Self-monitoring and Reflection's Impact on Psychotherapy Outcomes: A Trial Protocol.

Not Applicable

Completed

• Conditions: Psychotherapy; Therapeutic Alliance; Psychological
• Interventions: Other: Individual Psychotherapy; Other: Self-Monitoring

• Registration Number: NCT06038747
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-09-06
• Study First Submitted QC: 2023-09-08
• Study Start: 2023-09-15
• Study First Posted: 2023-09-15
• Primary Completion: 2024-01-23
• Study Completion: 2024-01-23
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-15
• Last Update Posted: 2024-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 520

Inclusion Criteria

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

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Exclusion Criteria

• having a legal guardian.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Individual Psychotherapy	Individual Psychotherapy	Participants in the control group will receive only treatment as usual (i.e., individual psychotherapy) sand and will not complete post-session questionnaires. Additionally, they will not receive any feedback at all encouraging them to discuss their emotional responses with their therapist during the session.
Individual Psychotherapy + Self-Monitoring	Self-Monitoring	Participants in the intervention group will continue their regular individual psychotherapy sessions. Additionally, after each session, they will complete a brief postsession battery consisting of two scales on the affective reactions of the participants towards their therapist during session and read general feedback encouraging them to discuss their feelings and reflections with their therapist. This questionnaire aims to prompt reflection on the own experience of the therapeutic relationship.
Individual Psychotherapy + Self-Monitoring	Individual Psychotherapy	Participants in the intervention group will continue their regular individual psychotherapy sessions. Additionally, after each session, they will complete a brief postsession battery consisting of two scales on the affective reactions of the participants towards their therapist during session and read general feedback encouraging them to discuss their feelings and reflections with their therapist. This questionnaire aims to prompt reflection on the own experience of the therapeutic relationship.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Working Alliance Inventory-Short Revised (Goal)	Up to 10 weeks.	Measure of the working alliance between a therapist and participant from the participant's viewpoint. The Working Alliance Inventory-Short Revised (WAI-SR) is a 12-item self-report measure of the quality of the working alliance. The Goal subscale (3 items) score ranges 0-18. Higher scores indicate a stronger agreement on the tasks of therapy. It will be assessed at baseline, mid-trial (5 weeks), and end-of-trial (10 weeks).
Working Alliance Inventory-Short Revised (Bond)	Up to 10 weeks.	Measure of the working alliance between a therapist and participant from the participant's viewpoint. The Working Alliance Inventory-Short Revised (WAI-SR) is a 12-item self-report measure of the quality of the working alliance. The Bond subscale score (3 items) ranges 0-18. Higher scores indicate a stronger affective bond between the patient and the therapist. It will be assessed at baseline, mid-trial (5 weeks), and end-of-trial (10 weeks).
Working Alliance Inventory-Short Revised (Total score)	Up to 10 weeks.	Measure of the working alliance between a therapist and participant from the participant's viewpoint. The Working Alliance Inventory-Short Revised (WAI-SR) is a 12-item self-report measure of the quality of the working alliance and includes three subscales: goal, task, and bond. Total score ranges 0-72. Higher scores indicate a stronger alliance. It will be assessed at baseline, mid-trial (5 weeks), and end-of-trial (10 weeks).
Real Relationship Inventory-Client-Short form (Total score)	Up to 10 weeks.	Measure of the real relationship between a therapist and participant from the participant's viewpoint. The Real Relationship Inventory-Client-Short form (RRI-C-SF) is an 8-item self-report measure of the quality of the real relationship and includes two subscales: Genuineness and Realism, both of which represent closely related dimensions of authenticity and perceptual accuracy within the therapeutic relationship. Total score ranges 0-40. Higher scores represent better quality of the real relationship. It will be assessed at baseline, mid-trial (5 weeks), and end-of-trial (10 weeks).
Real Relationship Inventory-Client-Short form (Genuineness)	Up to 10 weeks.	Measure of the real relationship between a therapist and participant from the participant's viewpoint. The Real Relationship Inventory-Client-Short form (RRI-C-SF) is an 8-item self-report measure of the quality of the real relationship and includes two subscales: Genuineness and Realism, both of which represent closely related dimensions of authenticity and perceptual accuracy within the therapeutic relationship. The Genuineness subscale (3 items) score ranges 0-20. Higher scores represent higher perceived genuineness. It will be assessed at baseline, mid-trial (5 weeks), and end-of-trial (10 weeks).
Real Relationship Inventory-Client-Short form (Realism)	Up to 10 weeks.	Measure of the real relationship between a therapist and participant from the participant's viewpoint. The Real Relationship Inventory-Client-Short form (RRI-C-SF) is an 8-item self-report measure of the quality of the real relationship and includes two subscales: Genuineness and Realism, both of which represent closely related dimensions of authenticity and perceptual accuracy within the therapeutic relationship. The Realism subscale (4 items) score range 0-20. Higher scores represent higher perceived realism. It will be assessed at baseline, mid-trial (5 weeks), and end-of-trial (10 weeks).
Working Alliance Inventory-Short Revised (Task)	Up to 10 weeks.	Measure of the working alliance between a therapist and participant from the participant's viewpoint. The Working Alliance Inventory-Short Revised (WAI-SR) is a 12-item self-report measure of the quality of the working alliance. The Task subscale score (3 items) ranges 0-18. Higher scores indicate a stronger agreement on the tasks of therapy. It will be assessed at baseline, mid-trial (5 weeks), and end-of-trial (10 weeks).
Number of sessions missed or canceled	Up to 10 weeks.	Number of scheduled psychotherapy sessions that have been missed or canceled by the participant. It will be assessed at baseline, mid-trial (5 weeks), and end-of-trial (10 weeks).

Trial Locations

Locations (2)

Researchforme.Unc.Edu; 🇺🇸 Chapel Hill, North Carolina, United States

Researchmatch.Org; 🇺🇸 Chapel Hill, North Carolina, United States