Live Supervision in Psychotherapy: Study Protocol for a Single Case Experimental Design Study (SCED)

November 3, 2022 updated by: Sven Alfonsson, Karolinska Institutet

Live Supervision in Psychotherapy: Study Protocol for a Single Case Experimental Design Study (SCED) With Multiple Baselines in an Outpatient Clinical Setting

Although clinical supervision is an essential part of psychotherapy training and development, the empirical evidence for effects on therapist competence and patient outcome is limited. However, a novel format, Live Supervision (LS), enables real time feedback during the patient session which counteracts on several of the major identified problems with standard supervision. Pilot studies of LS show promising results, but the effects of LS has never been assessed in a clinical setting with licensed psychologists. Furthermore, manualized LS with a stringent focus at therapists' idiosyncratic challenges has never been evaluated.

The primary aim of this study is to evaluate the effects of LS on therapist competence and perceived therapy challenges in a clinical outpatient setting with licensed psychologists as therapists. Secondary aims are to examine when and how LS is optimal for clinical supervision.

Study Overview

Detailed Description

Objective:

To evaluate the effects of LS on therapist competence and perceived therapy challenges with both qualitative and quantitative data in a sample of licensed psychotherapists working with CBT in outpatient psychiatry or primary care.

Methods:

The study will use a replicated Single Case Experimental Design (SCED) with randomized multiple baselines in combination with qualitative interviews at the end of the trial. Each therapist (n = 6) will take part in the study with one patient for a period of 14 therapy sessions of which 5-9 sessions (randomized for each therapist) consist of the baseline phase, followed by the intervention phase (Live Supervision) for the rest of the study period (5-9 sessions).

Primary outcome measures will be observer rated competence and observer and therapist rated goal attainment. Secondary outcome measure will be the quality of therapy sessions from the perspective of the patients and observer rated competence according to the supervisors perception of the most prevalent skill deficiency of the therapist.

The qualitative data collection will focus on a systemization of how and when LS is for optimal use as well as mapping the degree of correspondence between patients, therapists, and supervisors regarding the therapists competences and skill deficiencies.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • 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 Locations

    • Region Stockholm
      • Stockholm, Region Stockholm, Sweden, 17177
        • Karolinska Institute

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

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Patients:

Inclusion Criteria:

  1. At least one diagnosis of the following DSM-5 disorders: mood disorders, anxiety disorders, OCD or related disorders, orTrauma or stress related disorders, comorbid severe disorder such as schizophrenia or development disorder,
  2. Being able to attend to regular treatment
  3. Accepting recording of therapy sessions and providing a written consent
  4. Above 16 years old

Exclusion Criteria:

a) Comorbid severe disorder such as schizophrenia, developmental disorder, severe eating disorder, or severe substance use disorder.

Therapists:

Inclusion criteria:

  1. Licensed psychologist
  2. Working in outpatient psychiatric care or primary care in Sweden
  3. Currently providing CBT
  4. At least one year work experience of providing psychological treatments in outpatient care

Supervisors:

Inclusion criteria:

  1. At least 2 years experience working as a clinical supervisor for CBT
  2. Formal supervision training

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: Other
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Baseline - Session Goal Formulation

In the baseline phase, the therapist will formulate two session goals, see under descriptions of primary outcome measure.

In this SCED-study, the baseline phase will be of randomized length (5-9 sessions) for each therapist.

The reason for defining this as an active comparator is that we the behavior of formulating two session goals before each session should be considered an intervention, stimulating the therapist to reflect on the upcoming session goals, on defining concrete behaviors to reach the session goal, and to reflect upon his/her session behaviors afterwards. Thus, regarding the baselinephase as a no intervention would be misleading.

Read under "Arms"
Experimental: Live Supervision with Bug-in-the-Ear (BITEar) as method

LS with the Bug-in-the-Ear (BITEar) is a video based supervision format where the supervisor watches the therapy session live through a webcam in the therapy room. During the therapy session, the supervisor provide verbal feedback and guidance to the therapist who wears wireless in-ear headphones.

