Ignite Creation Date:
2024-05-06 @ 12:46 PM
Last Modification Date:
2024-10-26 @ 1:04 PM
Study NCT ID:
NCT03848858
Status:
COMPLETED
Last Update Posted:
2022-12-02
First Post:
2018-11-07
Brief Title:
Efficacy of EMDR Therapy as Compared to Treatment as Usual in Reducing Clinical Symptoms in People With HIV
Sponsor:
Parc de Salut Mar
Organization:
Parc de Salut Mar
Study Overview
Official Title:
The Efficacy of Eye Movement Desensitization and Reprocessing Therapy Versus Treatment-As-Usual in a Pilot Randomized Controlled Trial in Reducing Clinical Symptoms and Biological Markers of HIV in Patients With a Recent Diagnosis of HIV
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
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:
People living with HIV may suffer HIV-related psychological trauma Studies also show that this group is vulnerable to non-HIV-related trauma Trauma can increase vulnerability to stress and reducing the ability to cope It can have a negative impact on treatment adherence treatment outcomes functioning and health-related quality of life However despite evidence showing psychological trauma can contribute to poor outcomes in HIV little research has been carried out to assess whether psychological trauma-focused therapy can help people living with HIV
A first-line treatment for psychological trauma is Eye Movement Desensitization and Reprocessing EMDR therapy This therapy is recommended by the World Health Organization for treating Post-Traumatic Stress Disorder with many studies showing this treatment is safe and effective for this disorder However it has not to our knowledge been specifically tested in the population of people living with HIV This project will test whether EMDR therapy in addition to the standard medical treatment received at the Infectious Diseases Unit is more effective than standard medical treatment alone in reducing psychological trauma improving health-related quality of life and improving HIV outcomes in people recently diagnosed with HIV To test this the investigators will recruit 40 people who have received a diagnosis of HIV within the last month 20 will be offered the possibility to receive EMDR treatment for one hour weekly for up to 6 months in addition to the standard medical treatment while the other 20 will be offered only the standard medical treatment The hypotheses of the present study are that the participants who receive EMDR therapy on top of their standard medical treatment will show a reduction in psychological trauma and related symptoms such as anxiety depression and global distress as compared to those who did not The investigators also predict that the EMDR group will show improved functioning and health-related quality of life The final hypotheses are that the EMDR group will show improved treatment adherence and HIV outcomes If this study shows that a psychological trauma-focused therapy can help people adjust to a recent HIV diagnosis and have better outcomes this will have important implications for improving care for people living with HIV
A first-line treatment for psychological trauma is Eye Movement Desensitization and Reprocessing EMDR therapy This therapy is recommended by the World Health Organization for treating Post-Traumatic Stress Disorder with many studies showing this treatment is safe and effective for this disorder However it has not to our knowledge been specifically tested in the population of people living with HIV This project will test whether EMDR therapy in addition to the standard medical treatment received at the Infectious Diseases Unit is more effective than standard medical treatment alone in reducing psychological trauma improving health-related quality of life and improving HIV outcomes in people recently diagnosed with HIV To test this the investigators will recruit 40 people who have received a diagnosis of HIV within the last month 20 will be offered the possibility to receive EMDR treatment for one hour weekly for up to 6 months in addition to the standard medical treatment while the other 20 will be offered only the standard medical treatment The hypotheses of the present study are that the participants who receive EMDR therapy on top of their standard medical treatment will show a reduction in psychological trauma and related symptoms such as anxiety depression and global distress as compared to those who did not The investigators also predict that the EMDR group will show improved functioning and health-related quality of life The final hypotheses are that the EMDR group will show improved treatment adherence and HIV outcomes If this study shows that a psychological trauma-focused therapy can help people adjust to a recent HIV diagnosis and have better outcomes this will have important implications for improving care for people living with HIV
Detailed Description:
Background
The seropositive population are vulnerable to high rates of psychological trauma with 30-40 of people living with HIV having HIV-related trauma and rates of up to 90 of trauma unrelated to HIV HIV-related trauma is linked to various events such as receiving the diagnosis the number of medical symptoms receiving treatment the level of perceived stigma related to HIV and witnessing HIV-related deaths The risk of suffering trauma related to HIV is higher in those with prior trauma and negative life event
Trauma is known to not only have a serious impact on mental health but also to be a key predictor of poor prognosis in HIV affecting treatment outcomes and health-related quality of life Trauma exposure and the development of trauma symptoms impair psychosocial functioning increase vulnerability to stress and burden the physiological systems involved in coping and adaptation Patients with posttraumatic symptoms show poorer treatment adherence yet even in therapy-adherent individuals posttraumatic symptoms are associated with immune dysregulation leading to decreased CD4 cell count and thus negative health outcomes Trauma-affected patients are also more likely to engage in risky health-related behaviors and to suffer higher functional impairment not explained by CD4 count variance
