Can Mindfulness and Self-monitoring Improve Control Over Maladaptive Daydreaming?

February 9, 2022 updated by: Eli Somer, University of Haifa

Can Mindfulness Meditation and Self-monitoring Can Help Improve Control Over Maladaptive Daydreaming: A Randomized Controlled Trial of a Self-guided Web-based Program

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Objective: 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. Method: 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, compared to internet-based support as usual (waiting-list group). Participants were randomly assigned to three groups and measured across three points in time (baseline, post-intervention, and 6 months follow-up). The investigators measured the change in daydreaming pathology (MDS-16), daydreaming frequency (DDFS), and daydreaming functioning (DWSAS), alongside changes in psychiatric symptoms (BSI), and intervention outcome (OQ). Changes in mindful attention and awareness skills, compliance with program requirements, and feedback to the program were also measured.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
697

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel, 3498838
        • University of Haifa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: The Full Intervention (FI) group
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
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.
Other Names:
  • Maladaptive daydreaming treatment program (MDTP)
Active Comparator: The partial intervention (PI) group
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
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.
Other Names:
  • Maladaptive daydreaming treatment program lite (MDTP)
No Intervention: Waiting List (WL) group
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline in maladaptive daydreaming
Time Frame: Baseline, post, and follow-up (8 month total)
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
Time Frame: Baseline, post, and follow-up (8 month total)
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
Time Frame: Baseline, post, and follow-up (8 month total)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in psychiatric symptoms
Time Frame: Baseline, post, and follow-up (8 month total)
Change in the Brief Symptom Inventory (BSI) compared to baseline, measured 2 months and 6 months post-intervention. The BSI is a 53-item scale rated on a 5-point Likert scale of general psychopathology. The BSI is divided into nine subscales: somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, and four additional items. The BSI total score ranges from 0 to 4. Higher scores suggest elevated psychopathology, hence, a worse outcome.
Baseline, post, and follow-up (8 month total)
Change from baseline in intervention outcome
Time Frame: Baseline, post, and follow-up (8 month total)
Change in the Outcome Questionnaire (OQ) from baseline, measured 2 months and 6 months post-intervention. The OQ is a 45-item scale evaluating the quality of mental health care and its outcome featuring three sub-scales: subjective discomfort, interpersonal relations, and social role performance. The OQ scores range from 0 to 180. Higher scores indicate a worse outcome.
Baseline, post, and follow-up (8 month total)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline mindful attention awareness
Time Frame: Baseline, post, and follow-up (8 month total)
Change in the Mindful Attention Awareness Scale (MAAS) from baseline, measured 2 months and 6 months post-intervention. The MAAS assesses awareness and mindful attention and is a common measure in psychological studies of mindfulness training. It gauges the extent to which participants acquired the target mindfulness skill. This is a 15-item, 6-point Likert scale with scores ranging from 15 to 90. Higher scores suggest a higher level of acquired the target mindfulness skills, hence, a better outcome.
Baseline, post, and follow-up (8 month total)
The Feedback Questionnaire
Time Frame: Post-intervention, and follow-up (6 month total)
The Feedback Questionnaire (FBQ) measures the participants' satisfaction with the program and its contents. The FBQ was administered twice: as an immediate post-intervention assessment and, at a 6-month follow-up. The FBQ contains 21 items: 17 of which were ranked on a 5-point Likert scale, and 4 items were optional open questions. This outcome ranked from 1 to 5. Higher scores present more positive feedback to the treatment program, hence, a better outcome.
Post-intervention, and follow-up (6 month total)
The Childhood Trauma Questionnaire
Time Frame: Baseline (1 day)
The Childhood Trauma Questionnaire (CTQ) is a 28-item scale rated on a 5-point Likert scale. The CTQ has five subscales containing five items each: emotional abuse, physical abuse, sexual abuse, emotional neglect, and physical neglect. Each subscale is rated between 5 to 25. The total CTQ scale scores range from 25 to 125. Higher scores represent more childhood trauma, hence, a worse outcome.
Baseline (1 day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Haifa

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Oren Herscu, PhD, School of Social Work, University of Haifa, Israel
  • Study Director: Eli Somer, PhD, School of Social Work, University of Haifa, Israel
  • Principal Investigator: Nirit Soffer-Dudek, PhD, Department of Psychology, Ben-Gurion University of the Negev, Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 20, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 3, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 19, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 11, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 11, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 035/18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Non

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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