In this SCED-study, the intervention phase consist of 5 to 9 BITEar supervision sessions (number of supervision sessions is randomized between therapists)

The BITEar supervision will consist of three phases:

Pre-supervision (15 minutes): Discussion of the therapists session goals, how the therapist wants the supervisor's help and agreement on prompts and cues from supervisor

Live supervision during the therapy session (≈ 45-60 minutes): Supervisor gives real time feedback and guidance focusing on helping the therapist achieve session goals

Post-supervision (15 minutes): Reflection about the session, session goals and the supervision.

Read under "Arms"

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Therapist Rated Session Goal Attainment of Idiosyncratically Formulated Session Goals
Time Frame: Approximately 14 weeks (from session 1 to session 14 with one session per week)

All therapists will formulate two individual development goals per therapy session for the 14 weeks. One goal is focusing on a challenging behavioral pattern of the patient (e.g. talkative), and the other focusing on a challenging behavior of the therapist (e.g. being concise).

After each session, each therapist rates to what degree they perceived that they managed to reach each of their set up goals on a scale from 0 (not reached the goal at all) to 100 (fully reached the goal) with 5 anchor points with descriptions. They will also rate the perceived difficulty of working with the goal from a scale from 0 (not at all difficult) to 100 (extremely difficult) with 5 anchor points with descriptions.

Approximately 14 weeks (from session 1 to session 14 with one session per week)
Observer Rated Session Goal Attainment of Idiosyncratically Formulated Session Goals
Time Frame: Approximately 14 weeks (from session 1 to session 14 with one session per week)
Third-party raters will listen to the audio recordings of the sessions and evaluate the level of goal attainment in each session, blinded to whether the therapist received supervision or not. Observers will be trained in how to evaluate goal attainment.
Approximately 14 weeks (from session 1 to session 14 with one session per week)
Therapist Competence measured with Cognitive Therapy Scale - Revised (CTS-R; Blackburn et al., 2001)
Time Frame: Approximately 14 weeks (from session 1 to session 14 with one session per week)

The CTS-R instrument is one of the most used and validated scales for measuring CBT competence. The scale consists of 12 items with a 7-point rating scale format: 0 = poor, 1 = barely adequate, 2 = mediocre, 3 = satisfactory, 4 = good, 5 = very good, and 6 = excellent.

In this study, we will analyze both the composite score of the full scale, but also an item per item analysis since one of the aims of the study is to assess for what type of competencies LS may be particularly effective.

Approximately 14 weeks (from session 1 to session 14 with one session per week)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient rated degree of satisfaction and usefulness
Time Frame: Approximately 14 weeks (from session 1 to session 14 with one session per week)
Each session, the patient will rate how satisfied and how useful they perceived the session. The rating is on a scale from 0 (not at all) to 100 (extremely)
Approximately 14 weeks (from session 1 to session 14 with one session per week)
Patient rated degree of collaboration with the therapist
Time Frame: Approximately 14 weeks (from session 1 to session 14 with one session per week)
As a proxy measure for therapeutic alliance, a single item will be used where the patient is asked to rate how they perceived the collaboration with their therapist on a scale from 0 (not good at all) to 100 (extremely good).
Approximately 14 weeks (from session 1 to session 14 with one session per week)
Observer rated degree of therapist skill deficiency as defined by the supervisor
Time Frame: Approximately 14 weeks (from session 1 to session 14 with one session per week)
During the interviews in the end of the trial, the supervisors will be asked to define the most important therapist skill deficiency. This skill will then be operationalized and rated for each session by a blinded third party rater.
Approximately 14 weeks (from session 1 to session 14 with one session per week)
Observer rated degree of therapist skill deficiency as defined by the patient
Time Frame: Approximately 14 weeks (from session 1 to session 14 with one session per week)
During the interviews in the end of the trial, the patients will be asked to define the most important therapist skill deficiency. This skill will then be operationalized and rated for each session by a blinded third party rater.
Approximately 14 weeks (from session 1 to session 14 with one session per week)

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Sven Alfonsson, PhD, Karolinska Institutet

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)

October 1, 2022

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

October 17, 2022

First Submitted That Met QC Criteria

November 3, 2022

First Posted (Actual)

November 10, 2022

Study Record Updates

Last Update Posted (Actual)

November 10, 2022

Last Update Submitted That Met QC Criteria

November 3, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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