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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Switzerland
    • Zürich
      • Meilen, Zürich, Switzerland, 8706
        • Privatklinik Hohenegg

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
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".
Post-treatment (after 6-8 weeks)
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)
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.
follow-up (after 2-4 months)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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)
A qualitative item about fears related to the transition to outpatient treatment.
Post-treatment (after 6-8 weeks)
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)

14 qualitative items about

  • the transition to outpatient treatment
  • the influence of the PKH
  • maintaining contact to other patients
  • acquired skills from the inpatient treatment at PKH
  • improvements of the transition from inpatient to outpatient treatment
  • social support during the transition to outpatient treatment
follow-up (after 2-4 months)
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)
Two qualitative items, one about previous inpatient treatment experiences and the other about significant events after the treatment in the PKH.
follow-up (after 2-4 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Privatklinik Hohenegg

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 4, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 10, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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