Due to the negative impact of trauma in terms of psychological distress and poorer HIV outcomes psychological interventions which specifically address trauma are needed as an adjunct to antiretroviral treatment in order to reduce unnecessary mortality related to poor treatment adherence and to improve health-related quality of life and functionality There is even potential for psychological interventions to impact directly on HIV disease progression Limited evidence suggests that psychological interventions targeting trauma can have a positive impact on HIV symptom experience while a small but promising body of research into Mindfulness-based interventions targeted at reducing stress show they may have a positive impact on the biological HIV marker CD4 Therefore a brief yet effective psychological intervention at the point of diagnosis could have a significant impact in reducing psychological trauma and distress and improving treatment adherence and thus prognosis and may even improve HIV disease progression
One of the first-line treatments for trauma in non-HIV populations is Eye Movement Desensitization and Reprocessing EMDR therapy EMDR is a psychotherapeutic approach developed in the late 80s by Francine Shapiro that aims to treat traumatic memories and their associated stress symptoms This therapy consists of a standard protocol which includes eight phases and bilateral stimulation usually horizontal saccadic eye movements to desensitize the discomfort caused by traumatic memories and the aim of the therapy is to achieve their reprocessing and integration within the patients standard biographical memories EMDR therapy is recommended by the World Health Organization as a psychotherapy of choice in the treatment of PTSD showing efficacy in children teenagers and adults Recent studies show potential for EMDR as an efficacious treatment in non-PTSD patients including in promoting treatment adherence in bipolar patients and as an add-on treatment in chronic pain conditions as per a recent review Therefore EMDR would seem to be indicated as an interesting therapeutic tool in helping people successfully assimilate the HIV diagnosis and reduce psychological distress and psychological trauma symptoms and as an adjuvant treatment to health-related quality of life and potentially treatment adherence and biological markers of the disease
This study aims to be the first to test the efficacy of the EMDR therapy in people recently diagnosed with HIV If shown to be efficacious in this population it could open the way for future studies to test the efficacy of EMDR in reducing risk behaviors associated with HIV transmission and as a treatment adjunct in treatment-refractory patients
Evaluation Diagnostic Protocol
In the baseline visit sociodemographic data will be taken through a data collection notebook CRD and the validated Spanish versions of clinical scales as well as scales related to health-related quality of life and functionality will be administered At 6 months the measures will be taken again along with a measure regarding satisfaction of the treatment for participants in the EMDR group
Side Effects and Follow Up
EMDR therapy is a safe and well tolerated psychological treatment However some may feel discomfort or suffer when the horizontal eye movements are carried out If this occurs bilateral stimulation will be achieved via tapping which consists of small taps on the hands Likewise therapeutic work on difficult life experiences can accentuate psychological distress symptoms The patient will be taught a variety of self-control techniques to be able to deal with the disturbing information which may arise during and between sessions Any incident will be registered in the patients clinical history as well as the CRD of the investigation project to later report the data
Data Collection Selection and Evaluation of Study Sample
Study participation is voluntary after being informed of the study objectives and having signed the informed consent document The participants will be evaluated individually by specially trained health professionals psychiatrists and psychologists qualified to make diagnoses The project has been sent and approved to the Ethical Committee for Clinical Investigations in our Centre number nº 20188199I Following the baseline evaluation randomization will be carried out stratified by age sex and presence of prior trauma Data will be collected post intervention Motives for refusal to participate in the study will be collected to determine the presence of selection bias in the sample and the causes of non-participation
Statistical Analysis
Calculation of Sample Size
The study aims to evaluate the efficacy of the EMDR intervention protocol with TAU compared to TAU-only in terms of reduction of posttraumatic symptoms and psychological distress and an improvement in functionality health-related quality of life treatment adherence and the biological markers of HIV of CD4 and the CD4CD8 ratio More specifically the study will evaluate the efficacy of the EMDR therapy compared to treatment as usual in patients with HIV and psychological trauma in terms of clinical stabilization and improvement reduction of associated trauma and affective symptoms improvement of functioning health-related quality of life and biological markers This is a pilot study in order to get a signal whether or not this intervention is helpful with a planned sample size of 40 However all patients meeting the inclusion criteria will be assigned to EMDR n20 or the TAU group n20 by two independent researchers using to the following algorithm The first two patients will be randomly allocated to EMDR or TAU For each subsequent patient the treatment allocation will be identified which a balances the arm sizes if one arm has two patients more than the other arm or otherwise b decreases the largest effect-size of the between-arms differences in age sex and trauma type All steps of the randomization process will be automatically carried out in a central location using a computer program Effect sizes will be estimated using Hedges g directly calculated in numeric variables and converted from odds ratios in binary variables
