Cognitive Behavioral Therapy Versus Ericksonian Hypnosis Therapy for Depression and Anxiety Symptoms

Comparison of Cognitive Behavioral Therapy and Ericksonian Hypnosis Therapy for Depression and Anxiety Symptoms; Controlled Randomized Study

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.

Study Overview

• Status: Completed
• Conditions: Depression, Anxiety
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy; Behavioral: Ericksonian Hypnotehrapy

Detailed Description

Study Title: Comparison of Cognitive Behavioral Therapy and Ericksonian Hypnosis Therapy for Depression and Anxiety Symptoms; A Controlled Randomized Study.

Principal Investigator: Dr. Metin Çınaroğlu, Associate Professor, Department of Psychology, Istanbul Nişantaşı University.

Co-Investigators:

Expert Psychologist Dr. Eda Yılmazer, Department of Psychology, Beykoz University.

Psychologist Cemre Odabaşı, Clinical Psychology (Thesis) Student, Istanbul Nişantaşı University.

Dr. Selami Varol Ülker, Department of Psychology, Üsküdar University. Prof. Dr. Gökben Hızlı Sayar, Psychiatrist, Department of Psychiatry, Üsküdar University.

Study Duration: Start Date: October, 2023 - End Date: Ongoing.

Background and Rationale: Depression and anxiety are common mental health conditions globally, significantly impacting individuals' quality of life. Cognitive Behavioral Therapy (CBT) is widely recognized for its effectiveness in modifying dysfunctional thinking and behaviors associated with psychological disorders. Ericksonian Hypnotherapy, utilizing hypnotic suggestion and accessing unconscious processes, offers a complementary approach. This study aims to evaluate and compare the therapeutic efficacy of these interventions in non-clinically diagnosed, yet symptomatic individuals.

Objective: To compare the effectiveness of Cognitive Behavioral Therapy and Ericksonian Hypnotherapy in reducing symptoms of depression and anxiety.

Study Design: This is a randomized, controlled, comparative trial involving three groups:

CBT group (15 participants) Ericksonian Hypnotherapy group (15 participants) Waiting list control group (15 participants)

Methods:

Participants: A total of 150 volunteers from Istanbul, aged 18-65, displaying symptoms of depression and anxiety without a clinical diagnosis. Screening will be conducted using socio-demographic forms, the Beck Depression Inventory (BDI), and the Beck Anxiety Inventory (BAI).

Intervention: Participants will be randomly assigned to receive either CBT or Ericksonian Hypnotherapy, with each intervention being administered over 12 sessions. Each session will be conducted in person and on a one-on-one basis, lasting approximately one hour, held once a week.

Control Group: Individuals in the control group will not receive any intervention during the study period but will be offered therapy sessions after the study's conclusion as compensation for their participation.

Measurements: Psychological assessments will be conducted at baseline and post-intervention using the BDI and BAI to measure changes in depression and anxiety symptoms.

Data Analysis: The effectiveness of the interventions will be analyzed using independent and paired t-tests to compare pre- and post-intervention scores within and between groups. ANOVA will be utilized for comparing the three groups, and effect sizes will be calculated to determine the clinical significance of the treatments.

Ethical Considerations: The study will adhere to the ethical standards of the Helsinki Declaration and has been approved by the Institutional Review Board of Istanbul Nişantaşı University numbered 2023/3. Informed consent will be obtained from all participants, ensuring confidentiality and the right to withdraw from the study at any time without any consequences.

Significance: By directly comparing two distinct therapeutic modalities, this study seeks to provide empirical evidence to inform clinical practices and potentially guide future psychological interventions aimed at treating depression and anxiety.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34277
    • Metin Çınaroğlu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive Behavioral Therapy (CBT) Group; 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; 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.
Experimental: Ericksonian Hypnotherapy Group; 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; 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.
No Intervention: Control Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Istanbul Nisantasi University
• Investigators: Principal Investigator: Cemre Odabaşı, MA, Clinical Psychology MA Student; Principal Investigator: Fadime Çınar, phd, Associate professor

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2023
• Primary Completion (Actual): September 1, 2024
• Study Completion (Actual): November 25, 2024

Study Registration Dates

• First Submitted: June 26, 2024
• First Submitted That Met QC Criteria: June 26, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 17, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Depressive Disorder; Cognitive Behavioral Therapy (CBT); Anxiety Disorders; Ericksonian Hypnotherapy; Non-clinical Symptomatic Population
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Mood Disorders; Anxiety Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: Nisantasi University

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: The dataset and supplementary materials will be available indefinitely to maximize the impact and utility of the research contributions.
• IPD Sharing Access Criteria: All materials will be accessible without the need for a specific request or proposal submission, promoting an open and collaborative research environment.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No