Improving treatment for patients with childhood abuse related posttraumatic stress disorder (IMPACT study): protocol for a multicenter randomized trial comparing prolonged exposure with intensified prolonged exposure and phase-based treatment.
Identifieur interne : 000569 ( Main/Corpus ); précédent : 000568; suivant : 000570Improving treatment for patients with childhood abuse related posttraumatic stress disorder (IMPACT study): protocol for a multicenter randomized trial comparing prolonged exposure with intensified prolonged exposure and phase-based treatment.
Auteurs : D A C. Oprel ; C M Hoeboer ; M. Schoorl ; R A De Kleine ; I G Wigard ; M. Cloitre ; A. Van Minnen ; W. Van Der DoesSource :
- BMC psychiatry [ 1471-244X ] ; 2018.
English descriptors
- KwdEn :
- Adult (MeSH), Adult Survivors of Child Abuse (psychology), Female (MeSH), Humans (MeSH), Implosive Therapy (methods), Psychiatric Status Rating Scales (MeSH), Quality of Life (MeSH), Reproducibility of Results (MeSH), Stress Disorders, Post-Traumatic (etiology), Stress Disorders, Post-Traumatic (psychology), Stress Disorders, Post-Traumatic (therapy), Treatment Outcome (MeSH).
- MESH :
- etiology : Stress Disorders, Post-Traumatic.
- methods : Implosive Therapy.
- psychology : Adult Survivors of Child Abuse, Stress Disorders, Post-Traumatic.
- therapy : Stress Disorders, Post-Traumatic.
- Adult, Female, Humans, Psychiatric Status Rating Scales, Quality of Life, Reproducibility of Results, Treatment Outcome.
Abstract
BACKGROUND
Childhood abuse related posttraumatic stress disorder (CA-PTSD) is associated with a high burden of disease and with treatment response rates that leave room for improvement. One of the treatments for PTSD, prolonged exposure (PE), is effective but has high drop-out rates and remission rates are relatively low. An intensified form of PE (iPE) was associated with good response and low drop-out rates in PTSD and has not yet been tested in a controlled trial in CA-PTSD. Phase-based treatment (PBT), in which PE is preceded by skills training may improve overall outcomes in this population. We will assess the effectiveness and cost-effectiveness of standard PE, iPE and PBT in patients with CA-PTSD.
METHODS/DESIGN
Multi-center randomized controlled trial. Treatment conditions are: prolonged exposure (PE; maximum of 16 sessions in 16 weeks); intensified PE (iPE; maximum of 12 sessions in four weeks and two booster sessions); phase-based treatment (PBT; maximum of eight sessions skills training followed by eight sessions PE in 16 weeks).
PRIMARY OUTCOME
Clinician-rated PTSD symptom severity.
SECONDARY OUTCOMES
loss of PTSD diagnosis, self-reported PTSD symptom severity, comorbid symptom severity and quality of life. Moreover, we will examine cost-effectiveness and moderators and mediators of treatment outcome.
TARGET POPULATION
adults with CA-PTSD (N = 150). Assessments in weeks 0, 4, 8, 16, 26 and 52.
DISCUSSION
Given that no consensus yet exists about the treatment guidelines for patients with CA-PTSD, the present study may have important implications for the treatment of CA-PTSD.
TRAIL REGISTRATION
Registered at C.C.M.O. on Sept 7, 2016 (NL57984.058.16); retrospectively registered at June 21, 2017 at clinicaltrials.gov identifier: NCT03194113 .