Analysis of the main study variables
The distribution of the between-group socio-demographic and clinical characteristics at baseline will be analyzed using descriptive statistics The continuous variables with a normal distribution will be analyzed with a Multivariate Analysis of Variance MANOVA The change in clinical and biological variables compared to baseline at strategic times during the intervention will be analyzed using an ANOVA with repeated measures including time factors treatment conditions and their interaction For cases which do not meet the normality premise the Wilcoxon test will be used The differences between groups for the categorical and main clinical variables will be analyzed using the Chi-squared test Those variables which are statistically significant can be used as covariables in a logistical regression or lineal study of the factors associated with the significance of the effect and to determine which variables are the best predictors of function The effect size index will be estimated Hedges g or Pearsons r for the correlation index of each analysis carried out The statistical software used for all analyses will be the latest available version of SPSS v 24
Analysis of Clinical Efficacy
For the main statistical analysis the Intention to Treat ITT principal will be applied The Last Observation Carried Forward LOCF will be used as the measure in cases of dropout
Ethical Issues
The current Project will be carried out in accordance with the basic principles of protection of human rights and dignity as per the Helsinki Declaration and as per current legislation The study will not begin until the Ethical Committee for Clinical Investigations CEIC gives approval and all information gathered will be treated confidentially as per EU Regulation 2016679 Patients will be informed verbally and need to sign the attached informed consent
The seropositive population are vulnerable to high rates of psychological trauma with 30-40 of people living with HIV having HIV-related trauma and rates of up to 90 of trauma unrelated to HIV HIV-related trauma is linked to various events such as receiving the diagnosis the number of medical symptoms receiving treatment the level of perceived stigma related to HIV and witnessing HIV-related deaths The risk of suffering trauma related to HIV is higher in those with prior trauma and negative life event
Trauma is known to not only have a serious impact on mental health but also to be a key predictor of poor prognosis in HIV affecting treatment outcomes and health-related quality of life Trauma exposure and the development of trauma symptoms impair psychosocial functioning increase vulnerability to stress and burden the physiological systems involved in coping and adaptation Patients with posttraumatic symptoms show poorer treatment adherence yet even in therapy-adherent individuals posttraumatic symptoms are associated with immune dysregulation leading to decreased CD4 cell count and thus negative health outcomes Trauma-affected patients are also more likely to engage in risky health-related behaviors and to suffer higher functional impairment not explained by CD4 count variance
Due to the negative impact of trauma in terms of psychological distress and poorer HIV outcomes psychological interventions which specifically address trauma are needed as an adjunct to antiretroviral treatment in order to reduce unnecessary mortality related to poor treatment adherence and to improve health-related quality of life and functionality There is even potential for psychological interventions to impact directly on HIV disease progression Limited evidence suggests that psychological interventions targeting trauma can have a positive impact on HIV symptom experience while a small but promising body of research into Mindfulness-based interventions targeted at reducing stress show they may have a positive impact on the biological HIV marker CD4 Therefore a brief yet effective psychological intervention at the point of diagnosis could have a significant impact in reducing psychological trauma and distress and improving treatment adherence and thus prognosis and may even improve HIV disease progression
One of the first-line treatments for trauma in non-HIV populations is Eye Movement Desensitization and Reprocessing EMDR therapy EMDR is a psychotherapeutic approach developed in the late 80s by Francine Shapiro that aims to treat traumatic memories and their associated stress symptoms This therapy consists of a standard protocol which includes eight phases and bilateral stimulation usually horizontal saccadic eye movements to desensitize the discomfort caused by traumatic memories and the aim of the therapy is to achieve their reprocessing and integration within the patients standard biographical memories EMDR therapy is recommended by the World Health Organization as a psychotherapy of choice in the treatment of PTSD showing efficacy in children teenagers and adults Recent studies show potential for EMDR as an efficacious treatment in non-PTSD patients including in promoting treatment adherence in bipolar patients and as an add-on treatment in chronic pain conditions as per a recent review Therefore EMDR would seem to be indicated as an interesting therapeutic tool in helping people successfully assimilate the HIV diagnosis and reduce psychological distress and psychological trauma symptoms and as an adjuvant treatment to health-related quality of life and potentially treatment adherence and biological markers of the disease
