Psoriasis (PsO)RePSONCT05894759
Online Therapist-guided Receptive Music Therapy in Adults With Psoriasis
A study testing Therapist-guided receptive music therapy in people with Psoriasis (PsO) and Psychological Distress, run by Grigore T. Popa University of Medicine and Pharmacy at 1 site in Romania.
Trial summary
This single-center, three-arm randomized controlled trial evaluated a four-week online therapist-guided receptive music therapy program as an adjunct to treatment as usual in adults with moderate-to-severe psoriasis and clinically relevant psychological or quality-of-life burden. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis (PsO), Psychological Distress, Depressive Symptom
- What is being tested?
- Therapist-guided receptive music therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteRomania
- Study dates
- 15 Jun 2023to 5 Aug 2025
- Phase
- Interventional
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 18 years or older.
- Clinical diagnosis of moderate-to-severe psoriasis. Moderate disease was operationalized as PASI 5-10 and severe disease as PASI greater than 10; clinically severe involvement of high-impact or difficult-to-treat sites could also establish eligibility when global PASI underestimated localized burden.
- Psychological stress identified from clinical history as a trigger or aggravating factor for psoriasis and perceived-stress VAS score of at least 3.
- At least one of the following: DLQI at least 6, PHQ-9 at least 5, or GAD-7 at least 5.
- Access to a computer, laptop, or smartphone with an internet connection.
- Ability to understand the study procedures and provide written informed consent.
Who cannot join
- Another dermatological disorder with an independent effect on quality of life.
- A clear psychiatric disorder or current psychiatric treatment.
- Positive response to PHQ-9 item 9, PHQ-9 functional-impact rating of 3, PHQ-9 score at least 20, or GAD-7 score at least 15.
- Major hearing impairment preventing participation in the audio interventions.
- Current or planned participation in another clinical study that could overlap with RePSO.
- Pregnancy.
- Inability to read the study material or complete the questionnaires.
Trial locations and contacts
1 site in 1 country.
Romania1 site
Grigore T. Popa University of Medicine and Pharmacy Iasi
Iași, Iaşi, 700137
About this study
Official title: Effects of Adjunctive Online Therapist-guided Receptive Music Therapy on Quality of Life and Psychological Outcomes in Adults With Psoriasis: a Three-arm Randomized Controlled Trial
This single-center, three-arm randomized controlled trial evaluated a four-week online therapist-guided receptive music therapy program as an adjunct to treatment as usual in adults with moderate-to-severe psoriasis and clinically relevant psychological or quality-of-life burden. Seventy-five participants were randomized in a 1:1:1 ratio to treatment as usual, treatment as usual plus an audio-based active relaxation control, or treatment as usual plus therapist-guided receptive music therapy.
The principal comparison was between the music therapy and active control groups. Dermatology-specific quality of life, perceived psychological stress, anxiety, and depressive symptoms were assessed at baseline, at the end of the four-week intervention, and at three and six months after the intervention.
Dermatological severity, treatment adherence, intervention adherence, and other prespecified or documented exploratory measures were also assessed. Alcohol, drugs and nicotine-use information, as well as the Revised Illness Perception Questionnaire 9, are reserved for a distinct secondary exploratory analysis and are not part of the primary efficacy evaluation.
Read the detailed description
RePSO was a single-center, randomized, controlled, parallel-group superiority trial with three groups.
All participants continued dermatological treatment selected by their treating clinician.
Participants allocated to the active control completed a standardized online audio program comprising Romanian poetry or short stories presented over relaxing background music.
Participants allocated to therapist-guided receptive music therapy received an individualized online program informed by an initial music-therapy interview and weekly structured feedback. Both audio programs prescribed three 20-minute sessions per week for four weeks, for a total of 12 sessions.
The principal estimand compared therapist-guided receptive music therapy with the audio-based active control at the three-month post-intervention assessment for the Dermatology Life Quality Index, perceived stress visual analog scale, Generalized Anxiety Disorder-7, and Patient Health Questionnaire-9, using a treatment-policy strategy for changes in concomitant dermatological care.
The six-month assessment evaluated persistence of effects. Clinician-rated psoriasis severity was assessed by outcome assessors who were unaware of randomized allocation.
