Completed

Pilot Trial of Cognitive and Behavioral Treatment of Compulsive Hoarding Compared to Wait List Control

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What is being tested

Cognitive Behavioral Treatment

Behavioral
Who is being recruted

Obsessive-Compulsive Disorder

Over 18 Years
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: September 2003

Summary

Principal SponsorBoston University Charles River Campus
Last updated: January 21, 2020
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2003Actual date on which the first participant was enrolled.

This study developed and tested a specialized cognitive and behavioral treatment for the symptoms of hoarding disorder, including excessive acquiring, difficulty discarding items, and extensive clutter in the home. Compulsive hoarding is characterized by excessive acquisition of possessions, difficulty discarding possessions, and excessive clutter. This condition is resistant to standard pharmacological and psychotherapeutic interventions that have proven effective in treating other obsessive compulsive spectrum disorders. This study aimed to determine the effectiveness of a specialized cognitive behavioral therapy (CBT) designed for treating hoarding symptoms. This study consists of three phases. In Phase 1, pilot data from previous studies were examined to develop an intervention suitable for use in a waitlist trial. In Phase 2, pilot study information were used to develop and test a treatment manual for compulsive hoarding. During this phase, treatment was applied flexibly to allow for variations in treatment duration and choice of techniques. During Phase 3, participants were randomly assigned to 26 weekly sessions of CBT or to a 12-week wait-list control, followed by active treatment for a fixed duration of 26 sessions. Therapist adherence and competence were assessed through audiotaped therapy sessions.

Official TitleCognitive and Behavioral Treatment of Compulsive Hoarding 
Principal SponsorBoston University Charles River Campus
Last updated: January 21, 2020
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
52 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment
: Everyone gets the same treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled
: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Obsessive-Compulsive Disorder
Criteria

Inclusion criteria: * Display at least moderately severe hoarding symptoms * Must live within 45 minutes of Boston, MA or Hartford, CT Exclusion criteria: * Ten or more sessions of cognitive behavior therapy for hoarding * Concurrent psychotherapy or medications * Suicidal, psychotic, or other psychiatric symptoms requiring hospitalization * Compulsive buying symptoms that are part of a manic phase of bipolar disorder * Mental retardation, dementia, brain damage, or other cognitive dysfunction that would interfere with the study


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Cognitive behavior therapy included 26 sessions of motivational enhancements; skills training for sorting, organizing and problem solving; direct practice not acquiring new items and discarding possessions to remove clutter and organize possessions; cognitive therapy to evaluate beliefs about possessions; and relapse prevention skills.
Group II
No Intervention
Participants waited to receive treatment for 12 weeks
Study Objectives
Primary Objectives

Self-report questionnaire of hoarding severity; total score range = 0 to 92; higher values indicate more symptoms
Secondary Objectives

Interviewer measure with 5 questions to assess hoarding severity; total score range = 0 to 40; higher values indicate more symptoms

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 2 locations
Suspended
Hartford Hospital, Institute of LivingHartford, United StatesSee the location
Suspended
BostonUCRCBoston, United States

Completed2 Study Centers