Mayesero. 2012 Apr 27; 13 (1): 43.
Jager S, Muller KW, Ruckes C, Wittig T, Batra A, Musalek M, Mann K, Wolfling K, Beutel ME.
ZOKHUDZA
MALANGIZO:
Zaka zingapo zapitazi, kugwiritsa ntchito intaneti kwambiri komanso masewera a makompyuta zawonjezeka kwambiri. Kulimba, kusintha kwa malingaliro, kulolerana, zizindikiro zakuchotsera, kusamvana, kufotokozedwanso kwafotokozedwa ngati njira yodziwira munthu omwe ali ndi vuto la kugwiritsa ntchito intaneti kapena kuzolowera kompyuta (CA) mdera la asayansi.. Ngakhale kuti anthu ambiri akufuna thandizo, palibe mankhwala enieni omwe angakhazikitsidwe bwino.
Njira / kapangidwe:
Chiyeso chachipatalachi chikufuna kudziwa zomwe zimayambitsa matenda osakhalitsa a IA / CA (STICA). Chithandizo chazachilengedwe chimaphatikiza kuchitapo kanthu kwamunthu payekha ndi gulu ndi kutalika kwa miyezi ya 4. Odwala adzapatsidwa mwachisawawa chithandizo cha STICA kapena gulu loyang'anira mndandanda. Miyeso yodalirika komanso yovomerezeka ya IA / CA komanso zizindikiro za malingaliro a co-morbid (mwachitsanzo, nkhawa yamagulu, kukhumudwa) idzayesedwa isanayambike, pakati, kumapeto, ndi miyezi ya 6 mutamaliza chithandizo.
ZOKAMBIRANA:
Chithandizo cha IA / CA chitha kugwiranso ntchito ndipo ndichofunikira kwambiri. Popeza ili ndi loyesa koyamba kuti mupeze vuto la mtundu wina, gulu la odikirira mndandanda lithandizidwa. Zabwino ndi zovuta zakapangidwe adakambirana.
Kulembetsa Kwambiri ClinicalTrials (NCT01434589).
Mawu osokoneza bongo osokoneza bongo, kusuta kwa masewera a pakompyuta, STICA, kulowererapo, kugwiritsa ntchito machitidwe ozindikira
Background
Intaneti yakhala ikupezeka kwa anthu ambiri (mwachitsanzo, mitengo yafulati, WLAN, kapena makompyuta onyamula). Pampulu yoyimira ya Germany (n = 2475) ku 2009 kuchuluka kwa ogwiritsa ntchito pa intaneti kwa azimayi kunali pafupifupi 51% komanso kwa amuna pafupifupi 60%. Ntchito zomwe amagwiritsidwa ntchito pa intaneti nthawi zambiri zinali maimelo (93%), chidziwitso ndi kafukufuku (92%), kugula (76%), ndi kucheza (62%) [1]. Mu 2004 pafupifupi 68% ya akulu aku America amagwiritsa ntchito intaneti pafupipafupi ndipo 4% mpaka 14% adawonetsa chizindikiro chimodzi kapena zingapo zogwiritsa ntchito zovuta pazomwe zili ndi vuto la intaneti (IA) pafupifupi 1% [2], yomwe imagwirizana ndi Mjeremani weniweni phunzirani [3].
Kukhazikika kwa chizolowezi chowonekera kumanenedwa kumapeto kwa 20 kapena magulu azaka zama 30s [2]. M'maphunziro a mliri, kuchuluka kwa anthu ogwiritsa ntchito intaneti komanso ma X masewera a pakompyuta pakati pa 1.5% mpaka 3.0% ku Germany [3,4] ndi achinyamata aku Austria [5],.
