Adults 18 to 29, any sex, with Depression or Suicidality. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Depression.Primary· Baseline, Post Intervention (day 5), and 3 Months.
Depression will be measured using the Center for Epidemiological Studies -- Depression Scale (CESD). An overall depression score is computed as the sum of 20 items, with items 3, 11, 14, and 16 reversed. In cases with internally missing data (items not answered), the sums are computed after imputation of the missing values: # items on scale / # actually answered, multiplied by the sum obtained from the answered items. A range of 0-60, with higher scores indicating more depressive symptomatology during the past week.
Baseline
Group
Value
95% CI
Control
24.75
± 11.83
Expressive Writing (EW)
25.17
± 12.07
Self-Affirmation (SA)
29.06
± 13.41
Post-Intervention
Group
Value
95% CI
Control
21.03
± 11.79
Expressive Writing (EW)
17.42
± 11.46
Self-Affirmation (SA)
21.73
± 13.45
3 Months
Group
Value
95% CI
Control
23.44
± 13.09
Expressive Writing (EW)
18.45
± 10.97
Self-Affirmation (SA)
22.92
± 14.61
Change in Psychological Distress.Primary· Baseline, Post Intervention (day 5), and 3 Months.
Psychological Distress will be measured using the Brief Symptom Inventory (BSI). The BSI consists of 18 items scored 0-4. Items are averaged to yield a final score of 0-4. The higher the score, the greater the psychological distress.
Baseline
Group
Value
95% CI
Control
2.31
± 0.85
Expressive Writing (EW)
2.22
± 0.73
Self-Affirmation (SA)
2.63
± 0.86
Post-Intervention
Group
Value
95% CI
Control
1.84
± 0.77
Expressive Writing (EW)
1.82
± 0.67
Self-Affirmation (SA)
2.08
± 0.86
3 Months
Group
Value
95% CI
Control
2.14
± 0.92
Expressive Writing (EW)
1.77
± 0.65
Self-Affirmation (SA)
2.35
± 0.80
Change in Anxiety.Primary· Baseline, Post Intervention (day 5), and 3 Months.
Anxiety will be measured using the Beck Anxiety Inventory (BAI). The BAI total score is reported, which is the sum of all 21 items; with no subscales. The range of scores is 0-63, with higher scores indicating higher anxiety.
Baseline
Group
Value
95% CI
Control
21.72
± 14.14
Expressive Writing (EW)
20.28
± 12.29
Self-Affirmation (SA)
26.94
± 13.91
Post-Intervention
Group
Value
95% CI
Control
14.73
± 13.43
Expressive Writing (EW)
13.54
± 10.91
Self-Affirmation (SA)
19.47
± 13.16
3 Months
Group
Value
95% CI
Control
18.26
± 13.19
Expressive Writing (EW)
13.03
± 10.55
Self-Affirmation (SA)
19.73
± 10.78
Change in Suicidality - Suicidal Ideation.Primary· Baseline, Post Intervention (day 5), and 3 Months.
Suicidal ideation will be measured using the Suicidal Ideation Attributes Scale (SIDAS) . Total SIDAS scores are calculated as the sum of the five items, with controllability reverse scored (10=0, 9=1, …, 0=10). Total scores range from 0 to 50.
Baseline
Group
Value
95% CI
Control
6.05
± 9.81
Expressive Writing (EW)
4.19
± 6.92
Self-Affirmation (SA)
9.42
± 11.21
Post-Intervention
Group
Value
95% CI
Control
2.36
± 4.08
Expressive Writing (EW)
1.21
± 3.57
Self-Affirmation (SA)
2.70
± 6.24
3 Months
Group
Value
95% CI
Control
4.63
± 8.19
Expressive Writing (EW)
3.87
± 7.40
Self-Affirmation (SA)
5.31
± 7.54
Change in Alcohol Use.Primary· Baseline, Post Intervention, 3 Months
Alcohol use in participants will be assessed using the Alcohol Use Disorders Identification (AUDIT) instrument. The AUDIT consists of 10 items. Each of the questions has a set of responses to choose from, and each response has a score ranging from 0 to 4. All response scores should be added and recorded as "Total". Total scores of 8 or more are recommended as indicators of hazardous and harmful alcohol use, as well as possible alcohol dependence. (A cut-off score of 10 will provide greater specificity but at the expense of sensitivity.) The score range is 0-40. Higher scores indicate greater h
Baseline
Group
Value
95% CI
Control
5.08
± 3.77
Expressive Writing (EW)
4.25
± 4.29
Self-Affirmation (SA)
5.97
± 6.00
Post-Intervention
Group
Value
95% CI
Control
4.67
± 4.00
Expressive Writing (EW)
3.70
± 4.33
Self-Affirmation (SA)
3.73
± 4.35
3 Months
Group
Value
95% CI
Control
5.26
± 4.62
Expressive Writing (EW)
2.91
± 3.76
Self-Affirmation (SA)
5.58
± 5.98
Change in Drug Use.Primary· Baseline, Post Intervention (day 5), and 3 Months.
The Short Inventory of Problems-Modified for Drug Use (SIP-DU) is a 15-item scale that asks respondents to rate each item on a dichotomous scale ("No" = 0, "Yes" = 1). Total score reported, which is the sum of all items; no subscales: Range 0-15, higher scores indicate greater problems with drug use.
Baseline
Group
Value
95% CI
Control
0.39
± 0.99
Expressive Writing (EW)
0.31
± 0.98
Self-Affirmation (SA)
1.47
± 2.99
Post-Intervention
Group
Value
95% CI
Control
0.36
± 1.03
Expressive Writing (EW)
0.67
± 2.53
Self-Affirmation (SA)
0.57
± 1.70
3 Months
Group
Value
95% CI
Control
0.33
± 0.83
Expressive Writing (EW)
0.84
± 2.89
Self-Affirmation (SA)
1.58
± 3.56
Suicidal IntentPrimary· Baseline, Post Intervention (day 5), and 3 Months.
