AddictionPPJNCT04458181

Journaling and Addiction Recovery: Piloting "Positive Recovery Journaling"

A study testing Positive Peer Journaling (PPJ) in people with Addiction, run by University of Minnesota at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The main objective of this study is to pilot test the Positive Peer Journaling (PPJ) [later renamed "Positive Recovery Journaling" (PRJ)] intervention and its feasibility and acceptability. A second objective is to compare individuals assigned to PPJ to individuals in a treatment as usual control group. Read more about this study

Who is it for?: Ages 18 years and older
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: 81 participants
Where: 1 siteUnited States
Study dates: 7 Jul 2020to 1 Nov 2021
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
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

meet DSM-V criteria for past-year Substance Use Disorder 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 Nuway (approximately 2 weeks), an intensive outpatient substance use disorder treatment program and the recruitment site,
agree to be audio recorded or transcription recorded in group meetings and in individual meetings with research staff,
currently are clients in the Nuway outpatient 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,
participants must have an electronic device that connects to the internet and internet connection for online delivery of intervention during COVID-19.

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

NUWAY
Minneapolis, Minnesota, 55413

Other trials in United States

About this study

Read the detailed description

Many spiritual and religious traditions involve the practice of personal inventory and self-examination. These practices involve conducting a review of the day, spirituality, gratitude, and striving for self-knowledge and self-improvement. The 10th step of Alcoholics Anonymous (AA) recommends that members conduct such a daily inventory. While this practice may benefit AA members, not everyone seeking addiction recovery joins AA. Even for those who do, it can take time to reach step 10 and begin deriving benefits from it. The study PI, Dr. Amy Krentzman, developed Positive Recovery Journaling (PRJ, formerly "positive peer journaling") as a simple 10-minute daily practice which reviews the past 24 hours on the left side of a journal page and plans the upcoming 24 hours on the right side of a journal page. The prompts for the left and right sides of the PRJ page are based on principles from positive psychology and behavioral activation.

The main objective of this study is to pilot test the PRJ intervention and to examine the feasibility, acceptability, and logistics of treatment delivery.

A second objective is to observe whether PRJ is associated with improvement in satisfaction with life, happiness with recovery, and commitment to sobriety

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 subjective wellbeing in recovery and reduce relapse. PPJ uses 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. Good 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 groups in NCT04458181
Study group	Role	What they receive
Treatment Group	Experimental	Participants in this group will complete the intervention, Positive Peer Journaling (PPJ), while also continuing to attend intensive outpatient treatment for addiction. Receives: Behavioral: Positive Peer Journaling (PPJ)
Control Group	No intervention	There will be no intervention for those randomized to the control group. However, they will complete assessment instruments throughout the study period while also continuing to attend intensive outpatient treatment for addiction.

What is being measured

The primary outcome is the main question the study is designed to answer.

Satisfaction With Life at Baseline
Score on the "Satisfaction with Life" scale. This scale has 5 items assessed on a 7 point Likert-type response format. Scores range from 5 to 35 with higher scores representing higher satisfaction with life.
Measured: Baseline
Satisfaction With Life at 2 Weeks
Score on the "Satisfaction with Life" scale. This scale has 5 items assessed on a 7 point Likert-type response format. Scores range from 5 to 35 with higher scores representing higher satisfaction with life.
Measured: 2 weeks (after Phase 1, the group phase)
Satisfaction With Life at 4 Weeks
Score on the "Satisfaction with Life" scale. This scale has 5 items assessed on a 7 point Likert-type response format. Scores range from 5 to 35 with higher scores representing higher satisfaction with life.
Measured: 4 weeks (after Phase 2, the independent practice phase)
Satisfaction With Life at 8 Weeks
Score on the "Satisfaction with Life" scale. This scale has 5 items assessed on a 7 point Likert-type response format. Scores range from 5 to 35 with higher scores representing higher satisfaction with life.
Measured: 8 weeks (the 1-month post-intervention)
Happiness With Recovery at Baseline
Score on a single item, "In general, I am happy with my recovery." This item uses an 11 point scale ranging from 0 to 10. Higher scores represent higher happiness with recovery.
Measured: Baseline
Happiness With Recovery at 2 Weeks
Score on a single item, "In general, I am happy with my recovery." This item uses an 11 point scale ranging from 0 to 10. Higher scores represent higher happiness with recovery.
Measured: 2 weeks (after Phase 1, the group phase)
Happiness With Recovery at 4 Weeks
Score on a single item, "In general, I am happy with my recovery." This item uses an 11 point scale ranging from 0 to 10. Higher scores represent higher happiness with recovery.
Measured: 4 weeks (after Phase 2, the independent practice phase)
Happiness With Recovery at 8 Weeks
Score on a single item, "In general, I am happy with my recovery." This item uses an 11 point scale ranging from 0 to 10. Higher scores represent higher happiness with recovery.
Measured: 8 weeks (the 1-month post intervention)
Commitment to Sobriety at Baseline
Score on a single item, "I am willing to do whatever it takes to recover from my addiction." This item uses an 11 point scale ranging from 0-10. Higher scores represent greater commitment to sobriety.
Measured: Baseline
Commitment to Sobriety at 2 Weeks
Score on a single item, "I am willing to do whatever it takes to recover from my addiction." This item uses an 11 point scale ranging from 0-10. Higher scores represent greater commitment to sobriety.
Measured: 2 weeks (after Phase 1, the group phase)
Commitment to Sobriety at 4 Weeks
Score on a single item, "I am willing to do whatever it takes to recover from my addiction." This item uses an 11 point scale ranging from 0-10. Higher scores represent greater commitment to sobriety.
Measured: 4 weeks (after Phase 2, the independent practice phase)
Commitment to Sobriety at 8 Weeks
Score on a single item, "I am willing to do whatever it takes to recover from my addiction." This item uses an 11 point scale ranging from 0-10. Higher scores represent greater commitment to sobriety.
Measured: 8 weeks (the 1-month post intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Jul 20201 Nov 2021