Malinga ndi block [6], ma subtypes atatu a IA / masewera osokoneza bongo apakompyuta (CA) (masewera olimbitsa thupi mopitirira muyeso, chisangalalo chogonana, ndi maimelo / mameseji olembera) ali ndi magawo anayi ofanana: nthawi kapena kusazindikira zoyendetsa zoyambira); (b) Kuchotsa (mwachitsanzo, kusamvana, kupsa mtima, kukwiya, ndi / kapena kukhumudwa pakakhala kuti pakompyuta patatsekedwa; (c) kulolerana (kuchuluka kogwiritsa ntchito kapena kusanja kwa zida zamakompyuta); / kuchita, kutopa, kudzipatula pagulu, kapena kusamvana) Kuzindikira, kusinthasintha kwa malingaliro, kulolerana, zizindikiro zochotsa, kusamvana, kubwereranso ndi njira zina zowonetsera matenda a IA ndi CA [7]. Wodabwitsayo amatha kukopeka ndikuchita zambiri ndipo moyo umakhudzidwa ndi momwe amagwiritsidwira ntchito (mwachitsanzo masewera apakompyuta), kumafuna nthawi yambiri kuti athe kuwongolera zochitika zake. Kafukufuku wa Empirical [4,8,9] awonetsa kuti chizindikiro cha IA / CA [10,11] chikufanana ndi zomwe zimapangitsa kuti pakhale vuto la zinthu. Zotsatira zamaphunziro a neurobiological zazindikira njira zama neurophosological mu IA / CA ofanana ndi kugwiritsa ntchito mankhwala osokoneza bongo (mowa [12] ndi mankhwala osokoneza bongo a cannabis [13]).
Odwala omwe ali ndi CA ndi IA akhala akupempha thandizo mu uphungu wokhudzana ndi mankhwala ozunguza bongo [14], chifukwa cha zotsatira zoipa zoipa zamaganizo (zamakhalidwe, ntchito / maphunziro, thanzi) zomwe zalembedwa pamodzi ndi matenda a m'maganizo [15-19]. IA imagwirizanitsidwa kwambiri ndi kupsinjika kwakukulu [18,20], zizindikiro za kudzipatula kwa chikhalidwe kapena zikhalidwe (mwachitsanzo ADHD [18,21,22]), kapena impulsivity [23]. Mu chipatala cha Grüsser-Sinopoli Outpatient chaukadaulo wamakhalidwe, kuyambira 2008 mpaka 2010, odwala 326 onse adayesedwa ku IA / CA poyesedwa ndi mayeso azachipatala. Mwa iwo, odwala 192 adasankhidwa kuti IA / CA. Adali amuna komanso amuna (97%) kuyambira zaka za 18 mpaka 30. Adawonetsa umboni wamphamvu wakusokonekera kwa chikhalidwe cha anthu komanso kukhumudwa komanso kuchepa kwa magwiridwe ntchito kusukulu ndi kuntchito.
Ngakhale kufunikira kochulukirapo monga vuto lalikulu azaumoyo pakati pa achinyamata ndi achinyamata pakadali pano, pakalibe kusowa kwa njira zochitira umboni za IA / CA. Umboni woyambirira udangopezeka m'mayesero otseguka kwa anthu omwe si a ku Europe ndi ku Asia [24,25]. Chifukwa chake, pulogalamu yapadera yothandizira kwakanthawi kwa IA / CA, yozikidwa pa chidziwitso cha machitidwe ogwirira ntchito (STICA) idapangidwa. Kuyesa koyambirira kwa chithandizo cha mankhwala ovomerezeka a STICA kunachitidwa poyeserera poyera kuchipatala cha Grüsser-Sinopoli kunja kwa odwala omwe ali ndi chiwerewere cha 33. Makumi makumi awiri ndi anayi mwa zitsanzozi adatsiriza STICA pafupipafupi, odwala asanu ndi anayi adathetsa chithandizo msanga ndipo adawonedwa ngati otsika (27%). Kutengera zitsanzo zonse za odwala a 33 (cholinga chothana ndi kusanthula) njira zoyankhira chithandizo (zoyesera mwanzeru) zimafikiridwa ndi 67% yomwe ikufanana ndi kukula kwakukulu kwa 1.27 [Wölfling K, Müller KW, Beutel ME: Zotsatira za zolemba zamakhalidwe ogwiriridwa pamankhwala omwe ali pa intaneti komanso pakompyuta, osasindikizidwa]. Phunziroli liwunika luso la STICA yolemba. Kuphatikiza apo, kulimba kwa mayankho a mankhwalawa mwa odwalawa komanso momwe zimayendera pazotsatira zamisala yokhudzana ndi matenda amisala (mwachitsanzo nkhawa zamagulu ndi nkhawa) zidzatsimikizika. Pakadali pano STICA ndiyo pulogalamu yokhazikika yochiritsira odwala IA / CA ku Germany [26] komanso malingaliro apadziko lonse komanso mayesero azachipatala sanali okhutiritsa mwanjira [27].
