이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Priming Attachment Security Within an IAPT Setting

2019년 7월 13일 업데이트: Charlotte Heathcote, University of Sheffield

Priming Attachment Security Within an IAPT Setting: A Feasibility and Pilot Study

There is growing evidence that priming attachment security is associated with improved attitudes towards therapy, increased engagement and decreased levels of depression and anxiety. Within the Improving Access to Psychological Therapies (IAPT) programme a consistent problem has been identified of high dropout rates at step 2 services (i.e. where mild to moderate anxious and depressed patients receive guided self-help interventions). The current study incorporates a feasibility and pilot design. The feasibility element will explore issues related to study design to determine suitability for conducting a future randomised control trial (RCT). The pilot study will look at the processes outlined in the protocol to determine whether the study components all work together. Moreover, it will preliminarily aim to explore the effectiveness of the attachment security priming intervention on symptoms of depression and anxiety, as well as impaired functioning. Both elements of the study will determine whether any changes are needed to the study design or protocol, and whether a future RCT is suitable and necessary.

연구 개요

상태

알려지지 않은

정황

우울증

개입 / 치료

상세 설명

The study is being conducted in an IAPT primary care service in North Yorkshire. The study will be recruiting 50 participants experiencing mild to moderate depression who are deemed suitable for 'behavioural activation' low intensity guided self-help intervention. Following telephone screening for intervention, clinicians will ask clients if they wish to hear more about participating in a research study. If participants say yes, their contact details will be passed on to the researcher who will send them the study information sheet and consent form in the post. If the participant consents to taking part in the research, they will be randomised to receive either treatment as usual (low-intensity guided self-help utilising behavioural activation for depression) or treatment with security priming intervention (treatment as usual with an additional security priming task). They will have between 6-8 sessions as routinely delivered within the service and will be asked to complete measures of depression, anxiety and impaired functioning on a sessional basis. The principal investigator at the study site will collect information regarding attendance to therapy, dropout rates, and 'stepping' clients up to higher-intensity therapies as primary outcomes.

연구 유형

중재적

등록 (예상)

단계

해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

영국
- North Yorkshire
  - Harrogate, North Yorkshire, 영국, hg12pw
    - Harrogate IAPT Service

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

설명

Inclusion Criteria:

Accepted for Behavioural Activation guided self-help intervention for depression with study NHS IAPT site.
Over age 18.
Adequate English ability.

Exclusion Criteria:

Not suitable for Behavioural Activation guided self-help intervention for depression with study NHS IAPT site.
Inadequate English ability.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

주 목적: 치료
할당: 무작위
중재 모델: 병렬 할당
마스킹: 없음(오픈 라벨)

팔의 수

무기와 개입

참가자 그룹 / 팔	개입 / 치료
활성 비교기: Treatment as Usual Participants randomised to the 'treatment as usual' group will receive behavioural activation guided-self help intervention as routinely delivered in the service.	행동: Treatment as Usual (Behavioural Activation) Clients will engage in treatment as usual. This involves low-intensity guided self-help behavioural activation for depression.
실험적: Treatment with Security Prime Participants randomised to the experimental group will receive behavioural activation guided self-help intervention as is routinely delivered in the service with additional attachment security priming intervention.	행동: Treatment as Usual with Security Prime In addition to their treatment as usual (low-intensity guided self-help behavioural activation for depression), participants will complete an initial attachment security priming task during the first session with their allocated clinician. Participants will be prompted in their intervention workbook with a caption regarding what a secure attachment relationship represents. They will be asked to think of a person/ people with whom they feel they have this relationship, and list them. Following this, they are asked to plot these individuals on a diagram of concentric circles in relation to how close they feel this person is to them. The closer to the middle of the diagram the individual places each person, the closer they feel their relationship to that person is. Prior to each session with their clinician, they will be prompted to complete a repeated security priming task in order to increase feelings of security prior to therapy sessions.

참가자 그룹 / 팔

개입 / 치료

활성 비교기: Treatment as Usual

Participants randomised to the 'treatment as usual' group will receive behavioural activation guided-self help intervention as routinely delivered in the service.

행동: Treatment as Usual (Behavioural Activation)

Clients will engage in treatment as usual. This involves low-intensity guided self-help behavioural activation for depression.

실험적: Treatment with Security Prime

Participants randomised to the experimental group will receive behavioural activation guided self-help intervention as is routinely delivered in the service with additional attachment security priming intervention.