Information on alcohol use, assessed using the Alcohol Use Disorders Identification Test (AUDIT), nicotine and other drug use, and illness perceptions, assessed using the Revised Illness Perception Questionnaire, was collected as part of the study's broader behavioral and psychosocial assessment. These variables are reserved for a separate secondary exploratory analysis of the RePSO dataset. Any resulting publication will identify the trial registration (NCT05894759), distinguish randomized treatment effects from nonrandomized associations involving substance use and illness perceptions, and avoid duplicating the analyses and findings reported in the primary psoriasis manuscript.
- Conditions
- Psoriasis (PsO), Psychological Distress, Depressive Symptom, Anxiety
- Being tested
- Therapist-guided receptive music therapy, Audio-based active relaxation control
- Keywords
- psychodermatology; receptive music therapy; digital health; quality of life; perceived stress; alcohol use; secondary analysis
- Medical subject headings
- Psoriasis, Depression, Anxiety Disorders, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapist-guided receptive music therapyBehavioural
An online individualized receptive music therapy program delivered over four weeks by a music therapist. The program included an initial music-therapy interview, three 20-minute sessions per week, weekly structured feedback, and therapist-led playlist adaptation. Participants received unique website credentials, technical support, and wired over-ear headphones.
Audio-based active relaxation controlBehavioural
A standardized four-week online listening program comprising Romanian poetry or short stories presented over relaxing background music. Participants completed three 20-minute sessions per week. The comparator matched structured online listening, session duration, headphone use, relaxing audio exposure, and treatment expectancy as far as practicable, but did not include individualized selection, therapist guidance, or feedback-based adaptation.
| Study group | Role | What they receive |
|---|---|---|
| TAU | No intervention | Participants continued usual dermatological care selected by the treating clinician and received no additional study relaxation program during the four-week intervention period. |
| Audio-based active relaxation control plus treatment as usual | Active comparator | Participants continued usual dermatological care and completed a standardized online program of Romanian poetry or short stories presented over relaxing background music. The program comprised three 20-minute sessions per week for four weeks. It did not include individualized music selection, therapist guidance, or feedback-based adaptation. Receives: Behavioral: Audio-based active relaxation control |
| Therapist-guided receptive music therapy plus treatment as usual | Experimental | Participants continued usual dermatological care and completed 12 online receptive music therapy sessions over four weeks. An initial interview informed an individualized playlist. Weekly structured feedback was reviewed by the music therapist and used to retain or adapt the playlist. Receives: Behavioral: Therapist-guided receptive music therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Dermatology Life Quality Index score
The Dermatology Life Quality Index is a 10-item patient-reported measure scored from 0 to 30; higher scores indicate greater dermatology-related impairment. The principal treatment comparison was the baseline-adjusted score at three months after the four-week intervention.
Measured: Baseline; end of the 4-week intervention; 3 months and 6 months after intervention
Change in perceived psychological stress visual analog scale score
Participants rated perceived psychological stress on a 0-to-10 visual analog scale, where 0 indicates no perceived psychological stress and 10 indicates the greatest imaginable psychological stress. The principal treatment comparison was the baseline-adjusted score at three months after the four-week intervention.
Measured: Baseline; end of the 4-week intervention; 3 months and 6 months after intervention
Change in Generalized Anxiety Disorder-7 score
The Generalized Anxiety Disorder-7 is scored from 0 to 21; higher scores indicate greater anxiety symptom severity. The principal treatment comparison was the baseline-adjusted score at three months after the four-week intervention.
Measured: Baseline; end of the 4-week intervention; 3 months and 6 months after intervention
Change in Patient Health Questionnaire-9 score
The Patient Health Questionnaire-9 is scored from 0 to 27; higher scores indicate greater depressive symptom severity. The supplementary functional-impact item was recorded separately and was not included in the total score. The principal treatment comparison was the baseline-adjusted score at three months after the four-week intervention.
Measured: Baseline; end of the 4-week intervention; 3 months and 6 months after intervention
Secondary outcomes (13)
Change in Psoriasis Area and Severity Index score
0-72; higher scores indicate greater severity. Clinician-rated by a masked assessor.
Measured: Baseline; end of the 4-week intervention; 3 and 6 months after intervention
Change in Self-Administered Psoriasis Area and Severity Index score
0-72; higher scores indicate greater self-rated severity.
Measured: Baseline; end of the 4-week intervention; 3 and 6 months after intervention
Change in dermatological treatment adherence visual analog scale score
0-10; 0 indicates no adherence and 10 complete adherence during the preceding month.
