AddictionPPJNCT03903159
Piloting "Positive Peer Journaling" a Journaling Practice to Support Recovery From Addiction
A study testing Positive Peer Journaling (PPJ) in people with Addiction, run by University of Minnesota at 1 site in United States.
Trial summary
The main objective of this study is development of the Positive Peer Journaling (PPJ) intervention and the feasibility, acceptability, and logistics of treatment delivery. A second objective is to observe whether PPJ is associated with improvement in hypothesized outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Addiction
- What is being tested?
- Positive Peer Journaling (PPJ)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2019to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- minimum 18 years of age,
- meet DSM-V criteria for past-year SUD as primary or secondary diagnosis,
- English literacy sufficient to make short written lists needed to complete PPJ and homework assessments,
- minimum 2 weeks sustained abstinence,
- completed first 2 weeks of treatment at Wayside (approximately 2 weeks), a residential substance use disorder treatment program and the recruitment site,
- priority will go to participants who are from or moving back to a rural area or small town defined as a population less than 10,500,
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- agree to be audio recorded in group meetings and in individual meetings with research staff,
- currently are clients in the Wayside residential program,
- participants must be English speaking and literacy must be strong enough to write short lists and to understand the questions asked in the questionnaires.
- Priority will go to women who will be residing at Wayside for the duration of the study activities (and not moving out after one week, for example).
Who cannot join
- presence of a psychotic disorder, psychiatric condition (e.g., suicidal ideation), or cognitive impairment (e.g., severe dementia, traumatic brain injury) limiting ability to give consent and/or participate in the study;
- severe psychiatric illness (current schizophrenia, major depression with suicidal ideation);
- personality disorders that would interfere with satisfactory participation in or completion of the study protocol,
- inability to give informed, voluntary consent to participate,
- lack of sufficient English literacy to participate, defined as inability to make a list of 5 things they did yesterday and inability to understand questionnaire items,
- any impairment, activity, or situation that in the judgement of the research staff would prevent satisfactory participation in or completion of the study protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wayside Women's Treatment Center
Saint Louis Park, Minnesota, 55416
About this study
Official title: Addiction Recovery in a Rural Minnesota Community: Piloting "Positive Peer Journaling" Part II
The main objective of this study is development of the Positive Peer Journaling (PPJ) intervention and the feasibility, acceptability, and logistics of treatment delivery. A second objective is to observe whether PPJ is associated with improvement in hypothesized outcomes. The primary outcomes the investigators will examine are enhanced treatment retention and reduced recurrence of substance use. The investigators will also explore the association between the intervention and a set of hypothesized mediators of the effect of the intervention on outcomes, e.g., improvement in mood and satisfaction with recovery.
- Conditions
- Addiction
- Being tested
- Positive Peer Journaling (PPJ)
- Medical subject headings
- Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Peer Journaling (PPJ)Behavioural
PPJ is a journaling practice to support addiction recovery. PPJ encourages past 24 hour review and upcoming 24 hour planning to improve quality of life in recovery and reduce relapse. PPJ uses standard lined journals with column headings under which individuals make bullet-pointed lists. On the left hand page, past 24 hours is recalled, itemizing "good" and "bad" things that happened and things for which one is grateful. Wishes for others are also expressed on this page. On the right hand page, values-based activities for the upcoming 24 hours are planned via headings representing valued life domains such as "recovery," "work/school," "spirituality," "home and household," and "health."
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Other | Positive Peer Journaling (PPJ) Receives: Behavioral: Positive Peer Journaling (PPJ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Retention
Percentage of participants who were retained in treatment at the host facility until the end of the study or who left the residential treatment facility on good terms during the course of the study.
Measured: 8 weeks
Substance Use
Evidence that the individual used drugs or alcohol during the intervention period. This will be assessed via positive drug screen (urine test or breathalizer) or participant self-report of substance use. Reported as the number of participants who use illicit substances during the study.
Measured: 8 weeks
Percentage of Group Sessions Attended
Percentage of group sessions will be calculated by taking the number of group sessions attended divided by total number of group sessions offered. Outcome is reported as the overall percentage of group attendance for all 15 participants combined.
