Clinical trial NCT06484400: Cognitive Behavioral Therapy Versus Ericksonian Hypnosis Therapy for Depression and Anxiety Symptoms
Official title: Comparison of Cognitive Behavioral Therapy and Ericksonian Hypnosis Therapy for Depression and Anxiety Symptoms; Controlled Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Anxiety
Keywords: Cognitive Behavioral Therapy (CBT)
Ericksonian Hypnotherapy
Depressive Disorder
Anxiety Disorders
Non-clinical Symptomatic Population
Lead sponsor: Istanbul Nisantasi University
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Beck Depression Inventory (BDI) Scores
timeFrame: Baseline and 12 weeks post-intervention
measure: Change in Beck Anxiety Inventory (BAI) Scores
timeFrame: Baseline and 12 weeks post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Metin Çınaroğlu
Study officials:
affiliation: Clinical Psychology MA Student
name: Cemre Odabaşı, MA
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor
name: Fadime Çınar, phd
role: PRINCIPAL_INVESTIGATOR
References: