Therapeutic AllianceNCT05366998
Therapeutic Alliance and Treatment Outcome
An observational study of Therapeutic Alliance, run by Privatklinik Hohenegg at 1 site in Switzerland.
Trial summary
This study aims to inform scientific understanding of the impact of the therapeutic alliance and the transition from inpatient to outpatient care. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Therapeutic Alliance
- How many people
- 102 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2021to 4 Dec 2023
- How long will I take part?
- 7 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- All patients admitted to in-patient treatment in the private psychiatric clinic Hohenegg (PKH) from November 2021 onwards
Who cannot join
- Due to the naturalistic approach of the study, there will be no selection or exclusion made
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Therapeutic Alliance
- Keywords
- Therapeutic Alliance, Treatment Outcome
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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".
Measured: 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
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.
Measured: 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)
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.
Measured: 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)
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".
Measured: 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)
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.
Measured: follow-up (after 2-4 months)
Perceived helpfulness of therapy for therapist effect at post-treatment on a single item
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".
Measured: 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)
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.
Measured: follow-up (after 2-4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start1 Nov 2021
- Primary completion30 Sep 2023
- Study completion4 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Therapeutic AllianceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 102 participants (actual)
- Target duration
- 7 Months
Sponsor and investigators
- Lead sponsor
- Privatklinik Hohenegg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cosima Locher, Privatklinik Hohenegg
- Investigators
- Cosima A. Locher, Dr. phil., Principal investigator, Privatklinik Hohenegg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05366998
- Sponsor's protocol ID
- 2021-01-070
- Status last verified
- Dec 2023
- First submitted
- 28 Apr 2022
- Last updated
- 6 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Alliance and Treatment Outcome: A Study of the Private Clinic Hohenegg
- ClinicalTrials.gov ID
- NCT05366998
- Acronym / sponsor ID
- 2021-01-070
- Conditions
- Therapeutic Alliance
- Keywords
- Therapeutic Alliance, Treatment Outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Privatklinik HoheneggUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 4 Dec 2023 (actual)
- First posted
- 10 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to inform scientific understanding of the impact of the therapeutic alliance and the transition from inpatient to outpatient care.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 7 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All patients admitted to in-patient treatment in the private psychiatric clinic Hohenegg (PKH) from November 2021 onwards
Key exclusion criteria (1 listed)
- Due to the naturalistic approach of the study, there will be no selection or exclusion made
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
7 secondary outcomes
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)
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)
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)
Perceived social support in inpatient setting at post-treatment on the Fellow Patient Social Support (FEPB)
Time frame: 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)
Perceived helpfulness of therapy for therapist effect at post-treatment on a single item
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cosima A. Locher, Dr. phil. principal investigator
Privatklinik Hohenegg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Therapeutic Alliance, run by Privatklinik Hohenegg at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.