NCT05560581

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 29, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

November 7, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

March 4, 2025

Status Verified

November 1, 2024

Enrollment Period

3 years

First QC Date

September 25, 2022

Last Update Submit

February 27, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Change in hopelessness

    baseline to 1 day after the intervention, 1 month after the intervention, within 1 month after the subsequent therapy began

  • Change in anxiety

    baseline to 1 day after the intervention, 1 month after the intervention, within 1 month after the subsequent therapy began

  • Change in stress

    baseline to 1 day after the intervention, 1 month after the intervention, within 1 month after the subsequent therapy began

  • Change in therapy expectations

    baseline to 1 day after the intervention, 1 month after the intervention, within 1 month after the subsequent therapy began

  • Change in depression

    baseline to 1 day after the intervention, 1 month after the intervention, within 1 month after the subsequent therapy began

  • +2 more secondary outcomes

Other Outcomes (3)

  • Change in mood and contacts

    3 per day during one-week

  • Change in in ability to work

    baseline to 1 month after the intervention, within 1 month after the subsequent therapy began

  • Motivation and life enjoyment

    baseline to 1 day after the intervention, 1 month after the intervention, within 1 month after the subsequent therapy began

Study Arms (2)

Intervention group

EXPERIMENTAL

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 trainingBehavioral: Ecological Momentary Assessment

Control group

ACTIVE COMPARATOR

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

Behavioral: Ecological Momentary Assessment

Interventions

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 group

Participants will receive questions on mood and social/virtual contacts 3 times per day.

Control groupIntervention group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • current intense psychotherapy
  • acute suicidality
  • acute psychotic symptoms
  • substance addiction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Integrated Psychiatry Winterthur

Winterthur, Switzerland

RECRUITING

Psychiatric University Hospital

Zurich, Switzerland

RECRUITING

MeSH Terms

Conditions

Mental Disorders

Interventions

Ecological Momentary Assessment

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Officials

  • Judith Rohde, MD

    Psychiatric University Hospital Zurich, University of Zurich

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
double-blind
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinician Scientist

Study Record Dates

First Submitted

September 25, 2022

First Posted

September 29, 2022

Study Start

November 7, 2022

Primary Completion

November 1, 2025

Study Completion

November 1, 2025

Last Updated

March 4, 2025

Record last verified: 2024-11

Locations