DOI: 10.1186/s12888-018-1967-5
PubMed: 30541492
PubMed Central: PMC6291949
Links to Exploration step
pubmed:30541492Le document en format XML
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Oprel</name><affiliation><nlm:affiliation>Leiden University, Institute of Psychology, Wassenaarsweg 22, 3332, AK, Leiden, The Netherlands.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Parnassiagroep, PsyQ, Lijnbaan 4, 2512, VA, The Hague, The Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Hoeboer, C M" sort="Hoeboer, C M" uniqKey="Hoeboer C" first="C M" last="Hoeboer">C M Hoeboer</name><affiliation><nlm:affiliation>Leiden University, Institute of Psychology, Wassenaarsweg 22, 3332, AK, Leiden, The Netherlands.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Parnassiagroep, PsyQ, Lijnbaan 4, 2512, VA, The Hague, The Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Schoorl, M" sort="Schoorl, M" uniqKey="Schoorl M" first="M" last="Schoorl">M. Schoorl</name><affiliation><nlm:affiliation>Leiden University, Institute of Psychology, Wassenaarsweg 22, 3332, AK, Leiden, The Netherlands. m.schoorl@fsw.leidenuniv.nl.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Parnassiagroep, PsyQ, Lijnbaan 4, 2512, VA, The Hague, The Netherlands. m.schoorl@fsw.leidenuniv.nl.</nlm:affiliation></affiliation></author><author><name sortKey="De Kleine, R A" sort="De Kleine, R A" uniqKey="De Kleine R" first="R A" last="De Kleine">R A De Kleine</name><affiliation><nlm:affiliation>Leiden University, Institute of Psychology, Wassenaarsweg 22, 3332, AK, Leiden, The Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Wigard, I G" sort="Wigard, I G" uniqKey="Wigard I" first="I G" last="Wigard">I G Wigard</name><affiliation><nlm:affiliation>Parnassiagroep, PsyQ, Lijnbaan 4, 2512, VA, The Hague, The Netherlands.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Clinical Psychology, University of Amsterdam, Overschiestraat 61, 1062, XD, Amsterdam, The Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Cloitre, M" sort="Cloitre, M" uniqKey="Cloitre M" first="M" last="Cloitre">M. Cloitre</name><affiliation><nlm:affiliation>Department of Psychiatry and Behavioral Sciences, Stanford University, Palo Alto, CA, USA.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>National Center for PTSD Dissemination and Training Division, Palo Alto Veterans Affairs Palo Alto Health Care System, 795 Willow Road, Menlo Park, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Van Minnen, A" sort="Van Minnen, A" uniqKey="Van Minnen A" first="A" last="Van Minnen">A. Van Minnen</name><affiliation><nlm:affiliation>PSYTREC, Prof. dr. Bronkhorststraat 2, 3723, MB, Bilthoven, The Netherlands.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Radboud University, Behavioural Science Institute, Nijmegen, The Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Van Der Does, W" sort="Van Der Does, W" uniqKey="Van Der Does W" first="W" last="Van Der Does">W. Van Der Does</name><affiliation><nlm:affiliation>Leiden University, Institute of Psychology, Wassenaarsweg 22, 3332, AK, Leiden, The Netherlands.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Parnassiagroep, PsyQ, Lijnbaan 4, 2512, VA, The Hague, The Netherlands.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Psychiatry, Leiden University Medical Center, Leiden, The Netherlands.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2018">2018</date><idno type="RBID">pubmed:30541492</idno><idno type="pmid">30541492</idno><idno type="doi">10.1186/s12888-018-1967-5</idno><idno type="pmc">PMC6291949</idno><idno type="wicri:Area/Main/Corpus">000569</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">000569</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Improving treatment for patients with childhood abuse related posttraumatic stress disorder (IMPACT study): protocol for a multicenter randomized trial comparing prolonged exposure with intensified prolonged exposure and phase-based treatment.</title><author><name sortKey="Oprel, D A C" sort="Oprel, D A C" uniqKey="Oprel D" first="D A C" last="Oprel">D A C. Oprel</name><affiliation><nlm:affiliation>Leiden University, Institute of Psychology, Wassenaarsweg 22, 3332, AK, Leiden, The Netherlands.