NCT05366998

Brief Summary

This study aims to inform scientific understanding of the impact of the therapeutic alliance and the transition from inpatient to outpatient care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 10, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2023

Completed
Last Updated

December 6, 2023

Status Verified

December 1, 2023

Enrollment Period

1.9 years

First QC Date

April 28, 2022

Last Update Submit

December 5, 2023

Conditions

Keywords

Therapeutic AllianceTreatment Outcome

Outcome Measures

Primary Outcomes (1)

  • Change from baseline psychological distress on Brief Symptom Checklist (BSCL, German version) at post-treatment and follow-up

    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 Outcomes (7)

  • Change from baseline quality of life on short version of the Incongruence Questionnaire (K-INK) at post-treatment and follow-up.

    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

    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)

    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)

    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)

    follow-up (after 2-4 months)

  • +2 more secondary outcomes

Other Outcomes (3)

  • Perceived experience of the transition from the inpatient to the outpatient setting at post-treatment on a qualitative item

    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)

    follow-up (after 2-4 months)

  • Additional demographics; previous inpatient settings and significant events after the clinic at follow-up on qualitative items

    follow-up (after 2-4 months)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • All patients admitted to in-patient treatment in the private psychiatric clinic Hohenegg (PKH) from November 2021 onwards

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Privatklinik Hohenegg

Meilen, Canton of Zurich, 8706, Switzerland

Location

Study Officials

  • Cosima A. Locher, Dr. phil.

    Privatklinik Hohenegg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
7 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. phil.

Study Record Dates

First Submitted

April 28, 2022

First Posted

May 10, 2022

Study Start

November 1, 2021

Primary Completion

September 30, 2023

Study Completion

December 4, 2023

Last Updated

December 6, 2023

Record last verified: 2023-12

Locations