Suicidal intent will be assessed using a single item that asks: Within the last 3 months/past week, have you seriously considered attempting suicide? \[yes/no\] Number of participants who reported suicidal intent is reported. Originally titled "Change in Suicidality - Suicidal Thoughts".
Baseline
Group
Value
95% CI
Control
4
Expressive Writing (EW)
4
Self-Affirmation (SA)
9
Post-Intervention
Group
Value
95% CI
Control
0
Expressive Writing (EW)
0
Self-Affirmation (SA)
1
3 Months
Group
Value
95% CI
Control
3
Expressive Writing (EW)
1
Self-Affirmation (SA)
2
Attempted SuicidePrimary· Baseline, Post Intervention (day 5), and 3 Months.
Suicide attempts will be assessed using a single item that asks: Within the last past 3 months/past week, have you actually attempted suicide? \[yes/no\]. Reported are the number of participants who reported that they had attempted suicide. Original title: "Change in Suicidality: Suicide Attempts".
Baseline
Group
Value
95% CI
Control
1
Expressive Writing (EW)
0
Self-Affirmation (SA)
1
Post-Intervention
Group
Value
95% CI
Control
0
Expressive Writing (EW)
0
Self-Affirmation (SA)
0
3 Months
Group
Value
95% CI
Control
0
Expressive Writing (EW)
0
Self-Affirmation (SA)
0
Self Injury.Secondary· Baseline, Post Intervention (day 5), and 3 Months.
Self injury behaviors will be assessed with the item that asks: How many times in the past 3 months/past week have you engaged in self-harm behavior (e.g., cutting, biting, burning, hitting self) with the intent of harming, but not killing, yourself? Reported are the frequency of self-harm behaviors/self-injury reported by participants. Original title: "Change in Self Injury".
Baseline
Group
Value
95% CI
Control
0.61
± 1.50
Expressive Writing (EW)
1.36
± 5.11
Self-Affirmation (SA)
0.94
± 2.11
Post-Intervention
Group
Value
95% CI
Control
0.12
± 0.48
Expressive Writing (EW)
0.21
± 1.22
Self-Affirmation (SA)
0.07
± 0.25
3 Months
Group
Value
95% CI
Control
0.26
± 0.71
Expressive Writing (EW)
0.97
± 4.45
Self-Affirmation (SA)
1.27
± 3.97
RuminationSecondary· Baseline, Post Intervention (day 5), and 3 Months.
Rumination will be assessed using the Ruminative Response Scale - Brooding Subscale (RRS). This scale is modified from the original measure where only items 5, 10, 13, 15 and 16 are used. Each item is scored by respondents on a scale of 1 to 4. To get the overall score, the 5 items are summed; total scores range from 5-20, with higher scores indicating greater brooding and rumination (related to depression) in an individual.
Baseline
Group
Value
95% CI
Control
12.39
± 3.68
Expressive Writing (EW)
12.97
± 3.48
Self-Affirmation (SA)
13.03
± 3.55
Post-Intervention
Group
Value
95% CI
Control
11.58
± 3.57
Expressive Writing (EW)
11.67
± 3.48
Self-Affirmation (SA)
12.10
± 4.41
3 Months
Group
Value
95% CI
Control
11.44
± 4.86
Expressive Writing (EW)
10.81
± 3.81
Self-Affirmation (SA)
11.81
± 3.62
Perceived SupportSecondary· Baseline, Post Intervention (day 5), and 3 Months.
Perceived social support is measured using the Multidimensional Scale of Perceived Social Support (MSPSS). The MSPSS is a 12 item instrument that uses a scale 1-7 to rate each item. The scoring is done by taking the average of the items- therefore a score of 7 indicates the highest level of perceived social support.
Baseline
Group
Value
95% CI
Control
5.11
± 1.30
Expressive Writing (EW)
5.35
± 0.94
Self-Affirmation (SA)
4.89
± 1.40
Post-Intervention
Group
Value
95% CI
Control
5.10
± 1.08
Expressive Writing (EW)
5.34
± 0.93
Self-Affirmation (SA)
5.03
± 1.44
3 Months
Group
Value
95% CI
Control
5.12
± 1.39
Expressive Writing (EW)
5.53
± 1.01
Self-Affirmation (SA)
5.09
± 1.65
HopelessnessSecondary· Baseline, Post Intervention, 3 Months
Hopelessness will be measured using the Beck Hopelessness Scale (BHS). The BHS is a 20-item dichotomous scale ("No" = 0, "Yes" = 1). Items 1, 3, 5, 6, 8, 10, 13, 15 and 19 are reverse-scored. The total score is out of 20, where 20 would be the highest score and considered a negative indicator of hopelessness.
Baseline
Group
Value
95% CI
Control
7.00
± 6.08
Expressive Writing (EW)
5.14
± 4.28
Self-Affirmation (SA)
7.44
± 6.07
Post-Intervention
Group
Value
95% CI
Control
6.93
± 6.31
Expressive Writing (EW)
4.88
± 4.87
Self-Affirmation (SA)
7.80
± 6.51
3 Months
Group
Value
95% CI
Control
5.85
± 5.80
Expressive Writing (EW)
5.19
± 5.07
Self-Affirmation (SA)
7.77
± 7.00
Sponsor's own description
The purpose of this study is to test the feasibility of writing interventions specifically designed for lesbian, gay, and bisexual (LGB) emerging adults (ages 18-29) that are aimed at improving the outcomes: depression, suicidality, substance abuse and HIV risk behaviors.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Yale University
Last refreshed: 28 August 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03751020.