Skip to main content
OpenTrials
Completed

NCT Number: NCT06038747

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Researchforme.Unc.Edu, Chapel Hill, North Carolina, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

  • having a legal guardian.

Treatment and study plan

Self-monitoring

Other

The post-session battery consists of two self-report scales measuring both positive and negative affective reactions of the participants toward their therapist during the therapy session. The general feedback is a brief text that encourages participants to share and discuss their feelings and reflections with their therapist.

Individual Psychotherapy

Other

Individual psychotherapy sessions

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

Secondary outcomes

  1. Real Relationship Inventory-Client-Short form (Total score)

    Time frame: 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).

  2. Real Relationship Inventory-Client-Short form (Genuineness)

    Time frame: 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).

  3. Real Relationship Inventory-Client-Short form (Realism)

    Time frame: 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).

  4. Working Alliance Inventory-Short Revised (Total score)

    Time frame: 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).

  5. Working Alliance Inventory-Short Revised (Goal)

    Time frame: 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).

  6. Working Alliance Inventory-Short Revised (Task)

    Time frame: 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).

  7. Working Alliance Inventory-Short Revised (Bond)

    Time frame: 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).

  8. Number of sessions missed or canceled

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • European Commission
  • University of Pavia

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 15, 2023
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.