NCT05235243

Brief Summary

Maladaptive daydreaming (MD) is a compulsive form of daydreaming that causes distress and functional impairment among tens of thousands of self-diagnosed sufferers. This is the first controlled treatment trial for MD. The investigators built an internet-based self-help program for MD and tested the effectiveness of mindfulness and self-monitoring in improving control over MD, comparing three groups across three measurement points in time.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
697

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 20, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2020

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 11, 2022

Completed
Last Updated

February 11, 2022

Status Verified

February 1, 2022

Enrollment Period

1.1 years

First QC Date

January 19, 2022

Last Update Submit

February 9, 2022

Conditions

Keywords

maladaptive daydreamingimmersive daydreamingabsorptiondissociationbehavioral addictioncompulsive behaviorRCT

Outcome Measures

Primary Outcomes (3)

  • Change from baseline in maladaptive daydreaming

    Change in the 16-item Maladaptive Daydreaming Scale (MDS-16) compared to baseline, measured 2 months and 6 months post-intervention. The MDS-16 is the primary self-report scale that gauges maladaptive daydreaming on a 10-point Likert scale. Scores range from 0 to 100, with the mean score of 40 set as an evidence-based cut-off score for clinical-level MD. Higher scores indicate an elevated level of maladaptive daydreaming, hence, a worse outcome.

    Baseline, post, and follow-up (8 month total)

  • Change from baseline in daydreaming frequency

    Change in the Daydreaming Frequency Scale (DDFS) compared to baseline, measured 2 months and 6 months post-intervention. The DDFS is a 12-item subscale of the Imaginal Processes Inventory, gauging reported daydreaming frequency. Items are marked on a 5-point Likert scale. Scores range from 12 to 60. Higher scores indicate an elevated frequency of daydreaming, hence, a worse outcome.

    Baseline, post, and follow-up (8 month total)

  • Change from baseline in work and social adjustment

    Change in the Daydreaming Work and Social Adjustment Scale (DWSAS) compared to baseline, measured 2 months and 6 months post-intervention. The DWSAS is a 6-item measure assessing adjustment and disfunction in relation to daydreaming. Items are ranked on a 9-point Likert scale ranging from 0 to 8. The DWSAS scores range from 0 to 48. A score of 12 or lower indicates "no pathology and disfunction". Scores between 12 and 24 indicate "pathology and impaired function", while scores of 24 or above suggest "severe pathology and impaired function".

    Baseline, post, and follow-up (8 month total)

Secondary Outcomes (2)

  • Change from baseline in psychiatric symptoms

    Baseline, post, and follow-up (8 month total)

  • Change from baseline in intervention outcome

    Baseline, post, and follow-up (8 month total)

Other Outcomes (3)

  • Change from baseline mindful attention awareness

    Baseline, post, and follow-up (8 month total)

  • The Feedback Questionnaire

    Post-intervention, and follow-up (6 month total)

  • The Childhood Trauma Questionnaire

    Baseline (1 day)

Study Arms (3)

The Full Intervention (FI) group

EXPERIMENTAL

The full intervention (FI) group received a psycho-education module about MD and its addictive behavior mechanism, a motivation enhancement module based on motivational interviewing, mindfulness modules, and self-monitoring modules.

Other: Online therapeutic intervention for maladaptive daydreaming based on mindfulness and self-monitoring

The partial intervention (PI) group

ACTIVE COMPARATOR

The partial intervention (PI) group received an intervention identical to the FI group (a psycho-education module about MD and its addictive behavior mechanism, a motivation enhancement module based on motivational interviewing, mindfulness modules) with the exclusion of the self-monitoring modules.

Other: Online therapeutic intervention for maladaptive daydreaming based on mindfulness

Waiting List (WL) group

NO INTERVENTION

Waiting List (WL) group did not undergo any intervention during the study period. However, WL participants were told that the program will commence in three months. During their waiting time participants were instructed to reduce their daydreaming activity to the best of their ability. Since all participants were recruited for this study from an online support forum (that is not part of this research design), the investigators labeled WL as the Internet Support as Usual (ISAU) group.

Interventions

An 8-weeks internet-based self-guided intervention program, accompanied by e-mail. The content of the intervention and training modules comprised texts, illustrations, explanatory video and audio lectures, as well as interactive worksheets embedded in each week's lesson. Typically, a lesson started with a textual description of its target and duration. Then, participants received a summary of what had been taught thus far, and finally, a novel technique or skill was introduced. Each lesson required about 60 minutes to complete. Users had open access to web pages of previous lessons. Upon completion of each lesson, participants received a list of home assignments to practice during the following week. Our internet-based program featured a notification and download center containing the program's materials and pertinent messages from the researchers.

Also known as: Maladaptive daydreaming treatment program (MDTP)
The Full Intervention (FI) group

An 8-weeks internet-based self-guided intervention program, accompanied by e-mail. The content of the intervention and training modules comprised texts, illustrations, explanatory video and audio lectures, as well as interactive worksheets embedded in each week's lesson. Typically, a lesson started with a textual description of its target and duration. Then, participants received a summary of what had been taught thus far, and finally, a novel technique or skill was introduced. Each lesson required about 60 minutes to complete. Users had open access to web pages of previous lessons. Upon completion of each lesson, participants received a list of home assignments to practice during the following week. Our internet-based program featured a notification and download center containing the program's materials and pertinent messages from the researchers.

Also known as: Maladaptive daydreaming treatment program lite (MDTP)
The partial intervention (PI) group

Eligibility Criteria

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

You may qualify if:

  • Age above 18 years
  • MD diagnosis
  • Not being in any concurrent treatment for MD
  • English fluent
  • Daily access to the internet, and to a device with internet access
  • Give informed consent to the study
  • Respondents who reported being on a stable dose of medication for at least three months could take part in the study provided that they did not change their dosages while participating in the study.

You may not qualify if:

  • Age under 18 years
  • No MD diagnosis
  • In concurrent psychology therapy for MD
  • Not fluent in English
  • Not having a daily internet access
  • Taking medication for less than three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Haifa

Haifa, 3498838, Israel

Location

MeSH Terms

Conditions

Dissociative DisordersCompulsive Behavior

Condition Hierarchy (Ancestors)

Mental DisordersImpulsive BehaviorBehavior

Study Officials

  • Oren Herscu, PhD

    School of Social Work, University of Haifa, Israel

    STUDY CHAIR
  • Eli Somer, PhD

    School of Social Work, University of Haifa, Israel

    STUDY DIRECTOR
  • Nirit Soffer-Dudek, PhD

    Department of Psychology, Ben-Gurion University of the Negev, Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: An RCT in a double-blind setting comparing three groups across three measurement points in time (baseline, post-intervention, and 6-month follow-up)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Eli Somer

Study Record Dates

First Submitted

January 19, 2022

First Posted

February 11, 2022

Study Start

December 20, 2018

Primary Completion

February 3, 2020

Study Completion

February 28, 2021

Last Updated

February 11, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Non

Locations