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Parnassiagroep, PsyQ, Lijnbaan 4, 2512, VA, The Hague, The Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Hoeboer, C M" sort="Hoeboer, C M" uniqKey="Hoeboer C" first="C M" last="Hoeboer">C M Hoeboer</name><affiliation><nlm:affiliation>Leiden University, Institute of Psychology, Wassenaarsweg 22, 3332, AK, Leiden, The Netherlands.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Parnassiagroep, PsyQ, Lijnbaan 4, 2512, VA, The Hague, The Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Schoorl, M" sort="Schoorl, M" uniqKey="Schoorl M" first="M" last="Schoorl">M. Schoorl</name><affiliation><nlm:affiliation>Leiden University, Institute of Psychology, Wassenaarsweg 22, 3332, AK, Leiden, The Netherlands. m.schoorl@fsw.leidenuniv.nl.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Parnassiagroep, PsyQ, Lijnbaan 4, 2512, VA, The Hague, The Netherlands. m.schoorl@fsw.leidenuniv.nl.</nlm:affiliation></affiliation></author><author><name sortKey="De Kleine, R A" sort="De Kleine, R A" uniqKey="De Kleine R" first="R A" last="De Kleine">R A De Kleine</name><affiliation><nlm:affiliation>Leiden University, Institute of Psychology, Wassenaarsweg 22, 3332, AK, Leiden, The Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Wigard, I G" sort="Wigard, I G" uniqKey="Wigard I" first="I G" last="Wigard">I G Wigard</name><affiliation><nlm:affiliation>Parnassiagroep, PsyQ, Lijnbaan 4, 2512, VA, The Hague, The Netherlands.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Clinical Psychology, University of Amsterdam, Overschiestraat 61, 1062, XD, Amsterdam, The Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Cloitre, M" sort="Cloitre, M" uniqKey="Cloitre M" first="M" last="Cloitre">M. Cloitre</name><affiliation><nlm:affiliation>Department of Psychiatry and Behavioral Sciences, Stanford University, Palo Alto, CA, USA.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>National Center for PTSD Dissemination and Training Division, Palo Alto Veterans Affairs Palo Alto Health Care System, 795 Willow Road, Menlo Park, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Van Minnen, A" sort="Van Minnen, A" uniqKey="Van Minnen A" first="A" last="Van Minnen">A. Van Minnen</name><affiliation><nlm:affiliation>PSYTREC, Prof. dr. Bronkhorststraat 2, 3723, MB, Bilthoven, The Netherlands.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Radboud University, Behavioural Science Institute, Nijmegen, The Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Van Der Does, W" sort="Van Der Does, W" uniqKey="Van Der Does W" first="W" last="Van Der Does">W. Van Der Does</name><affiliation><nlm:affiliation>Leiden University, Institute of Psychology, Wassenaarsweg 22, 3332, AK, Leiden, The Netherlands.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Parnassiagroep, PsyQ, Lijnbaan 4, 2512, VA, The Hague, The Netherlands.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Psychiatry, Leiden University Medical Center, Leiden, The Netherlands.</nlm:affiliation></affiliation></author></analytic><series><title level="j">BMC psychiatry</title><idno type="eISSN">1471-244X</idno><imprint><date when="2018" type="published">2018</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult (MeSH)</term><term>Adult Survivors of Child Abuse (psychology)</term><term>Female (MeSH)</term><term>Humans (MeSH)</term><term>Implosive Therapy (methods)</term><term>Psychiatric Status Rating Scales (MeSH)</term><term>Quality of Life (MeSH)</term><term>Reproducibility of Results (MeSH)</term><term>Stress Disorders, Post-Traumatic (etiology)</term><term>Stress Disorders, Post-Traumatic (psychology)</term><term>Stress Disorders, Post-Traumatic (therapy)</term><term>Treatment Outcome (MeSH)</term></keywords><keywords scheme="MESH" qualifier="etiology" xml:lang="en"><term>Stress Disorders, Post-Traumatic</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Implosive Therapy</term></keywords><keywords scheme="MESH" qualifier="psychology" xml:lang="en"><term>Adult Survivors of Child Abuse</term><term>Stress Disorders, Post-Traumatic</term></keywords><keywords scheme="MESH" qualifier="therapy" xml:lang="en"><term>Stress Disorders, Post-Traumatic</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Female</term><term>Humans</term><term>Psychiatric