Cognitive Behavioral Social Skills Training for Youth at Risk of Psychosis
2022年5月17日 更新者:Jean Addington, PhD、University of Calgary
Schizophrenia and other psychotic disorders are serious and debilitating mental illnesses that incur substantial suffering for patients and major challenges to the investigators health care and legal systems.
The prodrome is the period prior to onset of psychosis when functional decline and clinical symptoms gradually emerge.
The presence of a clinical high-risk (CHR) syndrome in young adults is associated with heightened risk (25-35%) for the later development of psychosis, and for those who do not necessarily go on to develop a psychotic illness, research has suggested that the majority continue to have fluctuating subthreshold symptoms and poor social and role functioning.
There are no specific treatments to help with these functional difficulties.
However, recent findings suggest that in people with schizophrenia, Cognitive Behavioral and Social Skills Training (CBSST) leads to significantly greater increase in the frequency of social functioning activities compared to treatment as usual or goal-focused supportive therapy, and preliminary data suggest CBSST is a feasible treatment for CHR.
This proposal is a competitive application for a three-site, longitudinal study aimed at testing the effectiveness and feasibility as well as mediators and mechanisms of action of a manualized CBSST intervention that will target functional difficulties associated with clinical risk states for psychosis.
The goals are 1) to examine whether CBSST compared to a placebo intervention (psychoeducation) matched for group involvement and therapist time improves functioning in youth at CHR and 2) to determine whether reduction in defeatist beliefs and improvement in social competence mediate change in psychosocial functioning in CHR youth in the CBSST.
In this single-blind randomized 2-arm trial participants will be randomized to one of two treatments: CBSST, an 18-week group comprised of three modules; 1) Cognitive Skills; 2) Social Skills; and 3) Problem Solving, or a psychoeducation support group that does not teach active cognitive behavioral therapy or social skills training.
Over a five-year period, the multi-site collaboration will follow large CHR sample that will undergo comprehensive assessments of psychosocial and behavioral changes, to examine changes in social and role functioning, as well as symptom changes from baseline to the end of treatment, and to 6 month follow-up.
This approach will demonstrate the feasibility of a treatment for which it is easy to train therapists and which can readily be disseminated to regular clinical community practice.
In addition, it will provide insights into likely approaches to halting or mitigating the pathological process and advance the investigators understanding of risk prediction; both critical steps in prevention.
調査の概要
研究の種類
介入
入学 (実際)
203
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Alberta
-
Calgary、Alberta、カナダ、T2N4Z6
- Mathison Centre for Research and Education, University of Calgary
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
14年~30年 (子、大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- have prodromal criteria in the past 4 years
- one attenuated psychotic symptom rated 3 or more
- rating on social functioning <6
Exclusion Criteria:
- meet criteria for a psychotic disorder neurological disorder IQ<70
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:単一グループの割り当て
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:Cognitive behavioral social skills
In Cognitive behavioral social skills training (CBSST), skills-based CBT is used to teach individuals how to correct inaccurate dysfunctional thoughts that interfere with goal-directed activities, including defeatist expectancies, low self-efficacy beliefs, and anomalous beliefs.
SST focuses on behaviorally-based instruction of interpersonal social skills, utilizing role-modeling, rehearsal, corrective feedback, and positive reinforcement to facilitate learning.
In the modified version of CBSST used in this project: 1) we will strengthen the focus on corrective feedback from successful social interactions; 2) focus on normalization and destigmatization of attenuated psychotic symptoms; 3) add motivational interviewing techniques to promote treatment engagement; and 4) use examples and role plays.
CBSST will be delivered in three 6-session modules (i.e., Cognitive Skills, Social Skills, and Problem Solving Skills), a total of 18 90-minute group sessions.
|
|
|
アクティブコンパレータ:Psychoeducation
The purpose of this alternative treatment is to match CBSST for the nonspecific effects of therapist contact and interest, social interaction and support.
Common factors include client expectancy, providing a rationale for change, therapist factors and therapeutic alliance.
The psychoeducation group will meet weekly, for a total of 18 90-minute sessions.
Therapists will follow brief guidelines as to what they can and cannot do.
In each session the therapists will ask how the previous week had been.
Any crises will be dealt with, and advice will be offered to help with any immediate problems.
No active CBT or SST techniques will be taught or used.
Psychoeducational information about high risk for psychosis will be offered.
There will be a focus on listening, reflecting and empathizing, and demonstrating uncritical acceptance and genuineness.
Social exchanges amongst participants will be encouraged.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in the Global Social Functioning Scale
時間枠:6 and 12 months
|
This is a clinical rating scale that will be given to all participants at baseline, then 6 months which is the end of treatment and then 6 months after the end of treatment so approximately 12 months after baseline to determine if there is an improvement in social functioning
|
6 and 12 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Defeatist Beliefs
時間枠:6 and 12 months
|
This is a clinical rating scale that will be administer at the end of treatment (6 months) and 6 months after the end of treatment (12 months).
This will be administered to all participants
|
6 and 12 months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者:Jean M Addington, PhD、University of Calgary
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2015年1月1日
一次修了 (実際)
2021年8月1日
研究の完了 (実際)
2021年8月1日
試験登録日
最初に提出
2014年9月3日
QC基準を満たした最初の提出物
2014年9月8日
最初の投稿 (見積もり)
2014年9月9日
学習記録の更新
投稿された最後の更新 (実際)
2022年5月24日
QC基準を満たした最後の更新が送信されました
2022年5月17日
最終確認日
2022年5月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- MH105178
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。