Clinical trial NCT06038747: Self-monitoring and Reflection's Impact on Psychotherapy Outcomes: A Trial Protocol.
Official title: Investigating the Impact of Regular Self-monitoring and Reflecting on Affective Reactions Toward the Psychotherapist on Treatment Outcomes: A Randomized Controlled Trial Protocol.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychotherapy
Therapeutic Alliance
Psychological
Keywords: Therapeutic Relationship
Routine Outcome Monitoring
Self-Monitoring and Reflection
Psychotherapy Outcome
Client Feedback
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: University of Pavia
name: European Commission
First posted: 2023-09-15
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial design. Allocation ratio of 1:1.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Total score) from baseline to 5 weeks
timeFrame: Baseline, 5 weeks
measure: Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Total score) from baseline to 10 weeks
timeFrame: Baseline, 10 weeks
measure: Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Total score) from 5 weeks to 10 weeks
timeFrame: 5 weeks, 10 weeks.
measure: Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Subjective well-being deficits) from baseline to 5 weeks
timeFrame: Baseline, 5 weeks.
measure: Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Subjective well-being deficits) from baseline to 10 weeks
timeFrame: Baseline, 10 weeks.
measure: Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Subjective well-being deficits) from 5 weeks to 10 weeks
timeFrame: 5 weeks, 10 weeks.
measure: Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Problems/symptoms) from baseline to 5 weeks
timeFrame: Baseline, 5 weeks.
measure: Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Problems/symptoms) from baseline to 10 weeks
timeFrame: Baseline, 10 weeks.
measure: Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Problems/symptoms) from 5 weeks to 10 weeks
timeFrame: 5 weeks, 10 weeks.
measure: Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Life functioning difficulties) from baseline to 5 weeks
timeFrame: Baseline, 5 weeks.
measure: Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Life functioning difficulties) from baseline to 10 weeks
timeFrame: Baseline, 10 weeks.
measure: Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Life functioning difficulties) from 5 weeks to 10 weeks
timeFrame: 5 weeks, 10 weeks.
measure: Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Risk/harm) from baseline to 5 weeks
timeFrame: Baseline, 5 weeks.
measure: Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Risk/harm) from baseline to 10 weeks
timeFrame: Baseline, 10 weeks.
measure: Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Risk/harm) from 5 weeks to 10 weeks
timeFrame: 5 weeks, 10 weeks.
Secondary outcomes:
measure: Real Relationship Inventory-Client-Short form (Total score)
timeFrame: Up to 10 weeks.
measure: Real Relationship Inventory-Client-Short form (Genuineness)
timeFrame: Up to 10 weeks.
measure: Real Relationship Inventory-Client-Short form (Realism)
timeFrame: Up to 10 weeks.
measure: Working Alliance Inventory-Short Revised (Total score)
timeFrame: Up to 10 weeks.
measure: Working Alliance Inventory-Short Revised (Goal)
timeFrame: Up to 10 weeks.
measure: Working Alliance Inventory-Short Revised (Task)
timeFrame: Up to 10 weeks.
measure: Working Alliance Inventory-Short Revised (Bond)
timeFrame: Up to 10 weeks.
measure: Number of sessions missed or canceled
timeFrame: Up to 10 weeks.
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Researchforme.Unc.Edu
state: North Carolina
city: Chapel Hill
country: United States
facility: Researchmatch.Org
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Alberto Stefana, PhD
role: PRINCIPAL_INVESTIGATOR
References: