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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04240249
Other study ID # Respect
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2020
Est. completion date December 31, 2022

Study information

Verified date April 2024
Source Stockholm University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Some people have problems with self-assertiveness. That can have negative impact on their lives. This study will test a constructive self-assertiveness intervention program delivered online. In addition, the relative effect of guidance during the intervention will be investigated. In a randomized controlled trial three groups will be compared: 1. constructive self-assertiveness with guidance 2. constructive self-assertiveness without guidance 3. Waitlist control


Description:

Some people have problems with self-assertiveness. That can have negative impact on their lives. This study will test a constructive self-assertiveness intervention program delivered online. In addition, the relative effect of guidance during the intervention will be investigated. In a randomized controlled trial three groups will be compared: 1. constructive self-assertiveness with guidance 2. constructive self-assertiveness without guidance 3. Waitlist control The treatment (and wait) will be 10 weeks.


Recruitment information / eligibility

Status Completed
Enrollment 210
Est. completion date December 31, 2022
Est. primary completion date May 16, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Human, - At least 18 years old, - Able to speak and read Swedish, - Informed consent. Exclusion Criteria: - Severe depression (as defined by a PHQ9 score of 15 points or higher), - If on medication the dosage has been stable for at least the past 3 months, - No ongoing psychotherapy.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Constructive self-assertiveness program via the internet
Participants will get one "chapter" a week to work with. All chapters are presented on web pages and include information and exercises and end with homework assignments.

Locations

Country Name City State
Sweden Department of Psychology Stockholm

Sponsors (1)

Lead Sponsor Collaborator
Stockholm University

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Hagberg T, Manhem P, Oscarsson M, Michel F, Andersson G, Carlbring P. Efficacy of transdiagnostic cognitive-behavioral therapy for assertiveness: A randomized controlled trial. Internet Interv. 2023 May 13;32:100629. doi: 10.1016/j.invent.2023.100629. eCo — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Adaptive and Aggressive Assertiveness Scale A self-report questionnaire measuring Adaptive and Aggressive Assertiveness. Higher scores mean a worse outcome. Minimum and maximum values: 30-150. Up to 12 months
Secondary Patient Health Questionnaire 9-item Depression questionnaire. Higher scores mean a worse outcome. Higher scores mean a worse outcome. Minimum and maximum values: 0-27. Up to 12 months
Secondary Generalized Anxiety Disorder 7 General Anxiety questionnaire. Higher scores mean a worse outcome. Minimum and maximum values: 0-27. Up to 12 months
Secondary Liebowitz Social Anxiety Scale , self-report Social Anxiety questionnaire. Higher scores mean a worse outcome. Minimum and maximum values: 0-144. Up to 12 months
Secondary Rathus Assertiveness Schedule Assertiveness questionnaire. Higher scores mean a worse outcome. Minimum and maximum values: -30 to +30. Up to 12 months
Secondary Well-being scale Depression scale. Lower scores mean a worse outcome. Minimum and maximum values: 0-72. Up to 12 months