EMI for Reducing Psychological Distress in Young Adults With Multiple ACEs: A RCT Study

Lead sponsor

Peking University is the lead sponsor of 418 studies on the registry; 122 are open to participants now.

Study arms

• Experimental
  EMI intervention

  EMI intervention targets three potentially modifiable transdiagnostic psychological processes: emotional clarity, self-esteem, and catastrophizing. The intervention includes brief ecological momentary assessments and tailored exercises addressing negative and positive emotional experiences.

  Behavioral: EMI

• No intervention
  Waitlist control group

  Participants assigned to the waitlist control group will not receive the ecological momentary intervention (EMI) during the intervention and follow-up periods. They will complete the same outcome assessments as participants in the EMI intervention group. In addition, participants will undergo brief weekly assessments to identify any significant deterioration in mental health and assess suicide risk. After completing the final follow-up assessment, participants in the waitlist control group will be offered access to the same 2-week smartphone-based EMI program.

Interventions

• BehavioralEMI

  The ecological momentary intervention (EMI) is a 2-week smartphone-based intervention delivered in participants' daily lives. At the beginning of the intervention, participants will watch an approximately 10-minute psychoeducational video introducing the psychological principles underlying the intervention and the purposes of the exercises. They will then receive instructions on how to use the EMI program. During the intervention period, participants will receive brief ecological momentary assessments (EMAs) assessing their current emotional state. Based on their reported emotional valence, the program will provide tailored intervention content. When participants report negative or neutral emotional states (emotional valence ≤ 0), they will receive a negative-emotion module. This module includes brief breathing and grounding exercises, identification and labeling of current emotions, identification of potentially catastrophic or negative self-referential thoughts, cognitive reapprais

Primary outcomes

1. Psychological Distress

   Psychological distress will be assessed using the 6-item Kessler Psychological Distress Scale (K6). Each item is rated on a 5-point frequency scale from 0 to 4. Item scores are summed to produce a total score ranging from 0 to 24, with higher scores indicating greater psychological distress.

   Time frame: baseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)

2. Catastrophizing

   Catastrophizing will be assessed using the catastrophizing subscale of the 18-item Cognitive Emotion Regulation Questionnaire (CERQ-18). The CERQ-18 consists of nine 2-item subscales. Each item is rated on a 5-point scale from 1 to 5. The two catastrophizing items are summed to produce a subscale score ranging from 2 to 10, with higher scores indicating more frequent use of catastrophizing as a cognitive emotion regulation strategy.

   Time frame: baseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)

3. Self-Esteem

   Global self-esteem will be assessed using the 10-item Rosenberg Self-Esteem Scale (RSES). Each item is rated on a 4-point scale from 1 to 4, with negatively worded items reverse-scored. Item scores are summed to produce a total score ranging from 10 to 40, with higher scores indicating higher levels of global self-esteem.

   Time frame: baseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)

4. Emotional clarity

   Emotional clarity will be assessed using the Lack of Emotional Clarity subscale of the 18-item Difficulties in Emotion Regulation Scale-Short Form (DERS-SF). The subscale consists of two items, each rated on a 5-point scale from 1 to 5. Item scores are summed to yield a total score ranging from 2 to 10, with higher scores indicating greater difficulties in emotional clarity.

   Time frame: baseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)

Secondary outcomes

1. Depressive Symptoms

   Depressive symptoms will be assessed using the 9-item Patient Health Questionnaire (PHQ-9). Each item is rated according to symptom frequency over the preceding 2 weeks on a 4-point scale from 0 (not at all) to 3 (nearly every day). Item scores are summed to produce a total score ranging from 0 to 27, with higher scores indicating greater severity of depressive symptoms.

   Time frame: baseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)

2. Anxiety Symptoms

   Anxiety symptoms will be assessed using the 7-item Generalized Anxiety Disorder scale (GAD-7). Each item is rated according to symptom frequency over the preceding 2 weeks on a 4-point scale from 0 (not at all) to 3 (nearly every day). Item scores are summed to produce a total score ranging from 0 to 21, with higher scores indicating greater severity of anxiety symptoms.

   Time frame: baseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)

3. Eating Disorder Symptoms

   Eating disorder symptoms will be assessed using the Chinere version of the 12-item Eating Disorder Examination Questionnaire-Short Form (EDE-QS). Each item is scored from 0 to 3. Item scores are summed to produce a total score ranging from 0 to 36, with higher scores indicating greater severity of eating disorder symptoms.

   Time frame: baseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)

4. Insomnia Severity

   Insomnia symptoms will be assessed using the 7-item Insomnia Severity Index (ISI). Each item is rated on a 5-point scale from 0 to 4. Item scores are summed to produce a total score ranging from 0 to 28, with higher scores indicating greater insomnia severity.

   Time frame: baseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)

5. Somatic Symptom Severity

   Somatic symptoms will be assessed using the 15-item Patient Health Questionnaire (PHQ-15). Each item is rated on a 3-point scale from 0 (not bothered at all) to 2 (bothered a lot). Item scores are summed to produce a total score ranging from 0 to 30, with higher scores indicating greater somatic symptom severity.

   Time frame: baseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)

6. Suicidal Ideation

   Suicidal ideation will be assessed using the first five screening items of the Beck Scale for Suicide Ideation (BSS). Each item assesses suicidal thoughts and attitudes over the preceding week, and is rated on a 3-point scale from 0 to 2. Item scores are summed to produce a total score ranging from 0 to 10, with higher scores indicating greater severity of suicidal ideation.

   Time frame: baseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)

7. Self-Injurious Behavior

   Self-injurious behavior will be assessed using four self-developed items. These items assess whether participants engaged in self-injury during the preceding week, the frequency of self-injurious acts, the number of days on which self-injury occurred, and the perceived likelihood of engaging in self-injury again. Higher values indicate more frequent self-injury or greater perceived likelihood of future self-injury.

   Time frame: baseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)

8. Urges to Engage in Self-Injury

   Urges to engage in self-injury will be assessed using the 5-item Alexian Brothers Urge to Self-Injure Scale (ABUSI). The scale assesses the frequency, intensity, duration, difficulty resisting, and overall severity of self-injury urges over the preceding week. Each item is rated on a 7-point scale from 0 to 6. Item scores are summed to produce a total score ranging from 0 to 30, with higher scores indicating greater severity of self-injury urges.

   Time frame: baseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)

9. Urgency

   Negative and positive urgency will be assessed using the Negative Urgency and Positive Urgency subscale of the Short UPPS-P Impulsive Behavior Scale (SUPPS-P), respectively. Each subscale contains 4 items rated on a 4-point scale from 1 to 4. After appropriate reverse scoring, the four items are summed to produce a score ranging from 4 to 16, with higher scores indicating a greater tendency to act impulsively when experiencing intense emotions.

   Time frame: baseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)

10. Aggression

    Aggression will be assessed using the 12-item Brief Aggression Questionnaire (BAQ). The scale measures four dimensions of aggression: physical aggression, verbal aggression, anger, and hostility. Each item is rated on a 7-point scale from 1 (extremely uncharacteristic of me) to 7 (extremely characteristic of me). After reverse-scoring the relevant item, scores are summed to produce a total score ranging from 12 to 84, with higher scores indicating greater levels of aggression.

    Time frame: baseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)

11. Functional Impairment

    Functional impairment will be assessed using the Sheehan Disability Scale (SDS). The scale contains 3 items assessing impairment in work or school, social life, and family life or home responsibilities. Each item is rated from 0 to 10. The three items are summed to produce a total score ranging from 0 to 30, with higher scores indicating greater functional impairment.

    Time frame: baseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)

12. Life Satisfaction

    Life satisfaction will be assessed using the 5-item Satisfaction With Life Scale (SWLS). Each item is rated on a 7-point scale from 1 to 7. Item scores are summed to produce a total score ranging from 5 to 35, with higher scores indicating greater satisfaction with life.

    Time frame: baseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)

13. Study Retention Rate

    Study retention will be assessed as the proportion of enrolled participants who complete the post-intervention and follow-up assessment.

    Time frame: post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)

14. Intervention acceptability

    Intervention acceptability will be assessed using an adapted version of the Chinese Acceptability of Intervention Measure (cAIM). In addition to the original cAIM items, the adapted measure includes items assessing participants' willingness to recommend the intervention to friends and their willingness to continue using the intervention, informed by Wang et al. (2024). All items are rated on a 5-point scale from 1 (completely disagree) to 5 (completely agree), with higher scores indicating greater perceived acceptability of the intervention.