Njira / Kulinganiza
Malo ophunzirira
Kafukufuku wambiriyu amayanjanitsidwa ndi chipatala cha kunja kwa odwala chifukwa chazomwe zimayambitsa Chipatala cha Psychosomatic Medicine ndi Psychotherapy a University Medical Center Mainz. Malo atatu atenga nawo mbali, a Anton-Proksch-Institute, Austria, Section Addiction Medicine and Addiction Research of the University Hospital Tübingen, ndi Chowonjezera Medicine cha Central Institute of Mental Health ku Mannheim. Ofufuza m'malo onse ndi akatswiri azachipatala (akatswiri amisala kapena akatswiri azamankhwala) ndi akatswiri othandizira anthu omwe ali ndi vuto losokoneza bongo.
ophunzira
Odwala adzaphatikizidwa, ngati njira zisanu ndi zitatu zotsatirazi zikukwaniritsidwa: (1) IA / CA malinga ndi AICA (kuwunika kwa Internet ndi Computer masewera osokoneza) malingaliro a akatswiri osachepera miyezi ya 6 ndi (2) muyezo score 7 AICA yodzilemba IA / CA. (3) Odwala omwe ali ndi vuto la co-morbid adzaphatikizidwa, bola ngati IA / CA ndiye matenda oyamba. Phunziroli lidzangophatikizapo amuna a (4) mu (5) zaka zapakati pa 17 ndi 45. (6) Ngati odwala pakadali pano ali pa mankhwalawa a psychotropic, palibe kusintha kwamankhwala ndi mankhwalawa m'miyezi yapitayi ya 2 komanso panthawi ya STICA chithandizo chololedwa. (7) Ngati pakadali pano onse ali ndi mankhwala onse a psychotropic, wodwala ayenera kuti adachotsedwa masabata a 4. (8) Mu STICA palibe psychotherapy yokhayo yomwe imaloledwa ndipo psychotherapy yam'mbuyomu iyenera kuti idamalizidwa milungu ingapo ya 4.
Odwala omwe ali ndi gawo <40 mu Global Assessment of Functioning (GAF [28]) kapena kukhumudwa kwakukulu (Beck Depression Inventory; BDI-II [29] ≥ 29) satulutsidwa. Zowonjezera zakulekerera ndi zakumwa zoledzeretsa kapena zakumwa mankhwala osokoneza bongo, malire, malire, kusagwirizana, schizoid, ndi kusokonezeka kwa umunthu wa schizotypal, matenda a schizophrenia, schizoaffective, bipolar, kapena matenda amisala komanso matenda osakhazikika apano.
Pazaka zambiri za miyezi ya 36 timakonzekera kuphatikiza odwala 192 mu phunziroli. Odwala adzapatsidwa mwachisawawa kuchitapo kanthu kapena kwa gulu la odikirira mndandanda (WLC). Asanachitike mwachisawawa, odwala onse a 18 amayenera kuperekedwa pamlanduwo. Gulu lolowererapo liyamba kulandira mankhwala atangosintha mwachisawawa, pomwe gulu la WLC liyenera kudikirira kwa miyezi ingapo ya 4, kufikira atalandira chithandizo chomwecho.
Kupewera
STICA yolemba [26] yozikidwa pamakhalidwe ogwirira ntchito komanso kuphatikiza gulu ndi chithandizo cha munthu payekha. STICA imakhala ndi magawo a 23 psychotherapy nthawi yayitali yonse ya miyezi ya 4.
Magawo khumi ndi asanu ndi awiri mwa magawo makumi awiri ndi atatu adzakhala magawo a gulu la sabata (100 mphindi iliyonse) ndipo asanu ndi atatu akhale magawo amodzi mokha (50 min).
Gawo la 1 likuwonetsa magawo azamankhwala ndi njira zakale, pakati, komanso kuthetsa gawo.
Kutengera kumvetsetsa kwamakanidwe ndi zovuta za IA / CA (gawo loyambirira), odwala amaphunzitsidwa kuti azindikire zomwe zimayambitsa kugwiritsa ntchito intaneti mosavomerezeka. Pogwiritsa ntchito diaries, kuphunzira maluso, komanso kuphunzitsa maluso, odwala amaphunzira kuchepetsa ndikuwongolera kugwiritsa ntchito makompyuta ndi intaneti. Mu gawo lomaliza la mankhwalawa, zida zidzasinthidwa ku moyo watsiku ndi tsiku ndi njira zothandizira kupewa kubwezeretsanso zomwe takambirana.
Gulu 1. STICA Magawo azithandizo ndi njira - onani PDF
Kufufuza
Chithunzi 1 chikuwonetsa chojambulidwa cha nthawi zisanu zowunika. Ku T0a odwala amauzidwa za phunziroli ndikuwunikira kuti ayenerere. Odwala amadzaza AICA-S [30,31] Müller KW, Glaesmer H, Brähler E, Wölfling K, Beutel M; Zomwe anthu amakonda kugwiritsa ntchito pa intaneti. Zotsatira zakufufuza kochokera ku Germany. chosasindikizidwa komanso BDI-II [29]. Makhalidwe a AICA-S ali pakati pa 0 ndi 27, ndipo zambiri ≥ 7 zatchulidwa kuti kugwiritsa ntchito intaneti zovuta. Othandizira amawunika koyambira, kumene, ndi njira za IA / CA, mbiri ya chithandizo, zolimbikitsira zochiritsira, ndi GAF [28]. Mndandanda wa AICA udzavotera wovunda ndi wakhungu.
Chithunzi 1. Zolemba zakuyenda za phunziroli. Odwala a gulu loyang'anira mndandanda wodikirira (WLC) adzapatsidwa chithandizo cha STICA gulu lolowererapo litatha. Kuwunika kotsatila kudzachitidwa mosiyana ndi WLC
T0b yowunikira imachitidwa musanachitike mwachisawawa ndikukhazikitsa chithandizo. Njira za IA / CA zithandizidwanso ndikuwonetsa nokha malipoti, ngati kuchedwa chifukwa chogwiritsa ntchito gulu kupitirira masabata a 2. Othandizira amadzaza GAF [28] ndikusonkha zidziwitso zamankhwala, zithandizo zina, ndi mbiri yachipatala. Woyimira pawokha komanso wosaona adzayesa kusokonezeka kwa malingaliro ndi SCID-I / II [32] ndikuyendetsa AICAChecklist. Kuwona mankhwala osokoneza bongo kumagwiritsidwanso ntchito kuyesa kudziwa tanthauzo la kumwa mankhwalawa.
Kudzilemba pawokha kumaphatikizapo IA / CA (AICA-S [30-31]), kupsinjika (BDI-II [29]), chizolowezi chochita zinthu kwambiri (SCL-90-R [33]), nkhawa komanso mantha kwambiri (Health Patient Health)
Mafunso [34], somatization [34], global general [34], depersonalization (CDS-2 [35]), komanso mantha pagulu (LSAS [36]). Odwala nawonso amadzaza machitidwe a umunthu (NEO-FFI [37]), chidwi deficit disorder (WURS-k [38]), kudzichitira nokha zinthu (SWE [39,40]), chosalimbikitsa komanso chosalimbikitsa (PANAS [41]), ndi zokumana nazo zovuta zamagulu (ACE [42]). Pomaliza, amayankha mafunso okhudza kupanikizika kozindikira (PSS [43]) komanso zokhuza kukhutitsidwa kwa moyo wawo (FLZ [44]). Chidwi cha odwala chiziwunikidwa ndi d2 [45].
Pambuyo pa miyezi ya 2 yothandizira (T1) njira zotsatila zodwala zimayikidwanso (AICA, GAF, BDIII) ndikuwunikira mobwerezabwereza kwa mankhwala. Njira zoyambira zimatsatiridwa ndikuwunika kwa gulu la nyengo (GCQ [46]) ndi mgwirizano wa achire (HAQ [47]).
Atangomaliza kulowererapo (T2) odwala amadzaza mafunso ofanana ndi omwe adakhazikitsidwa ku T0b, kupatula njira zamtunduwu (NEO-FFI, WURS-k, ACE). Mgwirizano wamagulu ndi othandizira amawunikiranso. Kuwona mankhwala osokoneza bongo kumayikidwa ndipo ndikofunikira. Kwa odwala a gulu la WLC uku ndi kuwunika komaliza. Patangotha kafukufukuyo kulowererapo kwawo kuyayamba. Odwala a gululi lolowererapo amafunsidwa kuti ayese kukhazikika kwa zovuta zamankhwala 6 miyezi ingapo atathetsa chithandizo (T3). Pamenepo mafunso omwe amagwiritsidwa ntchito amafanana ndi T2.
Kusonkhanitsa deta
Phunziroli pali magawo awiri azidziwitso zamagetsi zamagetsi. ECRF yapangidwa kuti ofufuzawo alembe zomwe awerenga mu database yosungidwa, yosungidwa, ndikuyendetsedwa ndi IZKS Mainz. Imasungidwa ndi achinsinsi pa akaunti zonse za omwe amafufuza. Odwala amayankha mafunso omwe amadzipangira okha mwa kulemba ma fomu omwe amapangidwira ma iPAD. Wodwala aliyense amangolandira mafunso ake okha. Pambuyo pakupeza deta, eCRF ndi data ya iPAD idzasinthidwa kukhala database imodzi ya SAS yowunikira.
Zolinga ndi malingaliro
Zolinga kapena kafukufukuyu ndikuwonetsetsa kuti STICA ndiyothandiza, kuwunika kulimba kwa mayankho a odwala mwa iwo, komanso momwe zimayendera pazizindikiro zam'maganizo (mwachitsanzo, nkhawa komanso kukhumudwa).
Zotsatira
Mapeto oyambira kumapeto kwa ntchito amatanthauzidwa kuti kusintha kwa IA / CA kumavoteredwa ndi wodwalayo (zotsatira zoyambira: AICA-S [30, 31]). Pamapeto pa chithandizo chiphaso cha AICA-S <7 chikuwonetsa kukhululukidwa.
Kutsiriza kwachiwiri kumaphatikizapo kuchotsedwa kwa IA / CA muyezo wa akatswiri (AICA-C ≤ 13). Kuchita chidwi ndi intaneti kapena masewera apakompyuta azisanthula (maola ogwiritsidwa ntchito sabata limodzi). IA ndi CA zimagwirizanitsidwa ndi zotsatira zoyipa paumoyo, kulumikizana ndi anthu, kukhala ndi thanzi la m'maganizo (GAF [28], BDI-II [30], LSAS [36]), mulingo wakuchita kusukulu kapena pantchito, komanso kuchita bwino (SWE [ 39]). Pa kuyesa kwa chida chilichonse pamayeso kufananizidwa ndi kuyesa komwe kunapezedwa 4 ndi 6 miyezi ingapo itatha.
Kuwerengera kukula
Kuwerengera kukula kwazitsanzo kumakhazikitsidwa pamapeto oyambira (T2: kutha kwamankhwala) ndi kuyesa kwa chisquare popanda kukonza mosalekeza pamizere iwiri yofunika ya 0.05. Kuwerengerako kutengera zotsatira za odwala 33, omwe adatenga nawo gawo poyeserera. Odwala makumi awiri mphambu anai asintha malinga ndi AICA-S <7. Kusiyana kwa gulu lolamulira la 20% kumawerengedwa kuti ndiwothandiza kuchipatala. Ndi mphamvu ya 90%, odwala 184 athunthu amafunikira kuti azindikire kusiyana kumeneku. Poganizira kukula kwa gulu lamankhwala eyiti, maphunziro a 16 amayenera kusinthidwa nthawi yomweyo. Chifukwa chake, tifunika kuphatikiza odwala 192 pakuyesaku (n = Odwala 96 pagulu lirilonse). Kuwunika koyambirira kudzachitika pa anthu onse omwe ali ndi maphunziro osadziwika (omwe akufuna kuchitira (ITT) anthu). Ophunzira omwe asiya mankhwalawa adzawerengedwa kuti siopindulitsa kuchipatala. Zomwe tidakumana nazo kale pa omwe adakonda kugwiritsa ntchito intaneti zidawulula zakusiyira kwa 27% (kutaya asanu ndi anayi kuchokera kwa odwala 33).
Randomization
Odwala adzapatsidwa mwachisawawa gulu la STICA kapena gulu la WLC.
