NCT05612113

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

November 10, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

November 10, 2022

Status Verified

November 1, 2022

Enrollment Period

5 months

First QC Date

October 17, 2022

Last Update Submit

November 3, 2022

Conditions

Keywords

Clinical SupervisionTherapist CompetenceTraining and SupervisionLive SupervisionPsychotherapyBug-in-the-Ear

Outcome Measures

Primary Outcomes (3)

  • Therapist Rated Session Goal Attainment of Idiosyncratically Formulated Session Goals

    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

    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)

    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 Outcomes (4)

  • Patient rated degree of satisfaction and usefulness

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

  • Patient rated degree of collaboration with the therapist

    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

    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

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

Study Arms (2)

Baseline - Session Goal Formulation

ACTIVE COMPARATOR

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.

Other: Session Goal Formulation

Live Supervision with Bug-in-the-Ear (BITEar) as method

EXPERIMENTAL

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.

Behavioral: Live Supervision + Session Goal Formulation

Interventions

Read under "Arms"

Live Supervision with Bug-in-the-Ear (BITEar) as method

Read under "Arms"

Baseline - Session Goal Formulation

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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,
  • Being able to attend to regular treatment
  • Accepting recording of therapy sessions and providing a written consent
  • Above 16 years old

You may not qualify if:

  • a) Comorbid severe disorder such as schizophrenia, developmental disorder, severe eating disorder, or severe substance use disorder.
  • Therapists:
  • Licensed psychologist
  • Working in outpatient psychiatric care or primary care in Sweden
  • Currently providing CBT
  • At least one year work experience of providing psychological treatments in outpatient care
  • Supervisors:
  • At least 2 years experience working as a clinical supervisor for CBT
  • Formal supervision training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institute

Stockholm, Region Stockholm, 17177, Sweden

Location

Study Officials

  • Sven Alfonsson, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Third-party raters, not being involved in the project management of the study or participating in the study, will be blinded to the participating therapists, study phases and the order of recorded sessions. These third-party raters will assess therapists' skills, goal attainment and competences in each recorded session. To test for blinding integrity the third-party raters will note their guesses of which condition the session belonged to (baseline or intervention).
Purpose
OTHER
Intervention Model
SEQUENTIAL
Model Details: Replicated Single Case Experimental Design with Multiple Baselines
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

October 17, 2022

First Posted

November 10, 2022

Study Start

October 1, 2022

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

November 10, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations