NCT06484400

Brief Summary

Title: Comparison of Cognitive Behavioral Therapy and Ericksonian Hypnosis Therapy for Depression and Anxiety Symptoms; A Controlled Randomized Study. Principal Investigator: Dr. Metin Çınaroğlu, Istanbul Nişantaşı University, Department of Psychology. Study Duration: October, 2023 - Ongoing. Objective: The study aims to compare the effectiveness of Cognitive Behavioral Therapy (CBT) and Ericksonian Hypnotherapy in alleviating symptoms of depression and anxiety among volunteers in Istanbul. Methods: This randomized controlled trial will enroll healthy individuals aged 18-65 who exhibit symptoms of depression and anxiety but are not clinically diagnosed. Participants will be randomly divided into three groups: one receiving CBT, another receiving Ericksonian Hypnotherapy, and a control group receiving no therapeutic intervention. Standard psychological assessment tools such as the Beck Depression Inventory and Beck Anxiety Inventory will be used to measure outcomes. Significance: Depression and anxiety are prevalent psychological disorders that significantly impair quality of life. Comparing these two therapeutic approaches may provide valuable insights into more effective psychological treatment strategies, thereby enhancing patient care in mental health settings. Study Protocol: Recruitment: 150 volunteers will be screened using socio-demographic forms and psychological assessments. Intervention: Participants will undergo CBT or Ericksonian Hypnotherapy according to their group allocation, while the control group will be observed without intervention. Evaluation: Pre- and post-treatment assessments will gauge the therapy's impact on depression and anxiety symptoms. Expected Outcome: The study expects to demonstrate the relative efficacy of CBT and Ericksonian Hypnotherapy, providing evidence to guide treatment choices for managing depression and anxiety symptoms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 4, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2024

Completed
Last Updated

January 22, 2025

Status Verified

January 1, 2025

Enrollment Period

11 months

First QC Date

June 26, 2024

Last Update Submit

January 17, 2025

Conditions

Keywords

Cognitive Behavioral Therapy (CBT)Ericksonian HypnotherapyDepressive DisorderAnxiety DisordersNon-clinical Symptomatic Population

Outcome Measures

Primary Outcomes (2)

  • Change in Beck Depression Inventory (BDI) Scores

    This outcome measures the change in depression levels among participants, as assessed by the Beck Depression Inventory. The BDI is a 21-item self-reported inventory that rates the severity of depression symptoms such as sadness, pessimism, sense of failure, and satisfaction in life, among others. The primary measure will be the difference in scores from baseline (pre-intervention) to post-intervention, indicating the efficacy of Cognitive Behavioral Therapy and Ericksonian Hypnotherapy in reducing depressive symptoms.

    Baseline and 12 weeks post-intervention

  • Change in Beck Anxiety Inventory (BAI) Scores

    This outcome measures the change in anxiety levels, assessed using the Beck Anxiety Inventory. The BAI is a 21-item self-reported scale that evaluates the severity of anxiety symptoms, including nervousness, fear, and physiological responses related to anxiety. The main focus will be on the difference in scores from baseline to after the completion of the interventions, showcasing the impact of the therapeutic approaches on anxiety reduction.

    Baseline and 12 weeks post-intervention

Study Arms (3)

Cognitive Behavioral Therapy (CBT) Group

EXPERIMENTAL

Participants in this group will receive Cognitive Behavioral Therapy, which involves identifying and modifying negative thought patterns and behaviors to alleviate symptoms of depression and anxiety. Therapy sessions are conducted in person and on a one-on-one basis, ensuring tailored and direct therapeutic engagement. Each participant will attend 12 weekly sessions, each lasting approximately one hour.

Behavioral: Cognitive Behavioral Therapy

Ericksonian Hypnotherapy Group

EXPERIMENTAL

This group will receive Ericksonian Hypnotherapy, a therapeutic approach that utilizes techniques of hypnosis and suggestion to access and alter subconscious processes, aiming to reduce psychological distress associated with depression and anxiety. Similar to the CBT group, sessions are delivered in person on a one-on-one basis, with a total of 12 weekly sessions, each one hour long.

Behavioral: Ericksonian Hypnotehrapy

Control Group

NO INTERVENTION

Participants in this group will not receive any active intervention during the study period. This group serves as a control to measure the natural progression of depression and anxiety symptoms without therapeutic intervention. Participants will be monitored throughout the study and will be offered therapeutic sessions after the study's conclusion as compensation for their participation.

Interventions

Cognitive Behavioral Therapy (CBT) is a well-established psychological treatment that focuses on identifying, understanding, and changing negative thinking and behavior patterns. The intervention involves structured sessions where participants are taught strategies to alter detrimental thoughts and behaviors to improve emotional regulation and develop personal coping strategies that target solving current problems. In this study, CBT will be delivered in 12 one-hour weekly sessions conducted in person and on a one-on-one basis. This intervention is designed to reduce symptoms of depression and anxiety through cognitive restructuring and behavioral adaptations.

Cognitive Behavioral Therapy (CBT) Group

Ericksonian Hypnotherapy is a form of psychotherapy using clinical hypnosis and indirect suggestion to modify unconscious behaviors and thought patterns. Named after Dr. Milton H. Erickson, this therapeutic approach emphasizes adaptability and utilizes the patient's own experiences and internal resources for healing. The therapy is known for its effectiveness in addressing anxiety and depression by encouraging flexibility in perception and behavior. Like CBT, this intervention will be administered over 12 one-hour sessions, each conducted in person and tailored to the individual's unique psychological landscape.

Ericksonian Hypnotherapy Group

Eligibility Criteria

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

You may qualify if:

  • Age: Participants must be between 18 and 65 years old.
  • Symptoms: Participants must display symptoms of depression and/or anxiety, but not necessarily have a clinical diagnosis.
  • Voluntary Participation: Participants must voluntarily agree to participate and must be able to provide informed consent.
  • Residency: Participants must reside in or near the study location (Istanbul) to attend in-person sessions.
  • Language: Participants must be proficient in the language in which the therapy is delivered (presumably Turkish).
  • Availability: Participants must be available to attend all scheduled sessions over the course of the study (12 weekly sessions).

You may not qualify if:

  • Psychiatric Diagnosis: Individuals with a severe psychiatric disorder requiring immediate or intensive intervention (e.g., schizophrenia, bipolar disorder, or severe depression with suicidal ideation).
  • Current Psychotherapy: Individuals currently receiving other forms of psychotherapy or psychological treatment.
  • Substance Abuse: Individuals with active substance abuse issues or dependencies that could interfere with therapy.
  • Cognitive Impairments: Individuals with cognitive impairments or neurological disorders that would limit their ability to participate fully in therapy.
  • Medical Conditions: Individuals with severe medical conditions that could interfere with participation in the study or pose a risk during the therapy sessions.
  • Language Barrier: Non-Turkish speakers or those who do not understand the language well enough to benefit from therapy conducted in Turkish.
  • Previous Participation: Individuals who have previously participated in similar studies or interventions, to avoid potential biases in responses and outcomes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Metin Çınaroğlu

Istanbul, 34277, Turkey (Türkiye)

Location

MeSH Terms

Conditions

DepressionAnxiety DisordersDepressive Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersMood Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Cemre Odabaşı, MA

    Clinical Psychology MA Student

    PRINCIPAL INVESTIGATOR
  • Fadime Çınar, phd

    Associate Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Model Description: This study employs a randomized, controlled, parallel-group design to compare the effectiveness of Cognitive Behavioral Therapy (CBT) and Ericksonian Hypnotherapy in treating symptoms of depression and anxiety. The study includes three arms: CBT Group: Participants in this group will receive Cognitive Behavioral Therapy aimed at modifying negative thought patterns and behaviors to alleviate symptoms of depression and anxiety. Ericksonian Hypnotherapy Group: This group will undergo Ericksonian Hypnotherapy, which uses hypnosis and indirect suggestion to influence subconscious processes and mitigate psychological distress. Control Group: Participants in this group will not receive any intervention during the study period but will be monitored and offered therapy sessions after the study concludes, serving as a comparator to evaluate the efficacy of the interventions.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asistant Professor

Study Record Dates

First Submitted

June 26, 2024

First Posted

July 3, 2024

Study Start

October 4, 2023

Primary Completion

September 1, 2024

Study Completion

November 25, 2024

Last Updated

January 22, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

Description: The research team intends to make de-identified individual participant data (IPD) and supplementary materials available to further scientific investigation, ensure transparency, and encourage data reuse. Data and Supplementary Materials to be Shared: The shared dataset will include de-identified demographic data, baseline and post-intervention outcomes measured by the Beck Depression Inventory and the Beck Anxiety Inventory, session attendance records, and any additional assessments performed as part of the study. Supplementary materials such as session protocols, statistical analysis scripts, and intervention manuals will also be made available.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
The dataset and supplementary materials will be available indefinitely to maximize the impact and utility of the research contributions.
Access Criteria
All materials will be accessible without the need for a specific request or proposal submission, promoting an open and collaborative research environment.
More information

Locations