Mndandanda wamtunduwu udzapangidwa mwaubwino ndi Interdisciplinary Center for Clinical Trials (IZKS). Poganizira kukula kwa gulu lachipatala la odwala eyiti, odwala 16 amayenera kusinthidwa nthawi yomweyo. Chiwerengero cha makina osankhidwa mwadzidzidzi chidzakhala 1: 1 mkati mwanjira iliyonse. Pambuyo pakutsimikizira kuti wodwala amakwaniritsa njira zonse zakuphatikizira mosintha, fomu yofotokoza zaukadaulo yamagetsi (eCRF) ipereka msanga zofunikirazo ndi zotsatira zake. Odwala amauzidwa za zotsatira za chisankho ndi kusankhaku kumayambira posakhalitsa. IZKS ipitiliza kukulitsa kukhulupirika kwa chithandizo chamankhwala pochezera pafupipafupi.
Kusanthula kusanthula
Kusanthula koyambirira
Malo oyambira mwamphamvu amadziwika kuti ndi kusintha kwa AICA-S. Izi zikuwunikidwa pogwiritsa ntchito njira yoyeserera yolingana ndi olosera zamagulu (STICA chithandizo vs WLC), pre-chithandizo cha AICA-S, maphunziro, malo oyeserera, komanso zaka.
Mawu oyamba oti ayesedwe ndi awa:
H0: πSTICA = πWLC vs. H1: πSTICA ≠ πWLC
komwe πSTICA ndi πWLC ndizomwe zimayankhira kulandira chithandizo mu gulu la chithandizo cha STICA ndi gulu la WLC, motsatana. Kusanthula koyambirira kudzachitidwa pa anthu a ITT pamlingo wofunikira mbali ziwiri-α = 0.05. Gawo la mbali ziwiri zofunikira ndizofanana pa kusanthula konse. Kusanthula kokwanira kumachitidwa kuti mumve zambiri. Kuphatikiza apo, kuwunikiraku kubwerezedwa ndikulosera kwa gulu lachipatala. Kuchepetsa pakapita nthawi ya chithandizo kumanenedwa ngati zolephera zamankhwala.
Kusanthula kwachiwiri
Kuchotsedwa kwa IA / CA malinga ndi mindandanda ya AICA kuyesedwa pogwiritsa ntchito kusanthula kwa zinthu zomwe zikuwoneka ndi olosera omwewo monga kuwunika koyambirira. Kuchepetsa kwa zoyipa, GAF, kukhumudwa (BDI-II), ndi nkhawa zamagulu (LSAS) zifufuzidwa pogwiritsa ntchito ANCOVA ndi covariates.
Kusanthula kudzachitidwa pamlingo wokhazikika mbali ziwiri za α = 0.05. Ziwerengero zofotokozera zimagwiritsidwa ntchito kuwonetsa kusintha pakapita nthawi. Zochitika zazikuluzikulu ndi kusiya zimawonetseredwa pogwiritsa ntchito ziwerengero zofotokozera.
Zachitetezo
Magawo otetezedwa aphatikizira kuwunika komwe kungachitike kumene kwa matenda amisala (SCID-I [32]) ndi zochitika zonse zowopsa zomwe zimanenedwa pakapita miyezi ingapo ya 6 mutalandira chithandizo. Chifukwa chake pamalingaliro a psychotherapy malingaliro ofuna kudzipha kapena magwiridwe antchito apadziko lonse lapansi awonedwa.
Mavuto azachipatala
Malinga ndi GCP, chochitika chovuta (AE) chimafotokozeredwa motere: zochitika zilizonse zachipatala zodwala zomwe wodwala amatenga nawo mbali pachipatala. AAE itha kukhala chizindikiro chosasangalatsa komanso chosakonzekera (kuphatikiza mankhwalawa), chizindikiro, kapena matenda, ngakhale osakhudzana ndi kulowererapo. Chifukwa chakuti mayesowa amawunika chithandizo chamankhwala, ma AE okha okhudzana ndi malingaliro am'maganizo, omwe amafotokozedwa ngati vuto lililonse lomwe lafotokozedwa ndi International Classization of Diseases [48] F00-F99 ('Mental and Behavioral Disrupt') lidzalembedwanso.
