In-home Decluttering Augmentation of Group CBT for HD
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|ClinicalTrials.gov Identifier: NCT04712474|
Recruitment Status : Recruiting
First Posted : January 15, 2021
Last Update Posted : January 15, 2021
|Condition or disease||Intervention/treatment||Phase|
|Hoarding Disorder||Behavioral: In-home decluttering practice||Not Applicable|
Primary objective: To determine the clinical efficacy of in-home decluttering augmentation of group CBT for reducing hoarding severity in adults with HD.
Secondary objectives: To assess the cost-effectiveness of in-home decluttering, from a social services provider perspective. Type of trial: Single-blind parallel-group randomized controlled superiority trial.
Participants who are eligible and have consented to participate in the trial will receive protocol-driven group CBT for HD for 12 weeks. After group CBT, participants are immediately randomized to one of two trial arms. In the experimental arm, participants receive 10 weeks of in-home decluttering. In the waitlist arm, participants receive no intervention but fill out questionnaires with identical procedures as in the intervention group.
Participants will complete outcome measures at pre-CBT, mid-CBT (week 6), baseline (i.e. immediately after receiving CBT and before inhome decluttering), twice during in-home decluttering (week 4 and 7), post-treatment (week 10 of in-home decluttering), and 3-, 6-, and 12- months post-treatment. Two primary outcome variables will be used in this study; the total score on the Saving Inventory- Revised (SI-R) and the total score on the clinician-reported Clutter Image Rating (CIR). The primary endpoint is post-treatment (i.e. week 10 of in-home decluttering or waitlist).
Secondary outcomes include participants' cognitions about discarding (SCI), relationship between self and items (RSI), measures of clutter (CIR), squalor (HEI), impairment of daily functioning (ADL-H), severity and improvement (CGI), adverse events, and treatment satisfaction (CSQ8). Relatives of trial participants will rate levels burden and accommodation with the Family Impact Scale for Hoarding Disorder (FISH) and the Caregiver Burden Inventory (CBI), respectively. The Trimbos Questionnaire for Costs associated with Psychiatric Illness will be used to assess healthcare and societal resource use. Follow-up assessments will be conducted at the clinic or via videoconferencing.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||In-home Decluttering Augmentation of Group Cognitive-behavior Therapy for Hoarding Disorder: The Joining Forces Randomized Controlled Trial|
|Estimated Study Start Date :||January 13, 2021|
|Estimated Primary Completion Date :||January 15, 2024|
|Estimated Study Completion Date :||January 15, 2025|
Experimental: In-home decluttering
Study participants receive weekly sessions of in-home decluttering for 10 weeks.
Behavioral: In-home decluttering practice
The in-home decluttering intervention comprises 10, 1.5-hour home-visits over the course of 10 weeks.
These home visits are personalized, goal-oriented and focused on decluttering. They include 1) a brief check-in, 2) guided unclutter time 3) a reflective period during which participants share their thoughts and objectives for the coming week, and 4) homework assignments.
No Intervention: Delayed treatment
Study participants receive weekly session of in-home decluttering after a 10 week delay.
- Saving Inventory-Revised (SI-R) [ Time Frame: Change from baseline (week 0) to post-treatment (week 10), ]The SI-R is a 23-item questionnaire with 3 sub-scales: 1) difficulty discarding, 2) excessive clutter, and 3) excessive acquisition.
- Clutter Image Rating Scale (CIR) [ Time Frame: Change from baseline (week 0) to post-treatment (week 10). ]Three sets of photographs, each comprising 9 photos of a room with varying levels of clutter. A selection is made as to which photograph best resembles the room of the participant.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04712474
|Contact: Sofia Jägholm, MScfirstname.lastname@example.org|
|Contact: Volen Ivanov, PhDemail@example.com|
|M46: Karolinska Universitetssjukhuset, Psykiatri Sydväst Stockholm, Huddinge, Sweden, 141 86||Recruiting|
|Stockholm, Sweden, 141 86|
|Contact: Volen Ivanov, PhD firstname.lastname@example.org|
|Principal Investigator:||Volen Ivanov, PhD||Karolinska Institutet|