Generalized Anxiety Disorder, Major Depressive Disorder, Obsessive-Compulsive Disorder
Conditions
Keywords
OCD, GAD, MDD, Rumination, Obsession, Worry, Attention
Brief summary
The investigators are conducting this study to learn more about the cognitive and attentional processes among individuals with three types of repetitive negative thinking (RNT): mental rituals (as seen in obsessive compulsive disorder, OCD), worries (as seen in generalized anxiety disorder, GAD), and ruminations (as seen in major depressive disorder, MDD). Specifically, the investigators are studying whether psychological treatment can help people with RNT who have trouble stopping unwanted thoughts and shifting their attention.
Detailed description
The current study will examine whether enhancing attention regulation skills in a transdiagnostic intervention for repetitive negative thinking (RNT) will significantly improve the target of attentional/cognitive control. Phase 1 is an open pilot trial in which participants will be assigned to eight 60 minute sessions (over 8 weeks) of Emotion Regulation Therapy-Attention Regulation (AR-ERT). In Phase 2, participants will be randomly assigned (like the flip of a coin) to receive eight 60 minute sessions (over 8 weeks) of either: AR-ERT or Supportive Psychotherapy (SPT). The investigators will use a multi-method approach to measure attentional/cognitive control: (a) behavioral (i.e., eye tracking fixations and reaction time), (b) electrophysiological (i.e., event related potentials), and (c) self-report (i.e., perceived ability to shift and focus attention). They also will examine early signs of treatment efficacy of AR-ERT and SPT and target validation (i.e., whether changes in attentional/cognitive control correlate with changes in RNT and associated symptoms). Participants will receive assessments of these target and outcome measures at baseline (week 0), mid-treatment (week 4), post-treatment (week 8), and 3-month follow-up (week 20 - Phase 2 only). While most of these procedures are conducted virtually (e.g., therapy sessions), some (e.g., eye tracking and electrophysiological assessments) will be performed in-person. Findings could help identify a cross-cutting target that can be engaged to optimize treatment response for individuals with elevated RNT.
Interventions
BEHAVIORALEmotion Regulation Therapy - Attention Regulation (AR-ERT)
Participants will receive a total of eight 60 minute sessions (over 8 weeks) of individual, manual-based AR-ERT. This intervention aims to build attention regulation skills (i.e., the ability to flexibly shift and sustain attention) by teaching participants exercises for Orienting their attention and Allowing the presence of negative emotions. Participants are taught to apply these skills to counteract reactive perseverative thinking when negative emotions arise as well as proactively engage with emotion-laden situations that trigger repetitive negative thinking.
BEHAVIORALSupportive Psychotherapy (SPT)
Participants will receive a total of eight 60 minute sessions (over 8 weeks) of individual, manual-based SPT. This intervention addresses factors that may affect participants' repetitive negative thinking symptoms (for example, relationships, work, stress), and teaches skills for managing challenges by improving self-esteem and positive coping skills.
Sponsors
Massachusetts General Hospital
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Independent evaluators will remain blind to treatment condition throughout the study for all participants. Participants and study therapists will be aware which treatment they have been assigned to.
Intervention model description
Phase 1: All participants will receive AR-ERT. Phase 2: At the baseline visit, eligible participants will be randomized (1:1 in parallel) to AR-ERT or SPT.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Adults ages 18-60 years old * Right-handed * Living in Massachusetts * Repetitive Negative Thinking (RNT) in the form of mental rituals, worries, and/or depressive ruminations is the primary reason for seeking treatment * RNT significant enough to warrant intervention * Fluent in English, willing to provide informed consent, and willing to comply with the study protocol * Access to a device with an internet connection, camera, and microphone (e.g., computer, smart phone, tablet) * Comfortable and capable of using a computer and completing reaction-time tasks
Exclusion criteria
* History of head injury or neurologic disease, mental retardation, or borderline intellectual functioning that would interfere with ability to participate in the study. * Impaired (or uncorrected) vision, medical illness, or medical treatment that would interfere with participation. * Active suicidal or homicidal ideation or any features requiring a higher level of care. * Lifetime psychotic disorder or bipolar disorder * Substance or alcohol use disorder that would interfere with treatment. * Current Attention Deficit Hyperactivity Disorder (ADHD) that would interfere with attentional tasks. * Unstable dose of psychotropic medications or recent discontinuation of psychotropic medication. * Current psychotherapy or plans to initiate such treatment during the study. * Previous course of treatment with cognitive behavioral therapy and/or mindfulness/meditation for obsessive compulsive disorder (OCD), generalized anxiety disorder (GAD), or depression.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Transdiagnostic Repetitive Negative Thinking (Measured by the Perseverative Thinking Questionnaire [PTQ]) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial | Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up) | 15-item self-report measure of transdiagnostic repetitive negative thinking that includes items about thoughts as repetitive, intrusive, unproductive, and capturing mental capacity (e.g., "I think about many problems without solving any of them"). Total scores range from 0-60, with higher scores indicating more repetitive negative thinking (i.e., worse outcomes). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Worry (Measured by the Penn State Worry Questionnaire [PSWQ]) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial | Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up) | 16-item self-report measure of the tendency to engage in excessive, uncontrollable, and generalized worry (e.g., "I am always worrying about something"). Total scores range from 16-80, with higher scores indicating more worry (i.e., worse outcomes). |
| Rumination (Measured by the Rumination Response Scale [RRS]) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial | Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up) | 22-item self-report measure of the tendency to ruminate or dwell on one's distress and it's possible causes and consequences when feeling down, sad, or depressed (e.g., "Think about all your shortcomings, failings, faults, mistakes"). Total scores range from 22-88, with higher scores indicating more rumination (i.e., worse outcomes). |
| Mental Rituals (Measured by the Rumination on Obsessions and Compulsions Scale [ROCS] - Mental Neutralizing Subscale) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial | Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up) | The ROCS is a 33-item self-report measure that assesses the frequency of various mental responses to obsessional thoughts or images in the past month with 3 sub-scales: Mental Neutralizing, Acceptance, and Rumination on OCD symptoms (no total score is used). The Mental Neutralizing Sub-Scale is 18 items and specifically assesses mental rituals including arguing with oneself, reconstructing rituals, effort against thoughts, and distraction (e.g., "I feel compelled to collect all arguments that refute the intrusive thought or image"). Total scores (which are an average of the subscale items) range from 0-4, with higher scores indicating more mental rituals (i.e., worse outcomes). |
| OCD Symptom Severity (Measured by the Yale-Brown Obsessive-Compulsive Scale [Y-BOCS]) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial | Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up) | 10-item clinician-administered interview measure of past week symptom severity of obsessions and compulsions including: time, interference, distress, resistance, and control. Total scores range from 0-40, with higher scores indicating higher levels of OCD symptom severity (i.e., worse outcomes). |
| Generalized Anxiety Symptom Severity (Measured by the Structured Interview Guide for the Hamilton Anxiety Rating Scale [SIGH-A]) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial | Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up) | 14-item structured, clinician-administered interview measure of past week anxiety symptom severity including: anxious mood, tension, fears, insomnia, cognitive symptoms, depressed mood, somatic (muscular, sensory) symptoms, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and observed behavior. Total scores range from 0-56, with higher scores indicating higher levels of generalized anxiety symptoms (i.e., worse outcomes). |
| Depression Symptom Severity (Measured by the Structured Interview Guide for the Hamilton Depression Rating Scale [SIGH-D]) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial | Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up) | 17-item interview measure of past week depression symptom severity including: depressed mood, interest in work and activities, insomnia (early, middle, and late), genital symptoms, gastrointestinal somatic symptoms, loss of weight, general somatic symptoms, feelings of guilt, suicide, psychic anxiety, somatic anxiety, hypochondriasis, insight, agitation, retardation. Total scores range from 0-52, with higher scores indicating more depression (i.e., worse outcomes). |
| Functional Impairment (Measured by the Work and Social Adjustment Scale [WSAS]) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial | Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up) | 5-item self-report scale assessing disability in work, home management, social leisure activities, private leisure activities, and the ability to form and maintain close relationships. Total scores range from 0-40, with higher scores indicating more functional impairment (i.e., worse outcomes). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRyan J Jacoby, Ph.D.
Massachusetts General Hospital
Participant flow
Recruitment details
Phase I: 3 pilot participants were eligible and enrolled. Phase 2: 62 were eligible and randomized.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 31.07 Year STANDARD_DEVIATION 9.1 |
| Education College graduate | 3 Participants |
| Education Graduate or professional school | 17 Participants |
| Education High school graduate or less | 5 Participants |
| Education Some college | 5 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 10 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Region of Enrollment United States | 3 Participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 31 | 0 / 31 |
| other Total, other adverse events | 1 / 3 | 16 / 31 | 12 / 31 |
| serious Total, serious adverse events | 0 / 3 | 0 / 31 | 0 / 31 |
Outcome results
None listed