Internet-Based InterventionNCT05235243
Can Mindfulness and Self-monitoring Improve Control Over Maladaptive Daydreaming?
A study testing Online therapeutic intervention for maladaptive daydreaming based on mindfulness and self-monitoring and Online therapeutic intervention for maladaptive daydreaming based on mindfulness in people with Internet-Based Intervention and Psychological Intervention, run by University of Haifa at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Internet-Based Intervention, Psychological Intervention, Intervention Study
- What is being tested?
- Online therapeutic intervention for maladaptive daydreaming based on mindfulness and self-monitoring and Online therapeutic intervention for maladaptive daydreaming based on mindfulness
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 697 participants
- Where
- 1 siteIsrael
- Study dates
- 20 Dec 2018to 28 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Online therapeutic intervention for maladaptive daydreaming based on mindfulness and self-monitoring, Online therapeutic intervention for maladaptive daydreaming based on mindfulness
- Keywords
- maladaptive daydreaming, immersive daydreaming, absorption, dissociation, behavioral addiction, compulsive behavior, RCT
- Medical subject headings
- Dissociative Disorders, Compulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online therapeutic intervention for maladaptive daydreaming based on mindfulness and self-monitoringOther
Also called Maladaptive daydreaming treatment program (MDTP)
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.
Online therapeutic intervention for maladaptive daydreaming based on mindfulnessOther
Also called Maladaptive daydreaming treatment program lite (MDTP)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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".
Measured: Baseline, post, and follow-up (8 month total)
Secondary outcomes (2)
Change from baseline in psychiatric symptoms
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.
Measured: Baseline, post, and follow-up (8 month total)
Change from baseline in intervention outcome
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.
Measured: Baseline, post, and follow-up (8 month total)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start20 Dec 2018
- Primary completion3 Feb 2020
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Internet-Based InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 697 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eli Somer, University of Haifa
- Investigators
- Oren Herscu, PhD, Study chair, School of Social Work, University of Haifa, IsraelEli Somer, PhD, Study director, School of Social Work, University of Haifa, IsraelNirit Soffer-Dudek, PhD, Principal investigator, Department of Psychology, Ben-Gurion University of the Negev, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05235243
- Sponsor's protocol ID
- 035/18
- Status last verified
- Feb 2022
- First submitted
- 19 Jan 2022
- Last updated
- 11 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Non
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05235243
- Acronym / sponsor ID
- 035/18
- Keywords
- maladaptive daydreaming, immersive daydreaming, absorption, dissociation, behavioral addiction, compulsive behavior, RCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 697 participants (actual)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- 3 Feb 2020 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 11 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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)
| Arm | Type | Receives |
|---|---|---|
| The Full Intervention (FI) group | Experimental | Other: Online therapeutic intervention for maladaptive daydreaming based on mindfulness and self-monitoringThe 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. |
| The partial intervention (PI) group | Active comparator | Other: Online therapeutic intervention for maladaptive daydreaming based on mindfulnessThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- Age under 18 years
- No MD diagnosis
- In concurrent psychology therapy for MD
- Not fluent in English
- Not having a daily internet access
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online therapeutic intervention for maladaptive daydreaming based on mindfulness and self-monitoringAlso: Maladaptive daydreaming treatment program (MDTP)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 | The Full Intervention (FI) group |
| Online therapeutic intervention for maladaptive daydreaming based on mindfulnessAlso: Maladaptive daydreaming treatment program lite (MDTP)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 | The partial intervention (PI) group |
Primary outcome
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.
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.
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".
2 secondary outcomes
Change from baseline in psychiatric symptoms
Time frame: Baseline, post, and follow-up (8 month total)
Change from baseline in intervention outcome
Time frame: Baseline, post, and follow-up (8 month total)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
- Individual participant dataSharing planned: No. Non
Related trials for Internet-Based Intervention
Recruiting
A Web-Based Dyadic Intervention for Colorectal Cancer
Colorectal Carcinoma
Not yet recruiting
Web-Based Sustainable Food Literacy Program for University Students
Food Literacy, Healthy Eating
Not yet recruiting
Feasibility of a Web-based Single-session Intervention Combined With Ecological Momentary Assessment and Intervention for Patients With Complex Posttraumatic Stress Disorder Awaiting Inpatient Treatment
PTSD - Post Traumatic Stress Disorder, Depression
Not yet recruiting
Hangeoreum: A Self-Paced Web-Based Program for Loneliness and Connectedness Among Korean Immigrants Aged 50 and Older
Loneliness, Korean
Recruiting
VOCALE LBD: Online Peer Support for Caregivers of People With Lewy Body Dementia
Lewy Bodies Disease, Depression Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oren Herscu, PhD study chair
School of Social Work, University of Haifa, Israel
Eli Somer, PhD study director
School of Social Work, University of Haifa, Israel
Nirit Soffer-Dudek, PhD principal investigator
Department of Psychology, Ben-Gurion University of the Negev, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online therapeutic intervention for maladaptive daydreaming based on mindfulness and self-monitoring and Online therapeutic intervention for maladaptive daydreaming based on mindfulness in people with Internet-Based Intervention and Psychological Intervention, run by University of Haifa at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in maladaptive daydreaming (time frame: Baseline, post, and follow-up (8 month total)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2022.