This study aims to be the first to test the efficacy of the EMDR therapy in people recently diagnosed with HIV If shown to be efficacious in this population it could open the way for future studies to test the efficacy of EMDR in reducing risk behaviors associated with HIV transmission and as a treatment adjunct in treatment-refractory patients
Evaluation Diagnostic Protocol
In the baseline visit sociodemographic data will be taken through a data collection notebook CRD and the validated Spanish versions of clinical scales as well as scales related to health-related quality of life and functionality will be administered At 6 months the measures will be taken again along with a measure regarding satisfaction of the treatment for participants in the EMDR group
Side Effects and Follow Up
EMDR therapy is a safe and well tolerated psychological treatment However some may feel discomfort or suffer when the horizontal eye movements are carried out If this occurs bilateral stimulation will be achieved via tapping which consists of small taps on the hands Likewise therapeutic work on difficult life experiences can accentuate psychological distress symptoms The patient will be taught a variety of self-control techniques to be able to deal with the disturbing information which may arise during and between sessions Any incident will be registered in the patients clinical history as well as the CRD of the investigation project to later report the data
Data Collection Selection and Evaluation of Study Sample
Study participation is voluntary after being informed of the study objectives and having signed the informed consent document The participants will be evaluated individually by specially trained health professionals psychiatrists and psychologists qualified to make diagnoses The project has been sent and approved to the Ethical Committee for Clinical Investigations in our Centre number nº 20188199I Following the baseline evaluation randomization will be carried out stratified by age sex and presence of prior trauma Data will be collected post intervention Motives for refusal to participate in the study will be collected to determine the presence of selection bias in the sample and the causes of non-participation
Statistical Analysis
Calculation of Sample Size
The study aims to evaluate the efficacy of the EMDR intervention protocol with TAU compared to TAU-only in terms of reduction of posttraumatic symptoms and psychological distress and an improvement in functionality health-related quality of life treatment adherence and the biological markers of HIV of CD4 and the CD4CD8 ratio More specifically the study will evaluate the efficacy of the EMDR therapy compared to treatment as usual in patients with HIV and psychological trauma in terms of clinical stabilization and improvement reduction of associated trauma and affective symptoms improvement of functioning health-related quality of life and biological markers This is a pilot study in order to get a signal whether or not this intervention is helpful with a planned sample size of 40 However all patients meeting the inclusion criteria will be assigned to EMDR n20 or the TAU group n20 by two independent researchers using to the following algorithm The first two patients will be randomly allocated to EMDR or TAU For each subsequent patient the treatment allocation will be identified which a balances the arm sizes if one arm has two patients more than the other arm or otherwise b decreases the largest effect-size of the between-arms differences in age sex and trauma type All steps of the randomization process will be automatically carried out in a central location using a computer program Effect sizes will be estimated using Hedges g directly calculated in numeric variables and converted from odds ratios in binary variables
Analysis of the main study variables
The distribution of the between-group socio-demographic and clinical characteristics at baseline will be analyzed using descriptive statistics The continuous variables with a normal distribution will be analyzed with a Multivariate Analysis of Variance MANOVA The change in clinical and biological variables compared to baseline at strategic times during the intervention will be analyzed using an ANOVA with repeated measures including time factors treatment conditions and their interaction For cases which do not meet the normality premise the Wilcoxon test will be used The differences between groups for the categorical and main clinical variables will be analyzed using the Chi-squared test Those variables which are statistically significant can be used as covariables in a logistical regression or lineal study of the factors associated with the significance of the effect and to determine which variables are the best predictors of function The effect size index will be estimated Hedges g or Pearsons r for the correlation index of each analysis carried out The statistical software used for all analyses will be the latest available version of SPSS v 24
Analysis of Clinical Efficacy
For the main statistical analysis the Intention to Treat ITT principal will be applied The Last Observation Carried Forward LOCF will be used as the measure in cases of dropout
Ethical Issues
The current Project will be carried out in accordance with the basic principles of protection of human rights and dignity as per the Helsinki Declaration and as per current legislation The study will not begin until the Ethical Committee for Clinical Investigations CEIC gives approval and all information gathered will be treated confidentially as per EU Regulation 2016679 Patients will be informed verbally and need to sign the attached informed consent
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None