recruitment is also being undertaken from three major MS clinics located in Melbourne, Victoria. 60 participants are being randomly allocated to a tailored CBT(n=30) or SL (n=30) intervention. 8 x 1 hour interventions will be delivered over 8 weeks by clinical psychologists for both treatment arms. Self-report and clinician data is and will be collected at pre, post and 3 mth follow up time points. Eligibility criteria includes mild to moderately depressed individuals newly diagnosed (within first 5 years of diagnosis) with MS. Exclusion criteria includes gross cognitive impairment; serious psychological disorder; delirium; undertaking psychological treatment for depression; unable to speak or read English.

Results

Preliminary results will be presented for the primary outcome which is the level of clinically significant change of 10 points or more on the BDI-2 at post therapy, secondary outcomes which are the level of depression at 3 mths and level of anxiety at post-assessment and tertiary outcomes which are the level of anxiety at 3 mths follow up, pain and fatigue impact, MS illness acceptance, sleep quality, coping, social support, resilience at post and 3 mth follow up.

Conclusions

Conclusions will be provided relating to the effectiveness of the CBT intervention in the treatment of depression in individuals newly diagnosed with MS.

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Presenter Of 1 Presentation

Clinical Trials Poster Presentation

P0185 - A phase II randomised controlled trial of a cognitive behavioral therapy intervention for depression in those newly diagnosed with MS (ID 1578)

Speakers
Presentation Number
P0185
Presentation Topic
Clinical Trials

Abstract

Background

Depression is a serious and co-morbid condition of MS. Up to 50% of individuals with MS experience clinically significant levels of depressive symptoms at any one time (Arnett et al., 2008). Depression and anxiety are especially high after diagnosis (Giordano et al., 2011; Kiropoulos et al., 2016) with 36% of individuals found to report high levels of depressive symptoms in the first years after diagnosis (Jensens et al., 2003). Cogntitive Behaviour Therapy (CBT) has shown to be effective in reducing symptoms of depression in those with MS (Kiropoulos et al., 2016) with the current study being the first RCT examining the effectiveness of a tailored cognitive behavioural therapy (CBT) intervention, compared to a supportive listening (SL) intervention, for depression in those who have been newly diagnosed with MS (within 5 years of having received a MS diagnosis).

Objectives

To assess efficacy of an early tailored CBT intervention, compared to SL, in producing significant and clinically meaningful reductions in: 1) depressive symptoms; 2) anxiety symptoms and 3) MS-related concerns (such as fatigue, sleep disturbance, pain impact). And to: 4) increase physical and mental health related quality of life, MS illness acceptance, social support, coping and resilience; and 5) to assess cost-effectiveness of providing the CBT intervention. An additional aim is to measure and examine changes in levels of cytokines before and after the interventions.

Methods

This is a two arm, parallel group, active comparator, assessor blinded RCT with the primary site being the Royal Melbourne Hospital. Recruitment is also being undertaken from three major MS clinics located in Melbourne, Victoria. 60 participants are being randomly allocated to a tailored CBT(n=30) or SL (n=30) intervention. 8 x 1 hour interventions will be delivered over 8 weeks by clinical psychologists for both treatment arms. Self-report and clinician data is and will be collected at pre, post and 3 mth follow up time points. Eligibility criteria includes mild to moderately depressed individuals newly diagnosed (within first 5 years of diagnosis) with MS. Exclusion criteria includes gross cognitive impairment; serious psychological disorder; delirium; undertaking psychological treatment for depression; unable to speak or read English.

Results

Preliminary results will be presented for the primary outcome which is the level of clinically significant change of 10 points or more on the BDI-2 at post therapy, secondary outcomes which are the level of depression at 3 mths and level of anxiety at post-assessment and tertiary outcomes which are the level of anxiety at 3 mths follow up, pain and fatigue impact, MS illness acceptance, sleep quality, coping, social support, resilience at post and 3 mth follow up.

Conclusions

Conclusions will be provided relating to the effectiveness of the CBT intervention in the treatment of depression in individuals newly diagnosed with MS.

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