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

Sponsor

University of Haifa (Other)

Overall Status

Completed

CT.gov ID

NCT05235243

Collaborator

(none)

697

Enrollment

Location

Arms

26.3

Actual Duration (Months)

26.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Internet-Based Intervention Psychological Intervention Intervention Study	Other: Online therapeutic intervention for maladaptive daydreaming based on mindfulness and self-monitoring Other: Online therapeutic intervention for maladaptive daydreaming based on mindfulness	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

697 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

An RCT in a double-blind setting comparing three groups across three measurement points in time (baseline, post-intervention, and 6-month follow-up)An RCT in a double-blind setting comparing three groups across three measurement points in time (baseline, post-intervention, and 6-month follow-up)

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 20, 2018

Actual Primary Completion Date :

Feb 3, 2020

Actual Study Completion Date :

Feb 28, 2021

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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

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.

Outcome Measures

Primary Outcome Measures

Change from baseline in maladaptive daydreaming [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.
Change from baseline in daydreaming frequency [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.
Change from baseline in work and social adjustment [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".

Secondary Outcome Measures

Change from baseline in psychiatric symptoms [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.
Change from baseline in intervention outcome [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.

Other Outcome Measures

Change from baseline mindful attention awareness [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.
The Feedback Questionnaire [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.
The Childhood Trauma Questionnaire [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Haifa	Haifa		Israel	3498838

Sponsors and Collaborators

University of Haifa

Investigators

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