- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05366998
Therapeutic Alliance and Treatment Outcome
December 5, 2023 updated by: Cosima Locher, Privatklinik Hohenegg
Therapeutic Alliance and Treatment Outcome: A Study of the Private Clinic Hohenegg
This study aims to inform scientific understanding of the impact of the therapeutic alliance and the transition from inpatient to outpatient care.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
102
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Locher
- Phone Number: (+41) 0794613254
- Email: cosimaantoinette.locher@uzh.ch
Study Locations
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Zürich
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Meilen, Zürich, Switzerland, 8706
- Privatklinik Hohenegg
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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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
All Patients who are admitted to the PKH.
The PKH is a Swiss clinic with 70 beds, located in a rural setting.
It treats patients in an inpatient setting for the following psychiatric disorders: depression, burnout, anxiety and psychosomatic disorders.
Description
Inclusion Criteria:
- All patients admitted to in-patient treatment in the private psychiatric clinic Hohenegg (PKH) from November 2021 onwards
Exclusion Criteria:
- Due to the naturalistic approach of the study, there will be no selection or exclusion made
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline psychological distress on Brief Symptom Checklist (BSCL, German version) at post-treatment and follow-up
Time Frame: Baseline, post-treatment (after 6-8 weeks) and follow-up (after 2-4 months)
|
The BSCL is a 53-item self-report questionnaire that measures psychological distress and symptoms in the last seven days.
Each item is rated on a 5-point Likert scale ranging from 0 = "not at all" to 4 = "extremely".
The BSCL consists of nine different subscales: somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism.
Moreover, three global indices can be calculated: The Global Severity Index (GSI), providing information on psychological distress, the Positive Symptom Distress Index (PSDI), measuring the intensity of the reported symptoms, and the Positive Symptom Total (PST), indicating the number of present symptoms.
|
Baseline, post-treatment (after 6-8 weeks) and follow-up (after 2-4 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline quality of life on short version of the Incongruence Questionnaire (K-INK) at post-treatment and follow-up.
Time Frame: Baseline, post-treatment (after 6-8 weeks) and follow-up (after 2-4 months)
|
The K-INK is a 23-item questionnaire and was developed as a short version of the INK with 93 items.
It is based on the psychological construct of incongruence which is described as unsatisfactory realization of personal goals.
These goals are based on the four basic psychological human needs, defined by Grawe, 1998 (Orientation and Control, Pleasure and Avoidance of pain, Self-Enhancement, Attachment).
The items enquire information respective to these needs and are grouped in 14 respectively 9 scales: approach driven goals (one item per scale in the K-INK) and avoidance driven goals (one item per scale in the K-INK).
Each item is rated on a 5-point Likert scale ranging from 0 = "(too) little" to 4 = "sufficient/satisfactory".
|
Baseline, post-treatment (after 6-8 weeks) and follow-up (after 2-4 months)
|
Change from baseline quality of life on the short version of the World Health Organization Quality of Life Instrument-Abbreviated Version (EUROHIS-QOL, German version) at post-treatment and follow-up
Time Frame: Baseline, post-treatment (after 6-8 weeks) and follow-up (after 2-4 months)
|
The EUROHIS-QOL 8-Item Index is a short version of the WHOQOL-BREF containing 26 items grouped in four domains: physical, psychological, social relationships and environment.
The EUROHIS-QOL 8-Item Index is composed of 2 items for each domain.
The items are answered on a 5-point scale.
|
Baseline, post-treatment (after 6-8 weeks) and follow-up (after 2-4 months)
|
Change from post-treatment therapeutic alliance (inpatient treatment) on the short version of the Working Alliance Inventory - short revised (WAI-SR, German version) at follow-up (outpatient treatment)
Time Frame: Post-treatment (after 6-8 weeks) and follow-up (after 2-4 months)
|
The WAI is a 12-item self-report questionnaire that measures the quality of alliance based on the following three aspects: the bond, the agreement on goals and the agreement on tasks.
Each item is rated on a 5-point Likert scale ranging from 0 = "never" to 5 = "always".
The WAI provides three subscales: bond, tasks and goals and one total scale.
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Post-treatment (after 6-8 weeks) and follow-up (after 2-4 months)
|
Perceived social support in inpatient setting at post-treatment on the Fellow Patient Social Support (FEPB)
Time Frame: Post-treatment (after 6-8 weeks)
|
The FEPB is a self-reported questionnaire and measures various aspects of the patient's social network during the clinical stay.
In our study, we will use the 11th section, which assesses the overall impression of all relationships with fellow patients.
The 11th section contains of eight items, whereby we will exclude item 4 and item 6 , because they do not fit the clinical.received
by or due to fellow patients, each rated on a 5-point Likert scale ranging from 0 = "not at all" to 4 = "very much", as well as an item with an open question to qualitatively assess perceived support and distress from fellow patients.
Moreover, the influence of fellow patients on treatment outcome is rated on a 5-point Likert scale from 0 = "very much worse" to 4 = "very much improved".
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Post-treatment (after 6-8 weeks)
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Perceived social support in outpatient setting at follow-up on the short version Social Support Questionnaire (F-SozU K-14, German Version)
Time Frame: follow-up (after 2-4 months)
|
The F-SozU is a 14-item, self-reported questionnaire that measures perceived social support, whereby each item is rated on a 5-point Likert scale ranging from 1 = "not at all" to 5 = "completely".
The questionnaire provides a global scale to assess the perceived social support based on emotional support, practical support and social integration.
|
follow-up (after 2-4 months)
|
Perceived helpfulness of therapy for therapist effect at post-treatment on a single item
Time Frame: Post-treatment (after 6-8 weeks)
|
A single item, about the helpfulness of the different forms of therapy, rated on a 7-point Likert scale ranging from "not at all" to "extremely".
|
Post-treatment (after 6-8 weeks)
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Perceived experience of loneliness at follow-up on the short version of the UCLA loneliness scale (UCLA, German version)
Time Frame: follow-up (after 2-4 months)
|
The UCLA short version is a self-reported questionnaire that measures the feeling of loneliness with three items, each of which rated on a 3-point Likert scale ranging from 1 = "hardly ever" to 3 = "often".
The UCLA yields a single scale, with higher scores indicating higher levels of loneliness.
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follow-up (after 2-4 months)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived experience of the transition from the inpatient to the outpatient setting at post-treatment on a qualitative item
Time Frame: Post-treatment (after 6-8 weeks)
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A qualitative item about fears related to the transition to outpatient treatment.
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Post-treatment (after 6-8 weeks)
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Perceived experience of the transition from the inpatient to the outpatient setting at follow-up on qualitative items (Questions in this form are minimally adapted without changing intention due to the limited characters)
Time Frame: follow-up (after 2-4 months)
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14 qualitative items about
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follow-up (after 2-4 months)
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Additional demographics; previous inpatient settings and significant events after the clinic at follow-up on qualitative items
Time Frame: follow-up (after 2-4 months)
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Two qualitative items, one about previous inpatient treatment experiences and the other about significant events after the treatment in the PKH.
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follow-up (after 2-4 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Cosima A. Locher, Dr. phil., Privatklinik Hohenegg
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)
November 1, 2021
Primary Completion (Actual)
September 30, 2023
Study Completion (Actual)
December 4, 2023
Study Registration Dates
First Submitted
April 28, 2022
First Submitted That Met QC Criteria
May 4, 2022
First Posted (Actual)
May 10, 2022
Study Record Updates
Last Update Posted (Actual)
December 6, 2023
Last Update Submitted That Met QC Criteria
December 5, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2021-01-070
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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