Clinical trial NCT02304796: Unified Cognitive-Behavioral Therapy (CBT) vs. Combined CBT and Dance/Movement Therapy (DMT) for Anxiety Disorders
Official title: Randomized Controlled Trial Examining the Effectiveness of Two Group Psychotherapies for Anxiety Disorders: Unified Cognitive-behavioral Therapy vs. Combined Cognitive Behavioral and Dance/Movement Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety Disorders
Keywords: Anxiety Disorders
Group Psychotherapy
Cognitive-Behavioral Therapy
Dance/Movement Therapy
CBT
DMT
Unified Protocol
Lead sponsor: Shalvata Mental Health Center
Sponsor class: OTHER
First posted: 2014-12-02
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The current pilot study will examine and compare the effectiveness of two group psychotherapies for mixed anxiety disorders: 1. unified cognitive-behavioral protocol, adapted to a group format. 2. combined cognitive-behavioral and dance/movement therapy.

In addition, change in proposed mechanism in each therapy will be examined, along with their association with change in outcome measures during therapy.

Detailed description: The current pilot study will examine and compare the effectiveness of two group psychotherapies for mixed anxiety disorders: 1. unified cognitive-behavioral protocol, adapted to a group format. 2. combined cognitive-behavioral and dance/movement therapy.

24 patients will be randomized to 1 of the two treatment arms and treated with 20 weekly 1.5-2 hours therapy sessions. Independent evaluator and self-reports measures will be collected at intake, pre-treatment, session by session, post-treatment and and follow-up.

Hypotheses:

1. Both groups will show effectiveness, as revealed by reduction in anxiety severity and increase in valued living.
2. Changes in process measures (proposed mechanism of change - emotion regulation, working alliance, fear of bodily sensations, bodily/movement awareness) will be predictive of change in outcome measures (anxiety severity and valued living).
3. Changes in bodily/movement awareness will be more predictive of change in outcome measures in the CBT-DMT group than in the unified protocol group.

Eligibility criteria: Inclusion Criteria:

* One of the following primary axis I DSM-IV-TR diagnoses: Panic disorder with or without Agoraphobia; Social Anxiety Disorder; Generalized Anxiety Disorder; Anxiety Disorder Not Otherwise Specified; Adjustment Disorder With Anxiety; Adjustment Disorder With Mixed Anxiety and Depressed Mood
* If on medication or in other types of treatments, patients must be willing to remain stable on their treatment for the duration of the acute phase of the study (5-6 months)
* Provision of written informed consent

Exclusion Criteria:

* Current or past schizophrenia, psychosis, or bipolar disorder.
* Current suicidal ideation.
* Current substance/alcohol dependence or abuse.
* Cluster A or B personality disorder.
* Pregnancy (for women).

Primary outcomes:
measure: Change in Hamilton Anxiety Rating Scale
timeFrame: Intake (entry to study), Pre-treatment (1 month from intake), Post-Treatment (6 months from intake), Follow-Up (7 months from intake)
Secondary outcomes:
measure: Change in Depression, Anxiety, Stress Scales-21
timeFrame: Intake (entry to study), Weekly during treatment (weekly between 1-6 months from intake), Post-Treatment (6 months from intake), Follow-Up (7 months from intake)
measure: Change in Valued Living Questionnaire
timeFrame: Intake (entry to study), Pre-treatment (1 month from intake), Mid-Treatment (3.5 months from intake), Post-Treatment (6 months from intake), Follow-Up (7 months from intake)
measure: Change in Mini International Neuropsychiatric Interview
timeFrame: Intake (entry to study), Pre-treatment (1 month from intake), Post-Treatment (6 months from intake), Follow-Up (7 months from intake)
Other outcomes:
measure: Change in Difficulties in Emotion Regulation Scale
timeFrame: Intake (entry to study), Weekly during treatment (weekly between 1-6 months from intake), Post-Treatment (6 months from intake), Follow-Up (7 months from intake)
measure: Change in Body Sensations Questionnaire
timeFrame: Intake (entry to study), Pre-treatment (1 month from intake), Mid-Treatment (3.5 months from intake), Post-Treatment (6 months from intake), Follow-Up (7 months from intake)
measure: Change in Bodily Awareness of Emotions Subscale of the Emotion Awareness Questionnaire - Revised
timeFrame: Intake (entry to study), Pre-treatment (1 month from intake), Mid-Treatment (3.5 months from intake), Post-Treatment (6 months from intake), Follow-Up (7 months from intake)
measure: Change in Working Alliance Inventory - Short and Revised form - Group version
timeFrame: Intake (entry to study), Pre-treatment (1 month from intake), Session 5 (2 months from intake), Mid-Treatment (3.5 months from intake), Post-Treatment (6 months from intake), Follow-Up (7 months from intake)
Locations:
city: Hod Hasharon
country: Israel
facility: Shalvata Mental Health Center
Study officials:
affiliation: Shalvata Mental Health Center
name: Yuval Bloch, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barlow DH, Farchione TJ, Fairholme CP, Ellard KK, Boisseau CL, Allen LB, Ehrenreich-May J. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders: Therapist Guide. New York: Oxford University Press: 2011.