NCT06445855

Brief Summary

This study will be conducted to examine the effectiveness of interpersonal relationships-based online psychoeducation developed for women with sexual interest and arousal disorders.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 6, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

September 30, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

June 6, 2024

Status Verified

May 1, 2024

Enrollment Period

4 months

First QC Date

May 31, 2024

Last Update Submit

May 31, 2024

Conditions

Keywords

Sexual Arousal DisorderSexual Desire DisorderOnline Intervention ProgramSexual Interest/ Arousal Disorder

Outcome Measures

Primary Outcomes (1)

  • Sexual Interest and Desire Inventory-Female (SIDI-F)

    The inventory is a 13-item inventory developed to measure the level of sexual interest and arousal of women specifically in the last 4 weeks. A total score between 0 and 51 is obtained from the SIDI-F. The cut-off score of the inventory is 33 and 94.7% of the women below this score have a sexual interest and desire disorder.

    12 weeks

Secondary Outcomes (4)

  • Female Sexual Distress Scale-Revised

    12 weeks

  • Female Sexual Function Index (FSFI)

    12 weeks

  • Interpersonal Relationship Dimensions Scale

    12 weeks

  • System Usability Scale (SUS-TR)

    12 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

Women in the experimental group will receive an 8-week online intervention program based on interpersonal relationships. An internet-based intervention application will be developed for this intervention. All interventions will be implemented from this intervention.

Behavioral: Interpersonal relationship-based intervention program

Waiting group

OTHER

After the interventions in the experimental group are completed, the intervention program will be applied to the women in the waiting group.

Behavioral: Interpersonal relationship-based intervention program

Interventions

An interpersonal relations-based intervention program will be implemented with an online intervention platform.

Experimental groupWaiting group

Eligibility Criteria

Age18 Years - 47 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • A person of female biological sex,
  • Expressing difficulties in sexual interest and arousal (yes to at least three of the following criteria) (questions related to these criteria will be added to the interview form)
  • Decrease/absence in frequency or intensity of sexual activity,
  • Decrease/absence of sexual fantasies/erotic thoughts,
  • Inability to initiate sexual intercourse with their partner,
  • Lack of sexual excitement and pleasure in almost all sexual relationships (about 75%),
  • Decreased/absence of sexual interest/arousal to internal or external sexual erotic stimuli (e.g. written, oral, visual),
  • Decreased/absence of genital or nongenital sensations in almost all sexual relationships (approximately 75%).
  • Low mean scores on the Female Sexual Function Index and Sexual Interest and Desire Inventory-Female scales (mean score on the Female Sexual Function Index below 26.55, mean score on the Sexual Interest and Desire Inventory-Female below 33)
  • Have sufficient knowledge about the use of the Internet,

You may not qualify if:

  • Becoming pregnant or planning pregnancy during the psychoeducation period,
  • Receive treatment for any sexual dysfunction,
  • Withdrew from the study at any stage of the study,
  • Women who do not attend more than one session of the psychoeducation will not be included in the study (Women who miss the weekly program of the psychoeducation will be allowed a maximum of 2 make-up sessions).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Women to be included in the study will be divided into two groups after randomization. The first group will be the experimental group and the second group will be the waiting group. The experimental group will receive 8 weeks of interpersonal relationship-based online psychotherapy.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: One waiting group and one experimental group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD Student

Study Record Dates

First Submitted

May 31, 2024

First Posted

June 6, 2024

Study Start

September 30, 2024

Primary Completion

January 30, 2025

Study Completion

June 30, 2025

Last Updated

June 6, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share