CROP: Common Factors, Responsiveness and Outcome in Psychotherapy

Sponsor
The Common Factors, Responsiveness and Outcome of Psychotherapy Study (Other)
Overall Status
Recruiting
CT.gov ID
NCT05630560
Collaborator
University of Copenhagen (Other), The Health Foundation (Other), TRYG Foundation (Other), the Danish Psychological Association (Other)
1,000
1
66
15.2

Study Details

Study Description

Brief Summary

The "Common Factors, Responsiveness and Outcome of Psychotherapy" (CROP) study is a naturalistic observational study at the University of Copenhagen (UCPH) carried out in cooperation with psychologists in the Danish practice sector or in private practice. The study aims to examine the contribution of client, therapist and treatment characteristics, as well as the role of therapists' responsiveness, on the process and outcome of psychotherapy. Participating psychologists and clients fill out background questionnaires prior to initiating therapy, and process data for each course of treatment is collected weekly and after each session while outcome data is collected at end of treatment and at three months follow-up. The psychologists are reimbursed DKK 1,000 per client that contributes to the study with at least three session questionnaires, which corresponds to the hourly salary of a psychologist in Danish private practice. All data is collected through an automated, online database to ensure appropriate anonymization and data management, and all participants give informed consent prior to participation. The CROP study has been approved by the UCPH's Department of Psychology's ethical review board and the Danish Data Protection Agency.

Condition or Disease Intervention/Treatment Phase
  • Other: Psychotherapy treatment

Detailed Description

The aim of the Common factors, Responsiveness and Outcome in Psychotherapy study (CROP) is to determine client and psychologist characteristics and therapeutic processes associated with the outcome of psychotherapy delivered by psychologists in the Danish practice sector or in private practice. The study addresses two main questions. First, how are specific characteristics of clients and psychologists related to the outcome of therapy and do these characteristics moderate the outcome of different psychotherapeutic approaches? Second, to what extent do therapists adapt their approach to client characteristics and preferences and how does such responsiveness impact the process and outcome of therapy? The results from the study are directly relevant to psychologists and will be disseminated nationwide during and after the end of the study.

The study is a naturalistic, observational study carried out in collaboration with psychologists in the Danish practice sector or in private practice. Self-report data is collected on the participating psychologists and their participating clients before psychotherapy, during psychotherapy (weekly and post-session) and after psychotherapy (at end of treatment and three months follow-up). The data is analyzed using multilevel modeling and structural equation modeling approaches.

The study design and data management procedure have been approved by the Research Ethics Board of the Department of Psychology, University of Copenhagen, and the Danish Data Protection Agency. All data are fully anonymized and stored in agreement with the Danish Act on Processing of Personal Data. All parts of the study are based on the principles of informed consent and clients are informed that they can terminate their participation in the study at any time without consequences to their treatment. The findings of the study will be presented in articles in international, peer-reviewed journals as well as to psychotherapy practitioners across Denmark.

Study Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Common Factors, Responsiveness and Outcome in Psychotherapy (CROP): Study Protocol for an Observational Study of Psychotherapy in Private Practice
Actual Study Start Date :
Jan 1, 2019
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Psychologists in Danish private practice

All psychologists with a Danish university degree in psychology who have registered themselves as seeing clients in private practice (app. 1,750) have been invited to participate in the study. Thus, the sample of psychologists consists of psychologists employed in the Danish practice sector, where clients obtain a refund of 60% of the psychologist's salary, as well as psychologists working privately without any reimbursement of their salaries. Each psychologist enrolled in the study has agreed to aim to recruit no less than 10 clients each for the study. We aim to include 100 psychologists, which will yield a sample of 1,000 clients beginning therapy.

Other: Psychotherapy treatment
The psychotherapist will conduct psychotherapy as normally done by them in their practice. The treatment will thus be un-manualized and consist of a broad range of therapeutic orientations and treatment lengths.

Outcome Measures

Primary Outcome Measures

  1. Change in psychological symptoms measured by the BSI [Change in psychological symptoms from baseline until end-of-treatment (an average of 7 months).]

    The Brief Symptom Inventory (BSI) is a self-report scale consisting of 53 items covering nine symptom dimensions: Somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation and psychoticism.

Secondary Outcome Measures

  1. Change in symptoms measured by the Symptom Checklist-11 [Every week while the client is in therapy, up until 25 weeks of therapy.]

    Symptom Checklist-11 (SCL-11) is a short, multidimensional outcome measure for the evaluation of therapeutic progress in psychotherapy, consisting of 11 items selected from the BSI using a stepwise item selection procedure

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Above 18 of age and in individual psychotherapy
Exclusion Criteria:
  • severe psychoticism or other severe mental health issues.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Copenhagen Copenhagen Denmark 1353

Sponsors and Collaborators

  • The Common Factors, Responsiveness and Outcome of Psychotherapy Study
  • University of Copenhagen
  • The Health Foundation
  • TRYG Foundation
  • the Danish Psychological Association

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The Common Factors, Responsiveness and Outcome of Psychotherapy Study
ClinicalTrials.gov Identifier:
NCT05630560
Other Study ID Numbers:
  • 16-B-0269
First Posted:
Nov 29, 2022
Last Update Posted:
Nov 29, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by The Common Factors, Responsiveness and Outcome of Psychotherapy Study

Study Results

No Results Posted as of Nov 29, 2022