Pa kafukufukuyu mikhalidwe yotsatirayi idafotokozedwa ngati AE: (1) zatsopano / zikhalidwe zamankhwala, (2) matenda atsopano, (3) matenda wamba ndi ngozi, (4) zikuipiraipira kwa zikhalidwe zamankhwala / matenda omwe analipo mayeso azachipatala asanayambe, ( 5) kubwereza matenda, kapena (6) kuchuluka kwa pafupipafupi kapena kuchuluka kwa matenda amisala.
Chochitika chovuta kwambiri (SAE) ndi AE chomwe: (1) chimabweretsa imfa, (2) ndi chiopsezo cha moyo, (3) chimafuna kuchipatala kwa odwala kapena kutalika kwa chipatala chomwe chilipo, (4) kumapangitsa kulumala kapena kulephera / kuthekera kwakukulu / kusatha , kapena (5) ndi vuto lobadwa nalo.
Mavuto onse azachipatala pa phunziroli adalembedwa mu eCRF.
Nkhani zamakhalidwe
Zotsatira zamankhwala ndi kuvomerezeka kozindikira zidavomerezedwa ndi Ethics Committee (EC) ya Federal State of Rhineland Palatinate (Germany), yomwe imayang'anira bungwe loyang'anira Mainz (Ref. No. 837.316.11 (7858)). Ma komiti Achikhalidwe amalo onse othandizana nawo apereka zolemba zina zofunika.
Njira zonse zofotokozedwa mu protocol ya mayesero azachipatala zimatsata malangizo a ICH-GCP ndi mfundo zamakhalidwe zomwe zafotokozedwa pakukonzanso kwa Declaration of Helsinki. Mlanduwo uzichitika malinga ndi zofunikira zalamulo zakwanuko.
Asanavomerezedwe kuchipatala, odwala amalandiridwa mwatsatanetsatane za mawonekedwe, kukula, ndi zotheka za mayeso azachipatala mwanjira yomveka kwa iwo. Otsatira ayenera kupereka chilolezo polemba. Wodwala aliyense alandila chikalata chovomerezeka chovomerezeka.
Mu mayeso azachipatala awa odwala onse, kuphatikiza ndi gulu la WLC alandila chithandizo chonse. Kwa odwala a WLC chithandizo chimayamba pakadutsa miyezi 4.
Bungwe loyimilira la Data Monitoring and Safety Board (DMSB) likhazikitsidwa phunziroli.
DMSB imayang'anira kuyeserera kwa mlanduwu ndipo ikupereka malingaliro oyambira, kusintha kapena kupitiliza kwa mlanduwo, ngati pakufunika kutero. DMSB ndi EC ziyenera kudziwitsidwa mwachangu za SAE zokhudzana ndi kuphunzira.
Kukambirana
Chiwerengero cha odwala omwe ali ndi IA / CA omwe akufuna thandizo la akatswiri akuchulukirachulukira. Mpaka pano palibe pulogalamu yeniyeni yolowererapo ndipo palibe chithandizo chofotokozedwera bwino chothandiza. Pazidziwitso zathu, STICA ndiyoyeso yoyamba kuchipatala yokhazikitsa njira yeniyeni ya chithandizo cha IA / CA.
Kuchita bwino kwa mankhwalawa kumayesedwa mosavomerezeka koyesedwa kwamitundu yambiri. Kugwiritsa ntchito gulu la WLC kumawoneka ngati kolondola chifukwa cha njira yothandizira chithandizo chamankhwala ndi kusowa kwa njira zofananira. Odwala ku WLC akutsimikiziridwa kuti azilandira chithandizo chokwanira pakatha nthawi yodikirira ya 4 miyezi itatha. Chifukwa chake, kutsata kwa zowongolera pamndandanda sikungatheke.
STICA iwonanso kusokonezeka kwamalingaliro m'maganizo ndi zotsatirapo zoyipa zazitali (mwachitsanzo, kusiya anthu kapena kulephera kusukulu / maphunziro) chifukwa cha intaneti kapena kugwiritsa ntchito masewera a pakompyuta. Cholinga cha STICA ndikukhazikitsanso odwala kuti akhale moyo wabwinobwino, kuphatikiza kugwiritsa ntchito makompyuta ndi intaneti, kucheza pagulu, komanso kugwira ntchito.
