Constructive Self Assertiveness Via the Internet (R2)

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

Study Overview

• Status: Completed
• Conditions: Problems With Self-assertiveness
• Intervention / Treatment: Behavioral: Constructive self-assertiveness program via the internet

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 10691
    • Department of Psychology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Constructive self-assertiveness with guidance; 10 weeks of internet-based treatment with weekly assignments. The homework is commented on by the guide using electronic communication.	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.
Experimental: Constructive self-assertiveness without guidance; 10 weeks of internet-based treatment with weekly assignments. The homework is NOT commented on by any guide. Hence, same treatment as group 1 but without guidance.	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.
No Intervention: Waitlist control; No treatment, no guidance, just waiting for 10 weeks. After the ten weeks the participants will receive the treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Generalized Anxiety Disorder 7	General Anxiety questionnaire. Higher scores mean a worse outcome. Minimum and maximum values: 0-27.	Up to 12 months
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
Rathus Assertiveness Schedule	Assertiveness questionnaire. Higher scores mean a worse outcome. Minimum and maximum values: -30 to +30.	Up to 12 months
Well-being scale	Depression scale. Lower scores mean a worse outcome. Minimum and maximum values: 0-72.	Up to 12 months

Collaborators and Investigators

• Sponsor: Stockholm University

Publications and helpful links

General Publications

• 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. eCollection 2023 Apr.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): May 16, 2021
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: January 15, 2020
• First Submitted That Met QC Criteria: January 23, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: RESPECT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Analytic code and pseudoanonymous data in a data repository.
• IPD Sharing Supporting Information Type: ANALYTIC_CODE

Study Data/Documents

1. Individual Participant Data Set
2. Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No