Measured: Baseline; end of the 4-week intervention; 3 and 6 months after intervention
Participants with a clinically meaningful DLQI improvement
Reduction of at least 4 points from baseline.
Measured: end of the 4-week intervention; 3 and 6 months after intervention
Participants achieving PASI50 and PASI75
At least 50% and 75% reduction from baseline PASI.
Measured: end of the 4-week intervention; 3 and 6 months after intervention
Changes in Erythema, Scaling, Induration, and Fissuring Score
0-48; higher scores indicate greater disease severity.
Measured: Baseline; end of intervention; 3 and 6 months after intervention
Change in Psoriasis Scalp Severity Index Score
0-72; higher scores indicate greater disease severity.
Measured: baseline; end of the 4-week intervention; 3 and 6 months after intervention
Change in Nail Psoriasis Severity Index Score
0-80 when only the fingernails were evaluated; 0-160 when both fingernails and toenails were evaluated; higher scores indicate greater disease severity.
Measured: baseline; end of the 4-week intervention; 3 and 6 months after intervention
Number of patient-reported psoriasis recurrence or exacerbation episodes
Distinct worsening episodes reported over the visit-specific recall interval.
Measured: 1-month recall at end of intervention; 3-month recall at FU3; 6-month recall at FU6
Number of prescribed audio sessions completed
Number completed out of 12; applicable to the two audio groups.
Measured: During the 4-week intervention
Baseline alcohol use risk assessed with the Alcohol Use Disorders Identification Test (AUDIT)
Alcohol use was assessed at baseline only using the Alcohol Use Disorders Identification Test (AUDIT). The AUDIT total score ranges from 0 to 40, with higher scores indicating greater risk related to alcohol use. This baseline measure was collected for exploratory observational analyses of the association between alcohol use risk and baseline psoriasis severity, dermatology-specific quality of life, perceived stress, anxiety, and depressive symptoms. It was not collected after randomization and was not used to assess an intervention effect.
Measured: Baseline (before randomization)
Tobacco/nicotine use and illicit drug use
Tobacco/nicotine use and illicit drug use were assessed using a study-specific self-report questionnaire at baseline, at the end of the 4-week intervention, and at 3- and 6-month follow-up. Tobacco/nicotine items recorded current or past use, product type (combustible cigarettes, heated tobacco products, or electronic cigarettes), cigarettes per day for combustible or heated tobacco products, average daily hours of electronic-cigarette use, duration of use, and participant-perceived change in psoriasis associated with nicotine use. Illicit-drug items recorded current or past use, substances reported, and participant-perceived change in psoriasis associated with illicit-drug use. These measures were collected as exploratory descriptive variables and were not primary or secondary efficacy outcomes of the randomized intervention.
Measured: Baseline; end of the 4-week intervention; 3 and 6 months after intervention
Illness perceptions
Illness perceptions were assessed using the Revised Illness Perception Questionnaire (IPQ-R), with items worded specifically in relation to psoriasis, at baseline, at the end of the 4-week intervention, and at the 3- and 6-month follow-up assessments. The questionnaire evaluated symptom identity and attribution, perceived consequences, acute or chronic timeline, cyclical timeline, personal control, treatment control, illness coherence, emotional representations, and beliefs regarding possible causes of psoriasis. The IPQ-R dimensions were treated as separate constructs and were not combined into an overall score. These measures were collected as secondary patient-reported outcomes and were reserved for a separate exploratory analysis rather than included among the randomized trial's primary efficacy outcomes.
Measured: Baseline; end of the 4-week intervention; 3 and 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start15 Jun 2023
- Primary completion29 Apr 2025
- Study completion5 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis (PsO)Studies 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
- Participants were randomized in a 1:1:1 ratio to one of three parallel groups: treatment as usual alone; treatment as usual plus an audio-based active relaxation control; or treatment as usual plus online therapist-guided receptive music therapy. Randomization used randomly permuted blocks of 3 and 6. Each participant remained in the assigned group throughout the study, with no crossover between groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grigore T. Popa University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bogdan-Marian Tarcau, Grigore T. Popa University of Medicine and Pharmacy
- Investigators
- Laura Gheuca Solovastru, Study director, Grigore T. Popa University of Medicine and Pharmacy Iasi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05894759
- Sponsor's protocol ID
- 293/14.04.2023
- Acronym
- RePSO
- Status last verified
- Oct 2026
- First submitted
- 17 May 2023
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No