跳至主要内容
临床试验/NCT06038747
NCT06038747已完成不适用

Investigating the Impact of Regular Self-monitoring and Reflecting on Affective Reactions Toward the Psychotherapist on Treatment Outcomes: A Randomized Controlled Trial Protocol.

University of North Carolina, Chapel Hill4 个研究点 分布在 1 个国家目标入组 520 人开始时间: 2023年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
520
试验地点
4
主要终点
Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Subjective well-being deficits) from 5 weeks to 10 weeks

研究概览

简要总结

The primary objective of this randomized controlled trial is to examine the influence of a brief post-session battery, designed to foster patient self-monitoring and reflection on their emotional reactions toward their psychotherapist, on the quality of the therapeutic relationship and treatment outcomes.

详细描述

The quality of the therapeutic relationship is critical in determining psychotherapy outcomes. However, facilitating patients' self-awareness and reflection on their affective responses to their therapist remains understudied as a potential tool for enhancing this relationship and subsequent treatment outcomes. The primary objective of this study is to examine the influence of a brief post-session battery, designed to foster patient self-monitoring and reflection on their emotional reactions toward their psychotherapist, on the quality of the therapeutic relationship and treatment outcomes. Using an observational randomized control trial design, participants will be allocated into intervention and control groups. Those in the intervention group will complete a postsession battery following each therapy session, while the control group will only undergo regular treatment. Data collection will be facilitated through the Qualtrics online survey software and span baseline, mid-trial (5th week), and end-of-trial (10th week) assessments.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • being aged 18 years or older,
  • being fluent in English,
  • being currently under individual psychotherapy with a minimum frequency of two sessions per month.

排除标准

  • having a legal guardian.

结局指标

主要结局

Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Subjective well-being deficits) from 5 weeks to 10 weeks

时间窗: 5 weeks, 10 weeks.

Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of change in psychotherapy. The subjective well-being subscale score ranges 0-16). Higher scores represent poorer subjective well-being.

Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Problems/symptoms) from baseline to 5 weeks

时间窗: Baseline, 5 weeks.

Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of change in psychotherapy. The problems/symptoms subscale score ranges 0-48). Higher scores represent greater problems/symptoms.

Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Life functioning difficulties) from baseline to 5 weeks

时间窗: Baseline, 5 weeks.

Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of change in psychotherapy. The life functioning difficulties subscale score ranges 0-48). Higher scores represent greater life functioning difficulties.

Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Life functioning difficulties) from baseline to 10 weeks

时间窗: Baseline, 10 weeks.

Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of change in psychotherapy. The life functioning difficulties subscale score ranges 0-48). Higher scores represent greater life functioning difficulties.

Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Risk/harm) from baseline to 10 weeks

时间窗: Baseline, 10 weeks.

Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of change in psychotherapy. The risk/harm subscale score ranges 0-26). Higher scores represent greater risk/harm.

Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Risk/harm) from 5 weeks to 10 weeks

时间窗: 5 weeks, 10 weeks.

Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of change in psychotherapy. The risk/harm subscale score ranges 0-26). Higher scores represent greater risk/harm.

Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Total score) from baseline to 5 weeks

时间窗: Baseline, 5 weeks

Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a 34-item self-report measure of change in psychotherapy. Total score ranges 0-136. Higher scores represent poorer overall functioning.

Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Total score) from baseline to 10 weeks

时间窗: Baseline, 10 weeks

Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a 34-item self-report measure of change in psychotherapy. Total score ranges 0-136. Higher scores represent poorer overall functioning.

Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Total score) from 5 weeks to 10 weeks

时间窗: 5 weeks, 10 weeks.

Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a 34-item self-report measure of change in psychotherapy. Total score ranges 0-136. Higher scores represent poorer overall functioning.

Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Subjective well-being deficits) from baseline to 5 weeks

时间窗: Baseline, 5 weeks.

Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of change in psychotherapy. The subjective well-being subscale score ranges 0-16). Higher scores represent poorer subjective well-being.

Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Subjective well-being deficits) from baseline to 10 weeks

时间窗: Baseline, 10 weeks.

Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of change in psychotherapy. The subjective well-being subscale score ranges 0-16). Higher scores represent poorer subjective well-being.

Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Problems/symptoms) from baseline to 10 weeks

时间窗: Baseline, 10 weeks.

Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of change in psychotherapy. The problems/symptoms subscale score ranges 0-48). Higher scores represent greater problems/symptoms.

Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Problems/symptoms) from 5 weeks to 10 weeks

时间窗: 5 weeks, 10 weeks.

Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of change in psychotherapy. The problems/symptoms subscale score ranges 0-48). Higher scores represent greater problems/symptoms.

Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Life functioning difficulties) from 5 weeks to 10 weeks

时间窗: 5 weeks, 10 weeks.

Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of change in psychotherapy. The life functioning difficulties subscale score ranges 0-48). Higher scores represent greater life functioning difficulties.

Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Risk/harm) from baseline to 5 weeks

时间窗: Baseline, 5 weeks.

Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of change in psychotherapy. The risk/harm subscale score ranges 0-26). Higher scores represent greater risk/harm.

次要结局

  • Working Alliance Inventory-Short Revised (Goal)(Up to 10 weeks.)
  • Working Alliance Inventory-Short Revised (Bond)(Up to 10 weeks.)
  • Working Alliance Inventory-Short Revised (Total score)(Up to 10 weeks.)
  • Real Relationship Inventory-Client-Short form (Total score)(Up to 10 weeks.)
  • Real Relationship Inventory-Client-Short form (Genuineness)(Up to 10 weeks.)
  • Real Relationship Inventory-Client-Short form (Realism)(Up to 10 weeks.)
  • Working Alliance Inventory-Short Revised (Task)(Up to 10 weeks.)
  • Number of sessions missed or canceled(Up to 10 weeks.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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