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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05612113
Other study ID # 2022-00352-01
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 1, 2022
Est. completion date March 2023

Study information

Verified date November 2022
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 6
Est. completion date March 2023
Est. primary completion date March 2023
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Live Supervision + Session Goal Formulation
Read under "Arms"
Other:
Session Goal Formulation
Read under "Arms"

Locations

Country Name City State
Sweden Karolinska Institute Stockholm Region Stockholm

Sponsors (1)

Lead Sponsor Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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)
Primary 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 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) Approximately 14 weeks (from session 1 to session 14 with one session per week)
Secondary 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). Approximately 14 weeks (from session 1 to session 14 with one session per week)
Secondary 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. Approximately 14 weeks (from session 1 to session 14 with one session per week)
Secondary 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. Approximately 14 weeks (from session 1 to session 14 with one session per week)
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