- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05560581
Digital Self-efficacy Training to Bridge Waiting Times for Psychotherapy
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Judith Rohde, MD
- Phone Number: +41 (0)58 384 65 00
- Email: judith.rohde@uzh.ch
Study Locations
-
-
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Winterthur, Switzerland
- Recruiting
- Integrated Psychiatry Winterthur
-
Contact:
- Jochen Binder
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Zurich, Switzerland
- Recruiting
- Psychiatric University Hospital
-
Contact:
- Judith Rohde
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
Participants will receive an one-week digital self-efficacy training (3x/day) and an one-week Ecological Momentary Assessment (3x/day questions on mood, social and virtual contacts).
|
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.
Participants will receive questions on mood and social/virtual contacts 3 times per day.
|
|
Active Comparator: Control group
Participants will receive an one-week Ecological Momentary Assessment (3x/day questions on mood, social and virtual contacts).
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Participants will receive questions on mood and social/virtual contacts 3 times per day.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in self-efficacy
Time Frame: baseline to 1 day after the intervention, 1 month after the intervention, within 1 month after the subsequent therapy began
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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.
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baseline to 1 day after the intervention, 1 month after the intervention, within 1 month after the subsequent therapy began
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in hopelessness
Time Frame: baseline to 1 day after the intervention, 1 month after the intervention, within 1 month after the subsequent therapy began
|
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
|
|
Change in anxiety
Time Frame: baseline to 1 day after the intervention, 1 month after the intervention, within 1 month after the subsequent therapy began
|
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
|
|
Change in stress
Time Frame: baseline to 1 day after the intervention, 1 month after the intervention, within 1 month after the subsequent therapy began
|
Stress will be assessed using the validated measure "Perceived Stress Scale" (10 items; higher scores indicate greater stress -> worse outcome).
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baseline to 1 day after the intervention, 1 month after the intervention, within 1 month after the subsequent therapy began
|
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Change in therapy expectations
Time Frame: baseline to 1 day after the intervention, 1 month after the intervention, within 1 month after the subsequent therapy began
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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).
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baseline to 1 day after the intervention, 1 month after the intervention, within 1 month after the subsequent therapy began
|
|
Change in depression
Time Frame: baseline to 1 day after the intervention, 1 month after the intervention, within 1 month after the subsequent therapy began
|
Depression will be assessed using the validated measure "Beck Depression Inventory II" (21 items; higher scores indicate greater depression -> worse outcome).
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baseline to 1 day after the intervention, 1 month after the intervention, within 1 month after the subsequent therapy began
|
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Change in optimism
Time Frame: baseline to 1 day after the intervention, 1 month after the intervention, within 1 month after the subsequent therapy began
|
Change in life orientation will be assessed using the validated measure "Life Orientation Test Revised" (10 items; higher scores indicate greater optimism -> better outcome)
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baseline to 1 day after the intervention, 1 month after the intervention, within 1 month after the subsequent therapy began
|
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Change in intolerance of uncertainty
Time Frame: baseline to 1 day after the intervention, 1 month after the intervention, within 1 month after the subsequent therapy began
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Intolerance of uncertainty will be assessed using the validated measure "Intolerance of uncertainty scale" (18 items; higher scores indicate greater uncertainty -> worse outcome).
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baseline to 1 day after the intervention, 1 month after the intervention, within 1 month after the subsequent therapy began
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in mood and contacts
Time Frame: 3 per day during one-week
|
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
|
|
Change in in ability to work
Time Frame: baseline to 1 month after the intervention, within 1 month after the subsequent therapy began
|
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)
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baseline to 1 month after the intervention, within 1 month after the subsequent therapy began
|
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Motivation and life enjoyment
Time Frame: baseline to 1 day after the intervention, 1 month after the intervention, within 1 month after the subsequent therapy began
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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"
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baseline to 1 day after the intervention, 1 month after the intervention, within 1 month after the subsequent therapy began
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Collaborators and Investigators
Investigators
- Principal Investigator: Judith Rohde, MD, Psychiatric University Hospital Zurich, University of Zurich
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SeApp III
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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