Mind–body therapy via videoconferencing in patients with neurofibromatosis: An RCT

OBJECTIVE:To test, within a single-blind randomized controlled trial, the feasibility, acceptability, efficacy, and durability of a mind–body program (the Relaxation Response Resiliency Program for neurofibromatosis [3RP-NF]) vs an attention placebo control (Health Enhancement Program for NF [HEP-NF...

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Veröffentlicht in:Neurology 2016-08, Vol.87 (8), p.806-814
Hauptverfasser: Vranceanu, Ana-Maria, Riklin, Eric, Merker, Vanessa L, Macklin, Eric A, Park, Elyse R, Plotkin, Scott R
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container_end_page 814
container_issue 8
container_start_page 806
container_title Neurology
container_volume 87
creator Vranceanu, Ana-Maria
Riklin, Eric
Merker, Vanessa L
Macklin, Eric A
Park, Elyse R
Plotkin, Scott R
description OBJECTIVE:To test, within a single-blind randomized controlled trial, the feasibility, acceptability, efficacy, and durability of a mind–body program (the Relaxation Response Resiliency Program for neurofibromatosis [3RP-NF]) vs an attention placebo control (Health Enhancement Program for NF [HEP-NF]), both delivered via group videoconferencing. METHODS:Sixty-three patients completed baseline assessments and were randomized. Primary outcomes were physical health and psychological quality of life (QoL), measured by the WHOQOL-BREF (World Health Organization QoL abbreviated instrument). Secondary outcomes were social relations and environment QoL, depression, anxiety, pain intensity, and pain interference. RESULTS:Sixty-three participants completed the intervention (100%) and 52 the 6-month follow-up (82.5%). Acceptability was 4.1 (5-point scale). Patients in the 3RP-NF showed greater improvement in physical health QoL (7.69; 95% confidence interval [CI]0.29–15.10; p = 0.040), psychological QoL (5.57; 95% CI0.17–11.34; p = 0.056), social relations QoL (10.95; 95% CI1.57–20.31; p = 0.021), environment QoL (8.02; 95% CI2.57–13.48; p = 0.005), and anxiety (−2.32; 95% CI−3.96 to 0.69; p = 0.006) compared to those in HEP-NF, and gains were maintained at follow-up. Patients in the 3RP-NF did not improve more than those in HEP-NF on depression, with both groups showing improvement. Patients in the 3RP-NF with baseline pain ≥5 of 10 showed improvement in pain intensity from baseline to posttest (1.30; 95% CI−2.26 to −0.34; p = 0.009) with effects maintained at follow-up; this improvement was not greater than that in HEP-NF. There were more treatment responders in the 3RP-NF group (p < 0.05). CONCLUSIONS:The 3RP-NF delivered via videoconferencing was highly feasible and accepted by patients, and resulted in sustained improvement in QoL. CLASSIFICATION OF EVIDENCE:This study provides Class II evidence that for patients with NF, a mind–body program is superior to an attention placebo control in improving QoL.