First posted7 Jul 2020
Study start7 Jul 2020
Primary completion1 Nov 2021
Study completion1 Nov 2021

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.
More trials run by University of MinnesotaThe sponsor's other registered studies.
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
Masking: None (open label)
Enrolment: 81 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04458181
Sponsor's protocol ID: STUDY00004619-2
Acronym: PPJ
Status last verified: May 2024
First submitted: 21 May 2020
Last updated: 20 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Journaling and Addiction Recovery: Piloting "Positive Recovery Journaling"
ClinicalTrials.gov ID: NCT04458181
Acronym / sponsor ID: PPJ / STUDY00004619-2
Conditions: Addiction
Study type: Interventional
Recruitment status: Completed
Enrolment: 81 participants (actual)
Lead sponsor: University of MinnesotaUniversity, hospital or other
Study start: 7 Jul 2020 (actual)
Primary completion: 1 Nov 2021 (actual)
Study completion: 1 Nov 2021 (actual)
First posted: 7 Jul 2020 (actual)
Results: Posted 20 Jun 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The main objective of this study is to pilot test the PRJ intervention and to examine the feasibility, acceptability, and logistics of treatment delivery.

A second objective is to observe whether PRJ is associated with improvement in satisfaction with life, happiness with recovery, and commitment to sobriety

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Treatment Group	Experimental	Behavioral: Positive Peer Journaling (PPJ)Participants in this group will complete the intervention, Positive Peer Journaling (PPJ), while also continuing to attend intensive outpatient treatment for addiction.
Control Group	No intervention	–There will be no intervention for those randomized to the control group. However, they will complete assessment instruments throughout the study period while also continuing to attend intensive outpatient treatment for addiction.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

meet DSM-V criteria for past-year Substance Use Disorder 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 Nuway (approximately 2 weeks), an intensive outpatient substance use disorder treatment program and the recruitment site,
agree to be audio recorded or transcription recorded in group meetings and in individual meetings with research staff,

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 subjective wellbeing in recovery and reduce relapse. PPJ uses 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. Good 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

