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Digital Self-efficacy Training to Bridge Waiting Times for Psychotherapy

Primary Purpose

Psychiatric Disorder, Waiting for Psychotherapy

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Digital self-efficacy training
Ecological Momentary Assessment
Sponsored by
Psychiatric University Hospital, Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Psychiatric Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Integrated Psychiatry WinterthurRecruiting
  • Psychiatric University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group

Control group

Arm Description

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).

Participants will receive an one-week Ecological Momentary Assessment (3x/day questions on mood, social and virtual contacts).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in hopelessness
Hopelessness will be assessed using the validated measure "Beck Hopelessness Scale" (20 items; higher scores indicate greater hopelessness -> worse outcome).
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).
Change in stress
Stress will be assessed using the validated measure "Perceived Stress Scale" (10 items; higher scores indicate greater stress -> worse outcome).
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).
Change in depression
Depression will be assessed using the validated measure "Beck Depression Inventory II" (21 items; higher scores indicate greater depression -> worse outcome).
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)
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).

Full Information

First Posted
September 25, 2022
Last Updated
December 3, 2022
Sponsor
Psychiatric University Hospital, Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT05560581
Brief Title
Digital Self-efficacy Training to Bridge Waiting Times for Psychotherapy
Official Title
Digital Self-efficacy Training to Bridge Waiting Times for Psychotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 7, 2022 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Psychiatric University Hospital, Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychiatric Disorder, Waiting for Psychotherapy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
double-blind
Allocation
Randomized
Enrollment
94 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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).
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Participants will receive an one-week Ecological Momentary Assessment (3x/day questions on mood, social and virtual contacts).
Intervention Type
Behavioral
Intervention Name(s)
Digital self-efficacy training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Ecological Momentary Assessment
Intervention Description
Participants will receive questions on mood and social/virtual contacts 3 times per day.
Primary Outcome Measure Information:
Title
Change in self-efficacy
Description
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.
Time Frame
baseline to 1 day after the intervention, 1 month after the intervention, within 1 month after the subsequent therapy began
Secondary Outcome Measure Information:
Title
Change in hopelessness
Description
Hopelessness will be assessed using the validated measure "Beck Hopelessness Scale" (20 items; higher scores indicate greater hopelessness -> worse outcome).
Time Frame
baseline to 1 day after the intervention, 1 month after the intervention, within 1 month after the subsequent therapy began
Title
Change in anxiety
Description
Anxiety will be assessed using the validated measure "State and Trait Anxiety Scale" (40 items; higher scores indicate greater anxiety -> worse outcome).
Time Frame
baseline to 1 day after the intervention, 1 month after the intervention, within 1 month after the subsequent therapy began
Title
Change in stress
Description
Stress will be assessed using the validated measure "Perceived Stress Scale" (10 items; higher scores indicate greater stress -> worse outcome).
Time Frame
baseline to 1 day after the intervention, 1 month after the intervention, within 1 month after the subsequent therapy began
Title
Change in therapy expectations
Description
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).
Time Frame
baseline to 1 day after the intervention, 1 month after the intervention, within 1 month after the subsequent therapy began
Title
Change in depression
Description
Depression will be assessed using the validated measure "Beck Depression Inventory II" (21 items; higher scores indicate greater depression -> worse outcome).
Time Frame
baseline to 1 day after the intervention, 1 month after the intervention, within 1 month after the subsequent therapy began
Title
Change in optimism
Description
Change in life orientation will be assessed using the validated measure "Life Orientation Test Revised" (10 items; higher scores indicate greater optimism -> better outcome)
Time Frame
baseline to 1 day after the intervention, 1 month after the intervention, within 1 month after the subsequent therapy began
Title
Change in intolerance of uncertainty
Description
Intolerance of uncertainty will be assessed using the validated measure "Intolerance of uncertainty scale" (18 items; higher scores indicate greater uncertainty -> worse outcome).
Time Frame
baseline to 1 day after the intervention, 1 month after the intervention, within 1 month after the subsequent therapy began
Other Pre-specified Outcome Measures:
Title
Change in mood and contacts
Description
pos. and neg. mood and contacts will be assessed with the Ecological Momentary Assessment. Higher pos. mood / lower neg. mood -> better outcome
Time Frame
3 per day during one-week
Title
Change in in ability to work
Description
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)
Time Frame
baseline to 1 month after the intervention, within 1 month after the subsequent therapy began
Title
Motivation and life enjoyment
Description
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"
Time Frame
baseline to 1 day after the intervention, 1 month after the intervention, within 1 month after the subsequent therapy began

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Judith Rohde, MD
Phone
+41 (0)58 384 65 00
Email
judith.rohde@uzh.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith Rohde, MD
Organizational Affiliation
Psychiatric University Hospital Zurich, University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Integrated Psychiatry Winterthur
City
Winterthur
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jochen Binder
Facility Name
Psychiatric University Hospital
City
Zurich
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Judith Rohde

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Digital Self-efficacy Training to Bridge Waiting Times for Psychotherapy

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