Measured: 8 weeks
Number of PPJ Journal Entries Made
Total count of the number of PPJ journal entries made over the course of the study
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start29 Jan 2019
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AddictionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy Krentzman, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03903159
- Sponsor's protocol ID
- STUDY00004619
- Acronym
- PPJ
- Status last verified
- Aug 2021
- First submitted
- 18 Jan 2019
- Last updated
- 26 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addiction Recovery in a Rural Minnesota Community: Piloting "Positive Peer Journaling" Part II
- ClinicalTrials.gov ID
- NCT03903159
- Acronym / sponsor ID
- PPJ / STUDY00004619
- Conditions
- Addiction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 29 Jan 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 4 Apr 2019 (actual)
- Results
- Posted 26 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is development of the Positive Peer Journaling (PPJ) intervention and the feasibility, acceptability, and logistics of treatment delivery. A second objective is to observe whether PPJ is associated with improvement in hypothesized outcomes. The primary outcomes the investigators will examine are enhanced treatment retention and reduced recurrence of substance use. The investigators will also explore the association between the intervention and a set of hypothesized mediators of the effect of the intervention on outcomes, e.g., improvement in mood and satisfaction with recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Other | Behavioral: Positive Peer Journaling (PPJ)Positive Peer Journaling (PPJ) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- minimum 18 years of age,
- meet DSM-V criteria for past-year SUD as primary or secondary diagnosis,
- English literacy sufficient to make short written lists needed to complete PPJ and homework assessments,
- minimum 2 weeks sustained abstinence,
- completed first 2 weeks of treatment at Wayside (approximately 2 weeks), a residential substance use disorder treatment program and the recruitment site,
Key exclusion criteria (6 listed)
- presence of a psychotic disorder, psychiatric condition (e.g., suicidal ideation), or cognitive impairment (e.g., severe dementia, traumatic brain injury) limiting ability to give consent and/or participate in the study;
- severe psychiatric illness (current schizophrenia, major depression with suicidal ideation);
- personality disorders that would interfere with satisfactory participation in or completion of the study protocol,
- inability to give informed, voluntary consent to participate,
- lack of sufficient English literacy to participate, defined as inability to make a list of 5 things they did yesterday and inability to understand questionnaire items,
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 |
|---|---|---|
| Positive Peer Journaling (PPJ)PPJ is a journaling practice to support addiction recovery. PPJ encourages past 24 hour review and upcoming 24 hour planning to improve quality of life in recovery and reduce relapse. PPJ uses standard lined journals with column headings under which individuals make bullet-pointed lists. On the left hand page, past 24 hours is recalled, itemizing "good" and "bad" things that happened and things for which one is grateful. Wishes for others are also expressed on this page. On the right hand page, values-based activities for the upcoming 24 hours are planned via headings representing valued life domains such as "recovery," "work/school," "spirituality," "home and household," and "health." | Behavioural | Treatment Group |
Primary outcome
Treatment Retention
Time frame: 8 weeks
Percentage of participants who were retained in treatment at the host facility until the end of the study or who left the residential treatment facility on good terms during the course of the study.
Substance Use
Time frame: 8 weeks
Evidence that the individual used drugs or alcohol during the intervention period. This will be assessed via positive drug screen (urine test or breathalizer) or participant self-report of substance use. Reported as the number of participants who use illicit substances during the study.
Percentage of Group Sessions Attended
Time frame: 8 weeks
Percentage of group sessions will be calculated by taking the number of group sessions attended divided by total number of group sessions offered. Outcome is reported as the overall percentage of group attendance for all 15 participants combined.
Number of PPJ Journal Entries Made
Time frame: 8 weeks
Total count of the number of PPJ journal entries made over the course of the study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Amy Krentzman principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Peer Journaling (PPJ) in people with Addiction, run by University of Minnesota at 1 site in United States.
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 10 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 26 Aug 2021. 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 United States. 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?
Yes. Results are posted in the registry (first posted 26 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Treatment Retention (time frame: 8 weeks). The study lists 4 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 26 Aug 2021.