    Time frame: post-treatment (2 weeks)

Other outcomes

1. Alcohol Use

   Alcohol use will be assessed using the 3-item Alcohol Use Disorders Identification Test-Consumption (AUDIT-C). The scale assesses alcohol consumption over the preceding 12 months, including drinking frequency, typical quantity of alcohol consumed, and frequency of heavy episodic drinking. Each item is rated on a 5-point scale from 0 to 4. Item scores are summed to produce a total score ranging from 0 to 12, with higher scores indicating greater alcohol consumption and increased risk of hazardous drinking.

   Time frame: baseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)

2. Externalizing Behaviors

   Externalizing behaviors will be assessed using an 11-item self-developed questionnaire. The questionnaire assesses the frequency of externalizing behaviors over the preceding 2 weeks, including rule-breaking, verbal and physical aggression, and impulsive behaviors. Each item is rated on a 5-point scale from 0 to 4, with higher scores indicating more frequent occurrence of externalizing behaviors. Item scores are summed to produce a total score ranging from 0 to 44, with higher scores indicating greater levels of externalizing behaviors.

   Time frame: baseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)

3. Psychotic-Like Experiences

   Psychotic-like experiences will be assessed using the 16-item Prodromal Questionnaire (PQ-16). The questionnaire assesses perceptual abnormalities, unusual thought content, and negative symptoms. Each item is rated as either present (1) or absent (0), with endorsed experiences further rated for associated distress on a 4-point scale from 0 (no distress) to 3 (severe distress). The total symptom score ranges from 0 to 16, and the total distress score ranges from 0 to 48, with higher scores indicating more psychotic-like experiences or greater associated distress, respectively.

   Time frame: baseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)

4. Complex Posttraumatic Stress Disorder Symptoms

   Complex posttraumatic stress disorder (CPTSD) symptoms will be assessed using the International Trauma Questionnaire (ITQ). The questionnaire includes 12 symptom items assessing posttraumatic stress disorder (PTSD) symptoms and disturbances in self-organization (DSO), along with 6 additional items assessing associated functional impairment. Each item is rated on a 5-point scale from 0 (not at all) to 4 (extremely). The 12 symptom items are summed to produce a total score ranging from 0 to 48, with higher scores indicating greater severity of CPTSD symptoms.

   Time frame: baseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)

5. Self-Compassion

   Self-compassion will be assessed using the 12-item Self-Compassion Scale-Short Form (SCS-SF). Each item is rated on a 5-point scale from 1 (almost never) to 5 (almost always). Negatively worded items are reverse-scored, and an overall mean score ranging from 1 to 5 is calculated, with higher scores indicating greater self-compassion.

   Time frame: baseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)

6. Difficulties in Emotion Regulation

   Difficulties in emotion regulation will be assessed using the 18-item Difficulties in Emotion Regulation Scale-Short Form (DERS-SF). The scale measures six dimensions: emotional awareness, emotional clarity, nonacceptance of emotional responses, difficulties engaging in goal-directed behavior, impulse control difficulties, and limited access to emotion regulation strategies. Each item is rated on a 5-point scale from 1 (almost never) to 5 (almost always). After reverse-scoring the relevant items, scores are summed to produce a total score ranging from 18 to 90, with higher scores indicating greater difficulties in emotion regulation.

   Time frame: baseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)

7. Cognitive Emotion Regulation Strategies

   Cognitive emotion regulation strategies will be assessed using the 18-item Cognitive Emotion Regulation Questionnaire-Short Form (CERQ-18). The questionnaire measures nine strategies: self-blame, other-blame, rumination, catastrophizing, acceptance, positive refocusing, refocus on planning, positive reappraisal, and putting into perspective. Each item is rated on a 5-point scale from 1 (almost never) to 5 (almost always). Each strategy is assessed using two items, with subscale scores ranging from 2 to 10. Higher scores indicate more frequent use of the corresponding cognitive emotion regulation strategy.

   Time frame: baseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)

8. Self-esteem Instability

   The Labile Self-Esteem Scale was used to measure the stability of self-esteem. The LSES consists of five items, each rated on a 5-point scale from 1 ("strongly disagree") to 5 ("strongly agree"). The total score is the sum of all items (range: 5-25), with higher scores indicating more unstable self-esteem.

   Time frame: baseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)

Individual participant data

Plan to share: No