doi_str_mv 10.1212/WNL.0000000000003005
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METHODS:Sixty-three patients completed baseline assessments and were randomized. Primary outcomes were physical health and psychological quality of life (QoL), measured by the WHOQOL-BREF (World Health Organization QoL abbreviated instrument). Secondary outcomes were social relations and environment QoL, depression, anxiety, pain intensity, and pain interference. RESULTS:Sixty-three participants completed the intervention (100%) and 52 the 6-month follow-up (82.5%). Acceptability was 4.1 (5-point scale). Patients in the 3RP-NF showed greater improvement in physical health QoL (7.69; 95% confidence interval [CI]0.29–15.10; p = 0.040), psychological QoL (5.57; 95% CI0.17–11.34; p = 0.056), social relations QoL (10.95; 95% CI1.57–20.31; p = 0.021), environment QoL (8.02; 95% CI2.57–13.48; p = 0.005), and anxiety (−2.32; 95% CI−3.96 to 0.69; p = 0.006) compared to those in HEP-NF, and gains were maintained at follow-up. Patients in the 3RP-NF did not improve more than those in HEP-NF on depression, with both groups showing improvement. Patients in the 3RP-NF with baseline pain ≥5 of 10 showed improvement in pain intensity from baseline to posttest (1.30; 95% CI−2.26 to −0.34; p = 0.009) with effects maintained at follow-up; this improvement was not greater than that in HEP-NF. There were more treatment responders in the 3RP-NF group (p &lt; 0.05). CONCLUSIONS:The 3RP-NF delivered via videoconferencing was highly feasible and accepted by patients, and resulted in sustained improvement in QoL. CLASSIFICATION OF EVIDENCE:This study provides Class II evidence that for patients with NF, a mind–body program is superior to an attention placebo control in improving QoL.</description><identifier>ISSN: 0028-3878</identifier><identifier>EISSN: 1526-632X</identifier><identifier>DOI: 10.1212/WNL.0000000000003005</identifier><identifier>PMID: 27449066</identifier><language>eng</language><publisher>United States: American Academy of Neurology</publisher><subject>Adult ; Anxiety - etiology ; Anxiety - therapy ; Depression - etiology ; Depression - therapy ; Feasibility Studies ; Female ; Follow-Up Studies ; Humans ; Male ; Middle Aged ; Mind-Body Therapies - methods ; Neurofibromatoses - complications ; Neurofibromatoses - therapy ; Outcome Assessment (Health Care) ; Patient Acceptance of Health Care ; Psychotherapy, Group - methods ; Quality of Life ; Single-Blind Method ; Telemedicine - methods ; Videoconferencing</subject><ispartof>Neurology, 2016-08, Vol.87 (8), p.806-814</ispartof><rights>2016 American Academy of Neurology</rights><rights>2016 American Academy of Neurology.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>315,781,785,27928,27929</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27449066$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Vranceanu, Ana-Maria</creatorcontrib><creatorcontrib>Riklin, Eric</creatorcontrib><creatorcontrib>Merker, Vanessa L</creatorcontrib><creatorcontrib>Macklin, Eric A</creatorcontrib><creatorcontrib>Park, Elyse R</creatorcontrib><creatorcontrib>Plotkin, Scott R</creatorcontrib><title>Mind–body therapy via videoconferencing in patients with neurofibromatosis: An RCT</title><title>Neurology</title><addtitle>Neurology</addtitle><description>OBJECTIVE:To test, within a single-blind randomized controlled trial, the feasibility, acceptability, efficacy, and durability of a mind–body program (the Relaxation Response Resiliency Program for neurofibromatosis [3RP-NF]) vs an attention placebo control (Health Enhancement Program for NF [HEP-NF]), both delivered via group videoconferencing. METHODS:Sixty-three patients completed baseline assessments and were randomized. Primary outcomes were physical health and psychological quality of life (QoL), measured by the WHOQOL-BREF (World Health Organization QoL abbreviated instrument). Secondary outcomes were social relations and environment QoL, depression, anxiety, pain intensity, and pain interference. RESULTS:Sixty-three participants completed the intervention (100%) and 52 the 6-month follow-up (82.5%). Acceptability was 4.1 (5-point scale). Patients in the 3RP-NF showed greater improvement in physical health QoL (7.69; 95% confidence interval [CI]0.29–15.10; p = 0.040), psychological QoL (5.57; 95% CI0.17–11.34; p = 0.056), social relations QoL (10.95; 95% CI1.57–20.31; p = 0.021), environment QoL (8.02; 95% CI2.57–13.48; p = 0.005), and anxiety (−2.32; 95% CI−3.96 to 0.69; p = 0.006) compared to those in HEP-NF, and gains were maintained at follow-up. Patients in the 3RP-NF did not improve more than those in HEP-NF on depression, with both groups showing improvement. Patients in the 3RP-NF with baseline pain ≥5 of 10 showed improvement in pain intensity from baseline to posttest (1.30; 95% CI−2.26 to −0.34; p = 0.009) with effects maintained at follow-up; this improvement was not greater than that in HEP-NF. There were more treatment responders in the 3RP-NF group (p &lt; 0.05). CONCLUSIONS:The 3RP-NF delivered via videoconferencing was highly feasible and accepted by patients, and resulted in sustained improvement in QoL. CLASSIFICATION OF EVIDENCE:This study provides Class II evidence that for patients with NF, a mind–body program is superior to an attention placebo control in improving QoL.</description><subject>Adult</subject><subject>Anxiety - etiology</subject><subject>Anxiety - therapy</subject><subject>Depression - etiology</subject><subject>Depression - therapy</subject><subject>Feasibility Studies</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Humans</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Mind-Body Therapies - methods</subject><subject>Neurofibromatoses - complications</subject><subject>Neurofibromatoses - therapy</subject><subject>Outcome Assessment (Health Care)</subject><subject>Patient Acceptance of Health Care</subject><subject>Psychotherapy, Group - methods</subject><subject>Quality of Life</subject><subject>Single-Blind Method</subject><subject>Telemedicine - methods</subject><subject>Videoconferencing</subject><issn>0028-3878</issn><issn>1526-632X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkVFrFDEQx4NY7LX6DUT20ZetmSSbZH0rh9bCWaFc0beQvZt4sXvJmuz2uDe_g9-wn8SUVig-SAeGYWZ-MwzzJ-Q10BNgwN59vVic0EfGKW2ekRk0TNaSs2_PyYxSpmuulT4kRzn_oLQ0VfuCHDIlREulnJHlZx_Wt79-d3G9r8YNJjvsqxtvi68xrmJwmDCsfPhe-VANdvQYxlzt_LipAk4pOt-luLVjzD6_r05DdTlfviQHzvYZXz3EY3L18cNy_qlefDk7n58u6oFJ3dTYWZBWScUQOmwb13DKwTIOGlophMOVkAXUQjlouaVCKefQlVzKVrb8mLy93zuk-HPCPJqtzyvsexswTtmAVkoD18CegAJvKWeqKeibB3Tqtrg2Q_Jbm_bm79MKoO-BXexHTPm6n3aYzAZtP24MUHOnjyn6mH_1KaPiP6N3mAQQNaMgqWac1qVSrv8DiFaPmw</recordid><startdate>20160823</startdate><enddate>20160823</enddate><creator>Vranceanu, Ana-Maria</creator><creator>Riklin, Eric</creator><creator>Merker, Vanessa L</creator><creator>Macklin, Eric A</creator><creator>Park, Elyse R</creator><creator>Plotkin, Scott R</creator><general>American Academy of Neurology</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7X8</scope><scope>7TK</scope></search><sort><creationdate>20160823</creationdate><title>Mind–body therapy via videoconferencing in patients with neurofibromatosis: An RCT</title><author>Vranceanu, Ana-Maria ; Riklin, Eric ; Merker, Vanessa L ; Macklin, Eric A ; Park, Elyse R ; Plotkin, Scott R</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-p2685-eba16a7672e1be95f53031a231819644fec46685847f193a0477ffef847669693</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Adult</topic><topic>Anxiety - etiology</topic><topic>Anxiety - therapy</topic><topic>Depression - etiology</topic><topic>Depression - therapy</topic><topic>Feasibility Studies</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Humans</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Mind-Body Therapies - methods</topic><topic>Neurofibromatoses - complications</topic><topic>Neurofibromatoses - therapy</topic><topic>Outcome Assessment (Health Care)</topic><topic>Patient Acceptance of Health Care</topic><topic>Psychotherapy, Group - methods</topic><topic>Quality of Life</topic><topic>Single-Blind Method</topic><topic>Telemedicine - methods</topic><topic>Videoconferencing</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Vranceanu, Ana-Maria</creatorcontrib><creatorcontrib>Riklin, Eric</creatorcontrib><creatorcontrib>Merker, Vanessa L</creatorcontrib><creatorcontrib>Macklin, Eric A</creatorcontrib><creatorcontrib>Park, Elyse R</creatorcontrib><creatorcontrib>Plotkin, Scott R</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>MEDLINE - Academic</collection><collection>Neurosciences Abstracts</collection><jtitle>Neurology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Vranceanu, Ana-Maria</au><au>Riklin, Eric</au><au>Merker, Vanessa L</au><au>Macklin, Eric A</au><au>Park, Elyse R</au><au>Plotkin, Scott R</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Mind–body therapy via videoconferencing in patients with neurofibromatosis: An RCT</atitle><jtitle>Neurology</jtitle><addtitle>Neurology</addtitle><date>2016-08-23</date><risdate>2016</risdate><volume>87</volume><issue>8</issue><spage>806</spage><epage>814</epage><pages>806-814</pages><issn>0028-3878</issn><eissn>1526-632X</eissn><abstract>OBJECTIVE:To test, within a single-blind randomized controlled trial, the feasibility, acceptability, efficacy, and durability of a mind–body program (the Relaxation Response Resiliency Program for neurofibromatosis [3RP-NF]) vs an attention placebo control (Health Enhancement Program for NF [HEP-NF]), both delivered via group videoconferencing. METHODS:Sixty-three patients completed baseline assessments and were randomized. Primary outcomes were physical health and psychological quality of life (QoL), measured by the WHOQOL-BREF (World Health Organization QoL abbreviated instrument). Secondary outcomes were social relations and environment QoL, depression, anxiety, pain intensity, and pain interference. RESULTS:Sixty-three participants completed the intervention (100%) and 52 the 6-month follow-up (82.5%). Acceptability was 4.1 (5-point scale). Patients in the 3RP-NF showed greater improvement in physical health QoL (7.69; 95% confidence interval [CI]0.29–15.10; p = 0.040), psychological QoL (5.57; 95% CI0.17–11.34; p = 0.056), social relations QoL (10.95; 95% CI1.57–20.31; p = 0.021), environment QoL (8.02; 95% CI2.57–13.48; p = 0.005), and anxiety (−2.32; 95% CI−3.96 to 0.69; p = 0.006) compared to those in HEP-NF, and gains were maintained at follow-up. Patients in the 3RP-NF did not improve more than those in HEP-NF on depression, with both groups showing improvement. Patients in the 3RP-NF with baseline pain ≥5 of 10 showed improvement in pain intensity from baseline to posttest (1.30; 95% CI−2.26 to −0.34; p = 0.009) with effects maintained at follow-up; this improvement was not greater than that in HEP-NF. There were more treatment responders in the 3RP-NF group (p &lt; 0.05). CONCLUSIONS:The 3RP-NF delivered via videoconferencing was highly feasible and accepted by patients, and resulted in sustained improvement in QoL. CLASSIFICATION OF EVIDENCE:This study provides Class II evidence that for patients with NF, a mind–body program is superior to an attention placebo control in improving QoL.</abstract><cop>United States</cop><pub>American Academy of Neurology</pub><pmid>27449066</pmid><doi>10.1212/WNL.0000000000003005</doi><tpages>9</tpages></addata></record>
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subjects Adult
Anxiety - etiology
Anxiety - therapy
Depression - etiology
Depression - therapy
Feasibility Studies
Female
Follow-Up Studies
Humans
Male
Middle Aged
Mind-Body Therapies - methods
Neurofibromatoses - complications
Neurofibromatoses - therapy
Outcome Assessment (Health Care)
Patient Acceptance of Health Care
Psychotherapy, Group - methods
Quality of Life
Single-Blind Method
Telemedicine - methods
Videoconferencing
title Mind–body therapy via videoconferencing in patients with neurofibromatosis: An RCT
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