Status Rating Scales</term><term>Quality of Life</term><term>Reproducibility of Results</term><term>Treatment Outcome</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>BACKGROUND</b></p><p>Childhood abuse related posttraumatic stress disorder (CA-PTSD) is associated with a high burden of disease and with treatment response rates that leave room for improvement. One of the treatments for PTSD, prolonged exposure (PE), is effective but has high drop-out rates and remission rates are relatively low. An intensified form of PE (iPE) was associated with good response and low drop-out rates in PTSD and has not yet been tested in a controlled trial in CA-PTSD. Phase-based treatment (PBT), in which PE is preceded by skills training may improve overall outcomes in this population. We will assess the effectiveness and cost-effectiveness of standard PE, iPE and PBT in patients with CA-PTSD.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS/DESIGN</b></p><p>Multi-center randomized controlled trial. Treatment conditions are: prolonged exposure (PE; maximum of 16 sessions in 16 weeks); intensified PE (iPE; maximum of 12 sessions in four weeks and two booster sessions); phase-based treatment (PBT; maximum of eight sessions skills training followed by eight sessions PE in 16 weeks).</p></div><div type="abstract" xml:lang="en"><p><b>PRIMARY OUTCOME</b></p><p>Clinician-rated PTSD symptom severity.</p></div><div type="abstract" xml:lang="en"><p><b>SECONDARY OUTCOMES</b></p><p>loss of PTSD diagnosis, self-reported PTSD symptom severity, comorbid symptom severity and quality of life. Moreover, we will examine cost-effectiveness and moderators and mediators of treatment outcome.</p></div><div type="abstract" xml:lang="en"><p><b>TARGET POPULATION</b></p><p>adults with CA-PTSD (N = 150). Assessments in weeks 0, 4, 8, 16, 26 and 52.</p></div><div type="abstract" xml:lang="en"><p><b>DISCUSSION</b></p><p>Given that no consensus yet exists about the treatment guidelines for patients with CA-PTSD, the present study may have important implications for the treatment of CA-PTSD.</p></div><div type="abstract" xml:lang="en"><p><b>TRAIL REGISTRATION</b></p><p>Registered at C.C.M.O. on Sept 7, 2016 (NL57984.058.16); retrospectively registered at June 21, 2017 at clinicaltrials.gov identifier: NCT03194113 .</p></div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" IndexingMethod="Curated" Owner="NLM"><PMID Version="1">30541492</PMID><DateCompleted><Year>2019</Year><Month>09</Month><Day>16</Day></DateCompleted><DateRevised><Year>2020</Year><Month>03</Month><Day>09</Day></DateRevised><Article PubModel="Electronic"><Journal><ISSN IssnType="Electronic">1471-244X</ISSN><JournalIssue CitedMedium="Internet"><Volume>18</Volume><Issue>1</Issue><PubDate><Year>2018</Year><Month>12</Month><Day>12</Day></PubDate></JournalIssue><Title>BMC psychiatry</Title><ISOAbbreviation>BMC Psychiatry</ISOAbbreviation></Journal><ArticleTitle>Improving treatment for patients with childhood abuse related posttraumatic stress disorder (IMPACT study): protocol for a multicenter randomized trial comparing prolonged exposure with intensified prolonged exposure and phase-based treatment.</ArticleTitle><Pagination><MedlinePgn>385</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1186/s12888-018-1967-5</ELocationID><Abstract><AbstractText Label="BACKGROUND">Childhood abuse related posttraumatic stress disorder (CA-PTSD) is associated with a high burden of disease and with treatment response rates that leave room for improvement. One of the treatments for PTSD, prolonged exposure (PE), is effective but has high drop-out rates and remission rates are relatively low. An intensified form of PE (iPE) was associated with good response and low drop-out rates in PTSD and has not yet been tested in a controlled trial in CA-PTSD. Phase-based treatment (PBT), in which PE is preceded by skills training may improve overall outcomes in this population. We will assess the effectiveness and cost-effectiveness of standard PE, iPE and PBT in patients with CA-PTSD.