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

November 15, 2024 updated by: University of North Carolina, Chapel Hill

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
520

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Alberto Stefana, PhD
  • Phone Number: +393381131304
  • Email: astefana@unc.edu

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Researchforme.Unc.Edu
      • Chapel Hill, North Carolina, United States, 27599
        • Researchmatch.org

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Individual Psychotherapy + 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.
Other: Self-Monitoring
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.
Other: Individual Psychotherapy
Individual psychotherapy sessions
Active Comparator: 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.
Other: Individual Psychotherapy
Individual psychotherapy sessions

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 5 weeks
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.
Baseline, 10 weeks
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.
5 weeks, 10 weeks.
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.
Baseline, 5 weeks.
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.
Baseline, 10 weeks.
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.
5 weeks, 10 weeks.
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.
Baseline, 5 weeks.
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.
Baseline, 10 weeks.
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.
5 weeks, 10 weeks.
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.
Baseline, 5 weeks.
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.
Baseline, 10 weeks.
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.
5 weeks, 10 weeks.
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.
Baseline, 5 weeks.
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.
Baseline, 10 weeks.
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.
5 weeks, 10 weeks.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
Up to 10 weeks.
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).
Up to 10 weeks.
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).
Up to 10 weeks.
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).
Up to 10 weeks.
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).
Up to 10 weeks.
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).
Up to 10 weeks.
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).
Up to 10 weeks.
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).
Up to 10 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of North Carolina, Chapel Hill

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Pavia
European Commission

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alberto Stefana, PhD, University of North Carolina, Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 23, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 23, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 6, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 15, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 23-1067

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina at Chapel Hill.

IPD Sharing Time Frame

The Study protocol article will be published before data collection completion. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following the publication of the research reports.

IPD Sharing Access Criteria

Investigator has approved IRB, IEC), or REB and an executed data use/sharing agreement with the University of North Carolina at Chapel Hill.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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