Ignite Creation Date:
2024-05-06 @ 1:10 AM
Last Modification Date:
2024-10-26 @ 11:00 AM
Study NCT ID:
NCT01743664
Status:
UNKNOWN
Last Update Posted:
2012-12-07
First Post:
2012-11-21
Brief Title:
The Efficacy of EMDR in Patients With PTSD in Multiple Sclerosis
Sponsor:
San Luigi Gonzaga Hospital
Organization:
San Luigi Gonzaga Hospital
Study Overview
Official Title:
The Efficacy of Eye Movement Desensitization and Reprocessing EMDR in Patients With Post Traumatic Stress Disorder in Multiple Sclerosis A Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2012-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Multiple Sclerosis MS can be associated to many psychological symptoms One of the most relevant is the experience of distress related to the disease that can lead to the development of Post Traumatic Stress Disorder PTSD As far as we know there are no studies on the efficacy of psychological treatments in MS in spite of its relevance for patients quality of life Primary aim is to evaluate the efficacy of the treatment with Eyes Movement Desensitization and ReprocessingEMDR in PTSD secondary to MS EMDR is the elective treatment together with Cognitive Behavioural Therapy for PTSD according to international guidelines The secondary aims are to evaluate the efficacy of EMDR on the PTSD-associated symptoms of anxiety and depression and Quality of Life The study design is a randomized clinical trial Sixty patients with MS and PTSD will be pre-screened by using the IES-R and the Clinician Administered PTSD Scale The patients will be randomized in two groups 30 in the experimental group and 30 in the control groupThe psychological assessment will be performed in both groups with the same timing and tools at baseline T0 after treatment T1 and 6 months later T2 by two trained clinical psychologists independent and blind to treatment with the CAPS and the administration of self reports Trauma Antecedent Questionnaire Chicago Multiscale Depression Inventory Hospital Anxiety and Depression Scale and Functional Assessment of Multiple Sclerosis The experimental group will undergo 10 weekly sessions of 60 minutes each with EMDR following Shapiros protocol for traumatic events The efficacy will be evaluated comparing the results between T0 T1 and T2 and comparing the scores of the experimental and the control groups Primary outcome measures will be 1 the proportion of participants at T1 and T2 no longer meeting the Diagnostic and Statistical Manual DSM IV-TR diagnostic criteria for PTSD 2 the reduction of CAPS scores for the four PTSD dimensions from pre-treatment to post-treatment evaluation and follow-up avoidance reexperiencing the traumatic event hyperarousal and numbing Secondary outcome measures will be comparison of the scores of CMDI HADS and FAMS of the two groups at T0 T1 and T2 The statistical procedure applied will be a repeated measures analysis of covariance both on the primary outcome continuous measures and on the secondary ones
Detailed Description:
Multiple Sclerosis MS is a chronic neurological disease of the Central Nervous System CNS that affects both the brain and the spinal cord by destroying the myelin sheath that protects the nerve fibers leaving plaques or scars on the damaged sites MS shows a wide range of psychological and psychological-related symptoms including psychiatric aspects fatigue and cognitive deficits In particular there is a strong evidence of psychiatric disorders associated with MS the most common being depression adjustment disorder and anxiety These occur more frequently at the time of diagnosis communication during the earlier phases of development of the disease and during relapse episodes Some studies report a significant association between stressful life-events and relapses in some cases pointing to frequency and number of stressors as an enhancing factor that can predict a relapsing episode
The patients may experience distress not only in association with external stressors but also in relation to the onset or the progression of the disease itself Diagnosis relapsing episodes and a worsening of physical functioning may be perceived as traumatic events and may give rise to physiological and emotional posttraumatic symptoms and in some cases to Post Traumatic Stress Disorder PTSD According to the DSM IV-TR PTSD is a clinical condition characterised by the development of characteristic symptoms following exposure to an extreme traumatic stressor involving direct personal experience of an event that involves actual or threatened death or serious injury or other threat to physical integrity The persons response to the event must involve intense fear helplessness The characteristic symptoms resulting from the exposure to the extreme trauma include persistent re-experiencing of the traumatic event persistent avoidance of stimuli associated with the trauma and numbing of general responsiveness and persistent symptoms of increased arousal The full symptom picture must be present for more than one month and the disturbance must cause clinically significant distress or impairment in social occupational or other important areas of functioning DSM IV Many psychological treatments are available for PTSD ranging from individual therapy to family therapy and support groups together with interpersonal relational and psychodynamic psychotherapies their focus is to desensitise the trauma memory and the meaning of the trauma as well as its power to affect relationships Among these therapies the two elective treatments according to international guidelines are the Trauma-focused Cognitive-Behavioural TherapyCBT-TF and Eye Movement Desensitisation and Reprocessing EMDR CBT-TF focuses on thoughts and beliefs helping people to overcome fear about their painful memories by talking about the trauma repeatedly or by imagining the situation that is realistically safe although still frightening EMDR is based on the accelerated information processing model integrating elements of different psychotherapies and it is applied through an eight-phase approach In the EMDR the patient is induced to focus on hisher negative thoughts image and body sensation while receiving an alternate stimulus such as eye movements hand taps or sounds This procedure leads to desensitisation and emotional reprocessing
The aims of the study are aim to evaluate whether a treatment based on the EMDR protocol can resolve PTSD or reduce PTS symptoms also improving the PTS-associated symptoms such as anxiety and depression Primary objective to evaluate the efficacy of the treatment with EMDR on the PTSD in MS Secondary objectives To evaluate whether after treatment with EMDR there is an improvement in PTS-associated symptoms of anxiety and depression and an improvement in quality of life
The recruitment of the patients proceed with a two-step screening 1 the Impact of Event Scale Revised IES-R will be administered to consecutive patients corresponding to the neurological inclusion and exclusion criteria specifying in the instructions that they consider only the illness as the traumatic event 2 Patients with scores above the cut off of 33 will be assessed with the SCID in order to confirm diagnosis of PTSD The research protocol will be proposed to patients with PTSD who meet the inclusionexclusion criteria with an explanation of the aims of the study its relevance for MS patients and the possibility that they may be included by random assignment in the treatment or control group for the period of the study with the same timing and assessment tools If they agree they sign the informed consent Patients will be randomised to the intervention A or control B group using a block-wise randomisation sequence block size of 10 Assessment Measures All patients are evaluated by neurologists with the Expanded Disability Status Scale EDSS
The psychological assessment of the patients entering the study will be performed at T0 baseline evaluation at T1 post-treatment evaluation after 12 weeks and at T2 follow up evaluation six months later to determine the reliability of the results
Measures
CLINICIAN ADMINISTERED PTSD SCALE CAPS the CAPS is a clinical semi-structured interview based on the DSM IV-TR which is the gold standard to assess PTSD It is a 30-item structured interview that meets the DSM IV criteria for PTSD It assesses 4 dimensions of the PTSD avoidance reexperiencing the traumatic event hyperarousal and numbing Dissociative symptoms are measured by the three CAPS dissociation items depersonalization derealization and reduction in awareness of ones surroundings It can be used to make a current past month or life-time diagnosis of PTSD or to assess symptoms over the past week
TRAUMA ANTECEDENT QUESTIONNAIRE TAQ an interview based questionnaire to assess the trauma load due to previous traumas The TAQ asks for the frequency never rarely commonly of experiences assigned to 11 domains ranging from positive experiences like competence and safety to negative experiences such as neglect physical emotional sexual abuse and witnessing trauma separately assess four developmental periods including early childhood 0-6 middle childhood 7-12 adolescence 13 18 and adults 19
CHICAGO MULTISCALE DEPRESSION INVENTORY CMDI the CMDI is a 42-item self-reporting questionnaire and was developed to assess depression in MS and other chronic diseases It has three subscales designed to be used either separately or in combination The mood subscale provides a more conservative indication of depression than total CMDI score and other depression tools
HOSPITAL ANXIETY AND DEPRESSION SCALE HADS the HADS was developed to identify caseness possible and probable of anxiety disorders and depression among patients in non-psychiatric hospital clinics It is divided into an Anxiety subscale HADS-A and a Depression subscale HADS-D both containing seven intermingled items The tool has long been used in studies that involve patients with MS
FAMS Quality of life The FAMS is a factorially derived self-report scale designed to assess six primary aspects of QOL of patients with MS Mobility Symptoms Emotional Well-Being General Contentment Thinking and Fatigue and FamilySocial Well- Being
Treatment The experimental group will undergo 10 sessions of 60 minutes each of treatment with the EMDR protocol The EMDR treatment will be conducted by 3 expert psychotherapists with more than 6 years experience in the liaison setting in possession of II level training degree in EMDR Relaxation techniques RT will be performed by three psychotherapists working in the same facility Treatments will be independent and blinded from the clinical psychologists conducting the clinical assessments
The EMDR protocol follows procedures and phases described by Shapiro 1996 This is a complex treatment that incorporates many different interventions in order to recall trauma-related memories and to subdue them EMDR processing consists of attending to oscillatory stimulation presented in a visual auditory or tactile modalities such as moving the finger from side to side across the patients visual field or presenting an alternating tapping on the hands alternatively Eye movements are the most commonly used external stimulus but if the patient has problems with this kind of stimulation such as headaches or sensomotor deficits the therapist chooses tapping as an alternative form of oscillatory stimulation with equivalent therapeutic efficacy Relaxation sessions will follow the same structure as the EMDR sessions including diaphragmatic breathing progressive muscle relaxation visualisation cue-controlled relaxation and rapid relaxation
The efficacy of the EMDR treatment will be evaluated by comparing the results of the tools CAPS CMDI HADS FAMS administered to the treated group at T0 T1 and T2 and by comparing the scores of the experimental group with those of the control group Primary outcome measures will include 1 Proportion of participants at T1 and T2 no longer meeting the DSM IV-TR diagnostic criteria for PTSD SCID among patients of the experimental group in comparison with those of the control group 2 the reduction of CAPS scores for the four PTSD dimensions from pre-treatment to follow-up in both groups avoidance re-experiencing the traumatic event hyperarousal and numbing
3 Reduction in the IES scores Scores for anxiety depression and quality of life will be included as secondary outcome Dissociative symptoms will be evaluated through the three CAPS dissociation items Taylor et al 2003
Additional expected results the large number of patients assessed for post traumatic symptoms might improve knowledge both of their prevalence and also of the trauma underlying MS Even if it is not the primary aim of the study assessment of the trauma load through the interview-based TAQ will lead to life-trauma evaluation which may be studied for their correlation with the onset of the disease and its emotional correlates Moreover in EMDR associated traumas are defined and treated given that sessions are video-recorded their analysis beyond the three sessions that will be reviewed for treatment fidelity may add knowledge to the role of the trauma load in MS
The patients may experience distress not only in association with external stressors but also in relation to the onset or the progression of the disease itself Diagnosis relapsing episodes and a worsening of physical functioning may be perceived as traumatic events and may give rise to physiological and emotional posttraumatic symptoms and in some cases to Post Traumatic Stress Disorder PTSD According to the DSM IV-TR PTSD is a clinical condition characterised by the development of characteristic symptoms following exposure to an extreme traumatic stressor involving direct personal experience of an event that involves actual or threatened death or serious injury or other threat to physical integrity The persons response to the event must involve intense fear helplessness The characteristic symptoms resulting from the exposure to the extreme trauma include persistent re-experiencing of the traumatic event persistent avoidance of stimuli associated with the trauma and numbing of general responsiveness and persistent symptoms of increased arousal The full symptom picture must be present for more than one month and the disturbance must cause clinically significant distress or impairment in social occupational or other important areas of functioning DSM IV Many psychological treatments are available for PTSD ranging from individual therapy to family therapy and support groups together with interpersonal relational and psychodynamic psychotherapies their focus is to desensitise the trauma memory and the meaning of the trauma as well as its power to affect relationships Among these therapies the two elective treatments according to international guidelines are the Trauma-focused Cognitive-Behavioural TherapyCBT-TF and Eye Movement Desensitisation and Reprocessing EMDR CBT-TF focuses on thoughts and beliefs helping people to overcome fear about their painful memories by talking about the trauma repeatedly or by imagining the situation that is realistically safe although still frightening EMDR is based on the accelerated information processing model integrating elements of different psychotherapies and it is applied through an eight-phase approach In the EMDR the patient is induced to focus on hisher negative thoughts image and body sensation while receiving an alternate stimulus such as eye movements hand taps or sounds This procedure leads to desensitisation and emotional reprocessing
The aims of the study are aim to evaluate whether a treatment based on the EMDR protocol can resolve PTSD or reduce PTS symptoms also improving the PTS-associated symptoms such as anxiety and depression Primary objective to evaluate the efficacy of the treatment with EMDR on the PTSD in MS Secondary objectives To evaluate whether after treatment with EMDR there is an improvement in PTS-associated symptoms of anxiety and depression and an improvement in quality of life
The recruitment of the patients proceed with a two-step screening 1 the Impact of Event Scale Revised IES-R will be administered to consecutive patients corresponding to the neurological inclusion and exclusion criteria specifying in the instructions that they consider only the illness as the traumatic event 2 Patients with scores above the cut off of 33 will be assessed with the SCID in order to confirm diagnosis of PTSD The research protocol will be proposed to patients with PTSD who meet the inclusionexclusion criteria with an explanation of the aims of the study its relevance for MS patients and the possibility that they may be included by random assignment in the treatment or control group for the period of the study with the same timing and assessment tools If they agree they sign the informed consent Patients will be randomised to the intervention A or control B group using a block-wise randomisation sequence block size of 10 Assessment Measures All patients are evaluated by neurologists with the Expanded Disability Status Scale EDSS
The psychological assessment of the patients entering the study will be performed at T0 baseline evaluation at T1 post-treatment evaluation after 12 weeks and at T2 follow up evaluation six months later to determine the reliability of the results
Measures
CLINICIAN ADMINISTERED PTSD SCALE CAPS the CAPS is a clinical semi-structured interview based on the DSM IV-TR which is the gold standard to assess PTSD It is a 30-item structured interview that meets the DSM IV criteria for PTSD It assesses 4 dimensions of the PTSD avoidance reexperiencing the traumatic event hyperarousal and numbing Dissociative symptoms are measured by the three CAPS dissociation items depersonalization derealization and reduction in awareness of ones surroundings It can be used to make a current past month or life-time diagnosis of PTSD or to assess symptoms over the past week
TRAUMA ANTECEDENT QUESTIONNAIRE TAQ an interview based questionnaire to assess the trauma load due to previous traumas The TAQ asks for the frequency never rarely commonly of experiences assigned to 11 domains ranging from positive experiences like competence and safety to negative experiences such as neglect physical emotional sexual abuse and witnessing trauma separately assess four developmental periods including early childhood 0-6 middle childhood 7-12 adolescence 13 18 and adults 19
CHICAGO MULTISCALE DEPRESSION INVENTORY CMDI the CMDI is a 42-item self-reporting questionnaire and was developed to assess depression in MS and other chronic diseases It has three subscales designed to be used either separately or in combination The mood subscale provides a more conservative indication of depression than total CMDI score and other depression tools
HOSPITAL ANXIETY AND DEPRESSION SCALE HADS the HADS was developed to identify caseness possible and probable of anxiety disorders and depression among patients in non-psychiatric hospital clinics It is divided into an Anxiety subscale HADS-A and a Depression subscale HADS-D both containing seven intermingled items The tool has long been used in studies that involve patients with MS
FAMS Quality of life The FAMS is a factorially derived self-report scale designed to assess six primary aspects of QOL of patients with MS Mobility Symptoms Emotional Well-Being General Contentment Thinking and Fatigue and FamilySocial Well- Being
Treatment The experimental group will undergo 10 sessions of 60 minutes each of treatment with the EMDR protocol The EMDR treatment will be conducted by 3 expert psychotherapists with more than 6 years experience in the liaison setting in possession of II level training degree in EMDR Relaxation techniques RT will be performed by three psychotherapists working in the same facility Treatments will be independent and blinded from the clinical psychologists conducting the clinical assessments
The EMDR protocol follows procedures and phases described by Shapiro 1996 This is a complex treatment that incorporates many different interventions in order to recall trauma-related memories and to subdue them EMDR processing consists of attending to oscillatory stimulation presented in a visual auditory or tactile modalities such as moving the finger from side to side across the patients visual field or presenting an alternating tapping on the hands alternatively Eye movements are the most commonly used external stimulus but if the patient has problems with this kind of stimulation such as headaches or sensomotor deficits the therapist chooses tapping as an alternative form of oscillatory stimulation with equivalent therapeutic efficacy Relaxation sessions will follow the same structure as the EMDR sessions including diaphragmatic breathing progressive muscle relaxation visualisation cue-controlled relaxation and rapid relaxation
The efficacy of the EMDR treatment will be evaluated by comparing the results of the tools CAPS CMDI HADS FAMS administered to the treated group at T0 T1 and T2 and by comparing the scores of the experimental group with those of the control group Primary outcome measures will include 1 Proportion of participants at T1 and T2 no longer meeting the DSM IV-TR diagnostic criteria for PTSD SCID among patients of the experimental group in comparison with those of the control group 2 the reduction of CAPS scores for the four PTSD dimensions from pre-treatment to follow-up in both groups avoidance re-experiencing the traumatic event hyperarousal and numbing
3 Reduction in the IES scores Scores for anxiety depression and quality of life will be included as secondary outcome Dissociative symptoms will be evaluated through the three CAPS dissociation items Taylor et al 2003
Additional expected results the large number of patients assessed for post traumatic symptoms might improve knowledge both of their prevalence and also of the trauma underlying MS Even if it is not the primary aim of the study assessment of the trauma load through the interview-based TAQ will lead to life-trauma evaluation which may be studied for their correlation with the onset of the disease and its emotional correlates Moreover in EMDR associated traumas are defined and treated given that sessions are video-recorded their analysis beyond the three sessions that will be reviewed for treatment fidelity may add knowledge to the role of the trauma load in MS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None