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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05560581
Other study ID # SeApp III
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 7, 2022
Est. completion date October 2024

Study information

Verified date December 2022
Source Psychiatric University Hospital, Zurich
Contact Judith Rohde, MD
Phone +41 (0)58 384 65 00
Email judith.rohde@uzh.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main aim of this project is to improve waiting periods for specialised psychotherapy. We will apply a brief, smartphone-based self-efficacy training to patients with psychiatric disorders waiting for specialised psychotherapy. Additionally, we will use Ecological Momentary Assessment (EMA) to assess mood, social contacts, and other parameters daily. We will investigate whether the training can improve self-efficacy and related constructs and if it can help reduce stress and waitlist drop-outs during waiting periods. Additionally, we will investigate if the self-efficacy training has a positive effect on motivation and therapeutical relationship regarding the subsequent therapy. After a screening for eligibility, participants will be randomly assigned to intervention and control group. At baseline, participants attend a laboratory session where they are assessed for current psychiatric disorders and further relevant psychological variables. They will then either participate in the digital self-efficacy training combined with EMA (intervention group) or in EMA only (control group). Both will be conducted via a smartphone app. Subsequently, participants will be asked to fill in post questionnaires at three different time points: after having finished app usage, one month later, and after the beginning of the subsequent psychotherapy.


Recruitment information / eligibility

Status Recruiting
Enrollment 94
Est. completion date October 2024
Est. primary completion date April 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - psychiatric disorder - age 18-65 - waiting for psychiatric assessment/treatment (being on waitlist) - sufficient knowledge of the German language - smartphone user - internet access via smartphone - internet access at home (laptop, tablet, or computer) Exclusion Criteria: - current intense psychotherapy - acute suicidality - acute psychotic symptoms - substance addiction

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Digital self-efficacy training
Prior to the app participation, participants will receive psychoeducation on self-efficacy and will be instructed to define two autobiographical self-efficacy memories (own achievements, e.g., completion of an exam, success in a sporting event). During the week of app participation, they will be prompted three times per day and asked to perform an imagination task. Step by step, they will recall one of their autobiographic self-efficacy memories and focus on their character traits and abilities that were relevant for their achievement.
Ecological Momentary Assessment
Participants will receive questions on mood and social/virtual contacts 3 times per day.

Locations

Country Name City State
Switzerland Integrated Psychiatry Winterthur Winterthur
Switzerland Psychiatric University Hospital Zurich

Sponsors (1)

Lead Sponsor Collaborator
Psychiatric University Hospital, Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in mood and contacts pos. and neg. mood and contacts will be assessed with the Ecological Momentary Assessment. Higher pos. mood / lower neg. mood -> better outcome 3 per day during one-week
Other Change in in ability to work We will ask about the participants' self-evaluation at baseline and 2 different time points after the intervention (self-evaluation; no specific score will be used) baseline to 1 month after the intervention, within 1 month after the subsequent therapy began
Other Motivation and life enjoyment Additional questionnaire with single items assessing therapy motivation and life enjoyment with items based on the validated questionnaires "Quality of Life Enjoymend and Satisfaction Questionnaire", "Fragebogen zur Psychotherapiemotivation" und "Fragebogen zur Messung der Psychotherapiemotivation" baseline to 1 day after the intervention, 1 month after the intervention, within 1 month after the subsequent therapy began
Primary Change in self-efficacy Validated measures ("General Self-Efficacy Scale" (10 items; higher scores indicate higher self-efficacy -> better outcome), "Coping Self-efficacy scale" (26 items; higher scores indicate higher self-effiacy -> better outcome) and individual questions based on validated measures assessing specific self-efficacy regarding emotion regulation, therapy and waitlist will be used to assess self-efficacy at baseline and 3 different time points after the intervention. baseline to 1 day after the intervention, 1 month after the intervention, within 1 month after the subsequent therapy began
Secondary Change in hopelessness Hopelessness will be assessed using the validated measure "Beck Hopelessness Scale" (20 items; higher scores indicate greater hopelessness -> worse outcome). baseline to 1 day after the intervention, 1 month after the intervention, within 1 month after the subsequent therapy began
Secondary Change in anxiety Anxiety will be assessed using the validated measure "State and Trait Anxiety Scale" (40 items; higher scores indicate greater anxiety -> worse outcome). baseline to 1 day after the intervention, 1 month after the intervention, within 1 month after the subsequent therapy began
Secondary Change in stress Stress will be assessed using the validated measure "Perceived Stress Scale" (10 items; higher scores indicate greater stress -> worse outcome). baseline to 1 day after the intervention, 1 month after the intervention, within 1 month after the subsequent therapy began
Secondary Change in therapy expectations Therapy expectations will be assessed using the validated measure "Patient Questionnaire on Therapy Expectation and Evaluation" (11 items; higher score indicates higher satisfaction -> better outcome). baseline to 1 day after the intervention, 1 month after the intervention, within 1 month after the subsequent therapy began
Secondary Change in depression Depression will be assessed using the validated measure "Beck Depression Inventory II" (21 items; higher scores indicate greater depression -> worse outcome). baseline to 1 day after the intervention, 1 month after the intervention, within 1 month after the subsequent therapy began
Secondary Change in optimism Change in life orientation will be assessed using the validated measure "Life Orientation Test Revised" (10 items; higher scores indicate greater optimism -> better outcome) baseline to 1 day after the intervention, 1 month after the intervention, within 1 month after the subsequent therapy began
Secondary Change in intolerance of uncertainty Intolerance of uncertainty will be assessed using the validated measure "Intolerance of uncertainty scale" (18 items; higher scores indicate greater uncertainty -> worse outcome). baseline to 1 day after the intervention, 1 month after the intervention, within 1 month after the subsequent therapy began
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