Digital Self-efficacy Training to Bridge Waiting Times for Psychotherapy

Psychiatric Disorder Clinical Trial

Official title:

Digital Self-efficacy Training to Bridge Waiting Times for Psychotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05560581
• Other study ID #: SeApp III
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Mental Disorders
• Problem Behavior
• Psychiatric Disorder

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