Satisfaction With Life at Baseline
Time frame: Baseline
Score on the "Satisfaction with Life" scale. This scale has 5 items assessed on a 7 point Likert-type response format. Scores range from 5 to 35 with higher scores representing higher satisfaction with life.
Satisfaction With Life at 2 Weeks
Time frame: 2 weeks (after Phase 1, the group phase)
Score on the "Satisfaction with Life" scale. This scale has 5 items assessed on a 7 point Likert-type response format. Scores range from 5 to 35 with higher scores representing higher satisfaction with life.
Satisfaction With Life at 4 Weeks
Time frame: 4 weeks (after Phase 2, the independent practice phase)
Score on the "Satisfaction with Life" scale. This scale has 5 items assessed on a 7 point Likert-type response format. Scores range from 5 to 35 with higher scores representing higher satisfaction with life.
Satisfaction With Life at 8 Weeks
Time frame: 8 weeks (the 1-month post-intervention)
Score on the "Satisfaction with Life" scale. This scale has 5 items assessed on a 7 point Likert-type response format. Scores range from 5 to 35 with higher scores representing higher satisfaction with life.
Happiness With Recovery at Baseline
Time frame: Baseline
Score on a single item, "In general, I am happy with my recovery." This item uses an 11 point scale ranging from 0 to 10. Higher scores represent higher happiness with recovery.
Happiness With Recovery at 2 Weeks
Time frame: 2 weeks (after Phase 1, the group phase)
Score on a single item, "In general, I am happy with my recovery." This item uses an 11 point scale ranging from 0 to 10. Higher scores represent higher happiness with recovery.
Happiness With Recovery at 4 Weeks
Time frame: 4 weeks (after Phase 2, the independent practice phase)
Score on a single item, "In general, I am happy with my recovery." This item uses an 11 point scale ranging from 0 to 10. Higher scores represent higher happiness with recovery.
Happiness With Recovery at 8 Weeks
Time frame: 8 weeks (the 1-month post intervention)
Score on a single item, "In general, I am happy with my recovery." This item uses an 11 point scale ranging from 0 to 10. Higher scores represent higher happiness with recovery.
Commitment to Sobriety at Baseline
Time frame: Baseline
Score on a single item, "I am willing to do whatever it takes to recover from my addiction." This item uses an 11 point scale ranging from 0-10. Higher scores represent greater commitment to sobriety.
Commitment to Sobriety at 2 Weeks
Time frame: 2 weeks (after Phase 1, the group phase)
Score on a single item, "I am willing to do whatever it takes to recover from my addiction." This item uses an 11 point scale ranging from 0-10. Higher scores represent greater commitment to sobriety.
Commitment to Sobriety at 4 Weeks
Time frame: 4 weeks (after Phase 2, the independent practice phase)
Score on a single item, "I am willing to do whatever it takes to recover from my addiction." This item uses an 11 point scale ranging from 0-10. Higher scores represent greater commitment to sobriety.
Commitment to Sobriety at 8 Weeks
Time frame: 8 weeks (the 1-month post intervention)
Score on a single item, "I am willing to do whatever it takes to recover from my addiction." This item uses an 11 point scale ranging from 0-10. Higher scores represent greater commitment to sobriety.

Results and safety

Results posted to the registry on 20 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Group	42	22
Control Group	39	28

Primary outcome: Satisfaction With Life at Baseline

Time frame: Baseline. Mean (Standard Deviation). Unit: units on a scale

Measure	Treatment Group n = 42	Control Group n = 39
Value	17.8 (6.6)	17.2 (6.4)

Primary outcome: Satisfaction With Life at 2 Weeks

Time frame: 2 weeks (after Phase 1, the group phase). Mean (Standard Deviation). Unit: units on a scale

Measure	Treatment Group n = 26	Control Group n = 35
Value	20.5 (6.8)	18.6 (7.8)

Population analysed: The "Overall Number of Participants Analyzed" reported here represents the study census for this outcome at 2 weeks. In the study flow section of this report, the values reported under "completed" represent the study census at 8 weeks. That is why the values reported here and the values reported in the study flow under "completed" do not match.

Primary outcome: Satisfaction With Life at 4 Weeks

Time frame: 4 weeks (after Phase 2, the independent practice phase). Mean (Standard Deviation). Unit: units on a scale

Measure	Treatment Group n = 24	Control Group n = 31
Value	19.4 (7.5)	18.8 (7.9)

Population analysed: The "Overall Number of Participants Analyzed" reported here represents the study census for this outcome at 4 weeks. In the study flow section of this report, the values reported under "completed" represent the study census at 8 weeks. That is why the values reported here and the values reported in the study flow under "completed" do not match.

Primary outcome: Satisfaction With Life at 8 Weeks

Time frame: 8 weeks (the 1-month post-intervention). Mean (Standard Deviation). Unit: units on a scale

Measure	Treatment Group n = 22	Control Group n = 28
Value	21 (7.4)	21.2 (7.9)

Population analysed: The "Overall Number of Participants Analyzed" reported here represents the study census for this outcome at 8 weeks. These values match the values reported as "completed" in the study flow section of this report.

Adverse events

Time frame: From baseline screening through 8 week assessment (approximately 8 weeks).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment Group	0 of 42 (0%)	0 of 42 (0%)	0 of 42
Control Group	0 of 39 (0%)	0 of 39 (0%)	0 of 39

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
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, MSW, PhD principal investigator

University of Minenesota

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 8 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 20 Jun 2024. 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 20 Jun 2024). 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?

Satisfaction With Life at Baseline (time frame: Baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04458181.

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 20 Jun 2024.