CompetenceNCT05612113
Live Supervision in Psychotherapy: Study Protocol for a Single Case Experimental Design Study (SCED)
A study testing Live Supervision + Session Goal Formulation and Session Goal Formulation in people with Competence, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Competence
- What is being tested?
- Live Supervision + Session Goal Formulation and Session Goal Formulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSweden
- Study dates
- 1 Oct 2022to Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
- Licensed psychologist
- Working in outpatient psychiatric care or primary care in Sweden
Show all 11Show fewer
- 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
Who cannot join
- Comorbid severe disorder such as schizophrenia, developmental disorder, severe eating disorder, or severe substance use disorder.
- Therapists:
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Competence
- Being tested
- Live Supervision + Session Goal Formulation, Session Goal Formulation
- Keywords
- Clinical Supervision, Therapist Competence, Training and Supervision, Live Supervision, Psychotherapy, Bug-in-the-Ear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live Supervision + Session Goal FormulationBehavioural
Read under "Arms"
Session Goal FormulationOther
Read under "Arms"
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Live Supervision + Session Goal Formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Approximately 14 weeks (from session 1 to session 14 with one session per week)
Secondary outcomes (4)
Patient rated degree of satisfaction and usefulness
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)
Measured: Approximately 14 weeks (from session 1 to session 14 with one session per week)
Patient rated degree of collaboration with the therapist
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).
Measured: 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
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.
Measured: 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
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.
Measured: Approximately 14 weeks (from session 1 to session 14 with one session per week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start1 Oct 2022
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CompetenceStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Replicated Single Case Experimental Design with Multiple Baselines
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sven Alfonsson, Karolinska Institutet
- Investigators
- Sven Alfonsson, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05612113
- Sponsor's protocol ID
- 2022-00352-01
- Status last verified
- Nov 2022
- First submitted
- 17 Oct 2022
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Live Supervision in Psychotherapy: Study Protocol for a Single Case Experimental Design Study (SCED) With Multiple Baselines in an Outpatient Clinical Setting
- ClinicalTrials.gov ID
- NCT05612113
- Acronym / sponsor ID
- 2022-00352-01
- Conditions
- Competence
- Keywords
- Clinical Supervision, Therapist Competence, Training and Supervision, Live Supervision, Psychotherapy, Bug-in-the-Ear
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 10 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Replicated Single Case Experimental Design with Multiple Baselines
| Arm | Type | Receives |
|---|---|---|
| Baseline - Session Goal Formulation | Active comparator | Other: Session Goal FormulationIn 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. |
| Live Supervision with Bug-in-the-Ear (BITEar) as method | Experimental | Behavioral: Live Supervision + Session Goal FormulationLS 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 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
- Licensed psychologist
Key exclusion criteria (2 listed)
- Comorbid severe disorder such as schizophrenia, developmental disorder, severe eating disorder, or severe substance use disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Live Supervision + Session Goal FormulationRead under "Arms" | Behavioural | Live Supervision with Bug-in-the-Ear (BITEar) as method |
| Session Goal FormulationRead under "Arms" | Other | Baseline - Session Goal Formulation |
Primary outcome
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.
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.
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.
4 secondary outcomes
Patient rated degree of satisfaction and usefulness
Time frame: 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)
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sven Alfonsson, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Live Supervision + Session Goal Formulation and Session Goal Formulation in people with Competence, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2022.