Digital Self-efficacy Training to Bridge Waiting Times for Psychotherapy

Sponsor
Psychiatric University Hospital, Zurich (Other)
Overall Status
Recruiting
CT.gov ID
NCT05560581
Collaborator
(none)
94
2
2
22.8
47
2.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Digital self-efficacy training
  • Behavioral: Ecological Momentary Assessment
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
94 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
double-blind
Primary Purpose:
Health Services Research
Official Title:
Digital Self-efficacy Training to Bridge Waiting Times for Psychotherapy
Actual Study Start Date :
Nov 7, 2022
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

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).

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.

Behavioral: Ecological Momentary Assessment
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).

Behavioral: Ecological Momentary Assessment
Participants will receive questions on mood and social/virtual contacts 3 times per day.

Outcome Measures

Primary Outcome Measures

  1. Change in self-efficacy [baseline to 1 day after the intervention, 1 month after the intervention, within 1 month after the subsequent therapy began]

    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

  1. Change in hopelessness [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).

  2. Change in anxiety [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).

  3. Change in stress [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).

  4. Change in therapy expectations [baseline to 1 day after the intervention, 1 month after the intervention, within 1 month after the subsequent therapy began]

    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).

  5. Change in depression [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).

  6. Change in optimism [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)

  7. Change in intolerance of uncertainty [baseline to 1 day after the intervention, 1 month after the intervention, within 1 month after the subsequent therapy began]

    Intolerance of uncertainty will be assessed using the validated measure "Intolerance of uncertainty scale" (18 items; higher scores indicate greater uncertainty -> worse outcome).

Other Outcome Measures

  1. Change in mood and contacts [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

  2. Change in in ability to work [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)

  3. Motivation and life enjoyment [baseline to 1 day after the intervention, 1 month after the intervention, within 1 month after the subsequent therapy began]

    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"

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Integrated Psychiatry Winterthur Winterthur Switzerland
2 Psychiatric University Hospital Zurich Switzerland

Sponsors and Collaborators

  • Psychiatric University Hospital, Zurich

Investigators

  • Principal Investigator: Judith Rohde, MD, Psychiatric University Hospital Zurich, University of Zurich

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Judith Rohde, MD, Clinician Scientist, Psychiatric University Hospital, Zurich
ClinicalTrials.gov Identifier:
NCT05560581
Other Study ID Numbers:
  • SeApp III
First Posted:
Sep 29, 2022
Last Update Posted:
Dec 7, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 7, 2022