NCT02314195

Brief Summary

Previous studies have highlighted the potential therapeutic benefits of receptive individual music therapy as an adjunct to standard care, in a variety of psychiatric ailments including mood and anxiety disorders. However, the role of music in the treatment of obsessive compulsive disorder have not been investigated to date. The present study therefore aimed to investigate the efficacy of music therapy as an adjunct to standard treatment, on obsessions in patients with treatment-naïve OCD. Moreover, given the fact that a significant proportion of patients with OCD have other comorbid mood or anxiety disorders, the question of whether therapeutic benefits of music could be expanded to also affect concurrent depressive and anxiety symptoms was explored.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 11, 2014

Completed
Last Updated

December 11, 2014

Status Verified

December 1, 2014

Enrollment Period

2 months

First QC Date

November 27, 2014

Last Update Submit

December 10, 2014

Conditions

Keywords

Obsessive Compulsive DisorderMusic Therapy/methodsCombined Modality TherapyAnxiety Disorders/therapy

Outcome Measures

Primary Outcomes (1)

  • Obsession (Maudsley Obsessive-Compulsive Inventory)

    Post-intervention scores on Maudsley Obsessive-Compulsive Inventory

    1 month

Secondary Outcomes (3)

  • Obsession subtype (Maudsley Obsessive-Compulsive Inventory sub-types)

    1 month

  • Anxiety symptoms (Beck Anxiety Inventory)

    1 month

  • Depressive symptoms (Beck Depression Inventory - Short Form)

    1 month

Study Arms (2)

Standard treatment + music therapy

ACTIVE COMPARATOR

Selective serotonin re-uptake inhibitor plus cognitive behavioral therapy. Music therapy encompassing 12 half-hour sessions of therapist-supervised receptive music therapy scheduled over four weeks

Drug: Selective serotonin re-uptake inhibitorBehavioral: Cognitive Behavioral TherapyOther: Music therapy

Standard treatment only

ACTIVE COMPARATOR

Selective serotonin re-uptake inhibitor plus cognitive behavioral therapy.

Drug: Selective serotonin re-uptake inhibitorBehavioral: Cognitive Behavioral Therapy

Interventions

A medication of selective serotonin re-uptake inhibitor (SSRI) family, Behavioral. The type and dosage of the medication was decided by the treating psychiatrist.

Also known as: Pharmacotherapy
Standard treatment + music therapyStandard treatment only

Cognitive Behavioral Therapy for obsessive compulsive disorder carried out by a psychologist.

Also known as: Psychotherapy
Standard treatment + music therapyStandard treatment only

12 sessions of 30-minute individual-based receptive music therapy, supervised by the treating psychiatrist.

Also known as: Receptive music therapy
Standard treatment + music therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • were at least 18 years or older;
  • had axis I diagnosis of OCD according to the criteria delineated by the diagnostic and statistical manual of mental disorders - fourth edition diagnosed by an experienced psychiatrist
  • had not received treatment previously for the disorder
  • agreed to partake in the study

You may not qualify if:

  • refused to partake in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shariati Hospital

Isfahan, Isfahan, 56465201, Iran

Location

MeSH Terms

Conditions

Obsessive-Compulsive DisorderAnxiety DisordersDepression

Interventions

Selective Serotonin Reuptake InhibitorsDrug TherapyCognitive Behavioral TherapyPsychotherapyMusic Therapy

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Neurotransmitter Uptake InhibitorsMembrane Transport ModulatorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesNeurotransmitter AgentsSerotonin AgentsPhysiological Effects of DrugsTherapeuticsBehavior TherapyBehavioral Disciplines and ActivitiesSensory Art TherapiesComplementary TherapiesRehabilitationAftercareContinuity of Patient CarePatient Care

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Shahrzad Shirani Bidabadi, M.S.c

Study Record Dates

First Submitted

November 27, 2014

First Posted

December 11, 2014

Study Start

April 1, 2014

Primary Completion

June 1, 2014

Study Completion

August 1, 2014

Last Updated

December 11, 2014

Record last verified: 2014-12

Locations