Zotsatira za phunziroli ndizofunika kwambiri chifukwa cha kufunikira kwa njira komanso kufunika kwa mutuwo. Kafukufukuyu akuwonetsa kuwongolera kwakanthawi kochepa kochizira kwa IA / CA. Kwa chisamaliro chodwala ndikofunikira kukhazikitsa chithandizo chokwanira cha IA / CA munthawi yamankhwala.
Mkhalidwe woyeserera
Wodwala woyamba adalembetsa nawo kuphunzira ku STICA pa February 1, 2012. Njira zotsatirira odwala omwe adaphatikizidwa komaliza amayembekezeka kutha mu June 2014.
achidule
ACE, zovuta zokumana ndiubwana AE, Chochitika Chosiyana; ADHD, Atticitic deficit hyperacaction chisokonezo; AICA-S, Kuyesa kwa intaneti komanso masewera osokoneza bongo pakompyuta, lipoti la inu; AICA-Mndandanda, kuwunika kwa intaneti ndi masewera a pakompyuta, kuwunika kwa akatswiri; BDI-II, Beck Depression Inventory; CA, Kusuta kwa masewera a pakompyuta; CDS-2, lonse la Cambridge depersonalization; DFG, Deutsche Forschungsgemeinschaft; DMSB, Kuwunika kwa Data ndi Board Board; d2, Kuyesa kwa chidwi; EC, Komiti ya Makhalidwe; eCRF, Fomu Yaposaka Yamagetsi; FLZ, Mafunso pa kukhutitsidwa kwa moyo; GAF, Kuyesa Kwadziko lonse Kogwira Ntchito; GCP, Njira Zabwino Zachipatala; HAQ, Mafunso othandizira othandizira; ICH, Msonkhano wapadziko lonse wokhudzana ndi Kufunika Kwaukadaulo Kulembetsa kwa Mankhwala Ogwiritsira Ntchito Mankhwala Anthu; IA, mankhwala osokoneza bongo pa intaneti; ITT, Cholinga chochitira; IZKS, Center yapakati pa mayesero azachipatala; LSAS, Liebowitz nkhawa za chikhalidwe cha anthu; NEO-FFI, NEO Zinthu zisanu zofunika; PANAS, Dongosolo labwino komanso loipa; PHQ, funso la odwala odwala; PSS, Anazindikira nkhawa; SAE, Chochitika Chovuta; SCID, I / II Zokambirana zakuchipatala za DSM IV; SCL-90-R, Mndandanda wa Zizindikiro 90 wokonzanso; STICA, Chithandizo Chaposachedwa Pakanthawi paintaneti; SWE, Kuyesa kwachiyembekezo cha kudzikwaniritsa; WLC, Kudikira mndandanda; WURSk, Wender Uta rating mulingo.
Zosangalatsa zovuta
Olemba amanena kuti alibe zopikisana.
Zopereka za olemba
SJ adachita zoyambirira zolembedwa pamanja ndipo ndi munthu wofunsa mafunso pazakuzindikira, kapangidwe, ndi kayendedwe. SJ, MEB, ndi KW adapanga zolemba zomaliza ndipo adazikonzanso bwino kuti zidziwike. KW ndi MEB adapanga chithandizochi, chomwe chiziwunika ndi phunziroli. Malangizowo adakonzedwa koyamba ndi KW, KWM, MEB, ndi CR. Pa thandizo MEB ndi KW amagwira ntchito ngati wofufuza mfundo komanso mfundo. MEB ndiye amachititsa izi. KWM, CR, TW, KW, ndi MEB zidathandizira mokulira pakupanga kuphunzira ndi mapangidwe omaliza a kafukufukuyu. AB, MM, ndi KM ali ndi udindo wozindikira STICA m'malo osiyanasiyana ndikuthandizira kukonza kapangidwe kake. Olemba onse adawerenga ndikuvomereza zolemba zomaliza.
Zothokoza
Phunziroli limathandizidwa ndi Deutsche Forschungsgemeinschaft (DFG) BE2248 / 10-1 ndi Germany Federal Ministry of Education and Research (BMBF) mothandizidwa ndi IZKS Mainz, yomwe imakhazikitsidwa ndi BMBF (FKZ 01KN1103).
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