</AbstractText><AbstractText Label="METHODS/DESIGN">Multi-center randomized controlled trial. Treatment conditions are: prolonged exposure (PE; maximum of 16 sessions in 16 weeks); intensified PE (iPE; maximum of 12 sessions in four weeks and two booster sessions); phase-based treatment (PBT; maximum of eight sessions skills training followed by eight sessions PE in 16 weeks).</AbstractText><AbstractText Label="PRIMARY OUTCOME">Clinician-rated PTSD symptom severity.</AbstractText><AbstractText Label="SECONDARY OUTCOMES">loss of PTSD diagnosis, self-reported PTSD symptom severity, comorbid symptom severity and quality of life. Moreover, we will examine cost-effectiveness and moderators and mediators of treatment outcome.</AbstractText><AbstractText Label="TARGET POPULATION">adults with CA-PTSD (N = 150). Assessments in weeks 0, 4, 8, 16, 26 and 52.</AbstractText><AbstractText Label="DISCUSSION">Given that no consensus yet exists about the treatment guidelines for patients with CA-PTSD, the present study may have important implications for the treatment of CA-PTSD.</AbstractText><AbstractText Label="TRAIL REGISTRATION">Registered at C.C.M.O. on Sept 7, 2016 (NL57984.058.16); retrospectively registered at June 21, 2017 at clinicaltrials.gov identifier: NCT03194113 .</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Oprel</LastName><ForeName>D A C</ForeName><Initials>DAC</Initials><AffiliationInfo><Affiliation>Leiden University, Institute of Psychology, Wassenaarsweg 22, 3332, AK, Leiden, The Netherlands.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Parnassiagroep, PsyQ, Lijnbaan 4, 2512, VA, The Hague, The Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hoeboer</LastName><ForeName>C M</ForeName><Initials>CM</Initials><AffiliationInfo><Affiliation>Leiden University, Institute of Psychology, Wassenaarsweg 22, 3332, AK, Leiden, The Netherlands.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Parnassiagroep, PsyQ, Lijnbaan 4, 2512, VA, The Hague, The Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Schoorl</LastName><ForeName>M</ForeName><Initials>M</Initials><Identifier Source="ORCID">0000-0002-6468-3934</Identifier><AffiliationInfo><Affiliation>Leiden University, Institute of Psychology, Wassenaarsweg 22, 3332, AK, Leiden, The Netherlands. m.schoorl@fsw.leidenuniv.nl.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Parnassiagroep, PsyQ, Lijnbaan 4, 2512, VA, The Hague, The Netherlands. m.schoorl@fsw.leidenuniv.nl.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>De Kleine</LastName><ForeName>R A</ForeName><Initials>RA</Initials><AffiliationInfo><Affiliation>Leiden University, Institute of Psychology, Wassenaarsweg 22, 3332, AK, Leiden, The Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Wigard</LastName><ForeName>I G</ForeName><Initials>IG</Initials><AffiliationInfo><Affiliation>Parnassiagroep, PsyQ, Lijnbaan 4, 2512, VA, The Hague, The Netherlands.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Clinical Psychology, University of Amsterdam, Overschiestraat 61, 1062, XD, Amsterdam, The Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Cloitre</LastName><ForeName>M</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Department of Psychiatry and Behavioral Sciences, Stanford University, Palo Alto, CA, USA.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>National Center for PTSD Dissemination and Training Division, Palo Alto Veterans Affairs Palo Alto Health Care System, 795 Willow Road, Menlo Park, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Van Minnen</LastName><ForeName>A</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>PSYTREC, Prof. dr. Bronkhorststraat 2, 3723, MB, Bilthoven, The Netherlands.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Radboud University, Behavioural Science Institute, Nijmegen, The Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Van der Does</LastName><ForeName>W</ForeName><Initials>W</Initials><AffiliationInfo><Affiliation>Leiden University, Institute of Psychology, Wassenaarsweg 22, 3332, AK, Leiden, The Netherlands.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Parnassiagroep, PsyQ, Lijnbaan 4, 2512, VA, The Hague, The Netherlands.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Psychiatry, Leiden University Medical Center, Leiden, The Netherlands.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><DataBankList 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