행동: Treatment as Usual with Security Prime

In addition to their treatment as usual (low-intensity guided self-help behavioural activation for depression), participants will complete an initial attachment security priming task during the first session with their allocated clinician. Participants will be prompted in their intervention workbook with a caption regarding what a secure attachment relationship represents. They will be asked to think of a person/ people with whom they feel they have this relationship, and list them. Following this, they are asked to plot these individuals on a diagram of concentric circles in relation to how close they feel this person is to them. The closer to the middle of the diagram the individual places each person, the closer they feel their relationship to that person is.

Prior to each session with their clinician, they will be prompted to complete a repeated security priming task in order to increase feelings of security prior to therapy sessions.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Attendance 기간: Up to 8 weeks from the beginning to end of treatment	Number of therapy appointments booked versus number attended for each participant	Up to 8 weeks from the beginning to end of treatment
Dropout 기간: Up to 8 weeks from the beginning to end of treatment	Number of participants who drop out of therapy after attending at least one session of treatment	Up to 8 weeks from the beginning to end of treatment
Stepping-up to higher intensity services 기간: Up to 8 weeks from the beginning to end of treatment	The number of participants in the study who are referred for a higher intensity form of therapy during their low-intensity therapy	Up to 8 weeks from the beginning to end of treatment

2차 결과 측정

결과 측정	측정값 설명	기간
The Patient Health Questionnaire 9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001) 기간: Weekly for up to 8 weeks from the beginning to end of treatment	Self-report measure of depression with total possible score ranging from 0 to 27. Scores of 0-4 indicate minimal depression; 5-9 indicates mild depression; 10-14 indicates moderate depression; 15-19 indicates moderately severe depression; and 20-17 indicates severe depression.	Weekly for up to 8 weeks from the beginning to end of treatment
The Generalized Anxiety Disorder 7 (GAD-7; Spitzer, Kroenke, Williams, & Lower, 2006) 기간: Weekly for up to 8 weeks from the beginning to end of treatment	Self-report measure of anxiety with total possible scores between 0 to 21. Scores of 0-5 indicate mild anxiety; 6-10 indicates moderate anxiety; 11-15 indicates moderately severe anxiety; and 16-20 indicates severe anxiety.	Weekly for up to 8 weeks from the beginning to end of treatment
The Work and Social Adjustment Scale (WSAS; Mundt, Shear, & Greist, 2002) 기간: Weekly for up to 8 weeks from the beginning to end of treatment	Self-report measure of impaired functioning with total possible scores of between 0-20. Scores below 10 are associated with subclinical populations. Scores between 10 and 20 indicate significant functional impairment but less severe clinical symptomatology. Scores above 20 indicate moderately severe or worse psychopathology.	Weekly for up to 8 weeks from the beginning to end of treatment

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Sheffield

수사관

수석 연구원: James Walton, Harrogate IAPT Service

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (예상)

2019년 8월 1일

기본 완료 (예상)

2019년 10월 1일

연구 완료 (예상)

2019년 10월 1일

연구 등록 날짜

최초 제출

2019년 6월 17일

QC 기준을 충족하는 최초 제출

2019년 7월 13일

처음 게시됨 (실제)

2019년 7월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 7월 17일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 7월 13일

마지막으로 확인됨

2019년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

249633

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Treatment as Usual (Behavioural Activation)에 대한 임상 시험

Fondazione I.R.C.C.S. Istituto Neurologico Carlo...

모병

입원 중 환자와 간병인에게 웹을 통해 전달되는 마음챙김 프로그램의 타당성 및 효과. (KIMPO)

만성 편두통; 다발성 경화증; 운동 신경 질환

이탈리아
Hallym University Medical Center

아직 모집하지 않음

자살 위험에 처한 청소년을 위한 텍스트 기반 표현적 글쓰기 프로그램 (WRITE-SAFE)

자살 생각 | 자해 행위 | 자살 위험 | 청소년 정신 건강
Universitätsklinikum Hamburg-Eppendorf
Wuerzburg University Hospital; University of Kassel; University Düsseldorf

모병

진행성 암환자의 실존적 고통: 단기 정신역동적 심리치료(ORPHYS)와 일반 치료(TAU) 비교

진행성 암, 다양함, NOS

독일
Massachusetts General Hospital
National Institutes of Health (NIH); Samaritans of Boston

아직 모집하지 않음

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자살 생각 | 자살 시도 | 자살
US Department of Veterans Affairs

완전한

사전 지시서 작성 활성화 (EADCRAV)

사전 지시서

미국
Training and Implementation Associates

모병

FTTIP(Family Therapy Training and Implementation Platform): 장기 진료 개선을 위한 혁신적인 웹 기반 도구

전통적인 대면 교육 | FTTIP(가족 치료 교육 및 구현 플랫폼)

미국

Priming Attachment Security Within an IAPT Setting